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A Study Of PF-06647020 For Adult Patients With Advanced Solid Tumors

A FIRST-IN-HUMAN PHASE 1, DOSE ESCALATION, SAFETY AND PHARMACOKINETIC STUDY OF PF-06647020 IN ADULT PATIENTS WITH ADVANCED SOLID TUMORS

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02222922
Enrollment
138
Registered
2014-08-22
Start date
2014-10-17
Completion date
2019-11-05
Last updated
2020-12-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neoplasms

Keywords

ADC, PF-06647020, solid tumors, tumors, neoplasm metastasis, TNBC, triple negative breast cancer, NSCLC, non small cell lung cancer, advanced metastatic breast cancer, ovarian cancer, OVCA

Brief summary

To assess the safety and tolerability at increasing dose levels of PF-06647020 in patients with advanced solid tumors in order to determine the maximum tolerated dose and select the recommended Phase 2 dose.

Interventions

DRUGPF-06647020 Q3W

Part 1: PF-06647020 will be administered intravenously every 21 days in cohorts of 2-4 patients starting at a dose of 0.20mg/kg. Increases in dose will continue until MTD is determined. Part 2: Patients with triple negative breast cancer (pre-selected for PTK7 moderately high to high expression), non small cell lung cancer (pre-selected with moderate to high PTK7 expression) and ovarian cancer patients (unselected for PTK7 expression) will be treated at the MTD or Recommended Phase 2 Dose selected in Part 1.

DRUGfluconazole

combination drug used for drug-drug interaction sub-study

DRUGPF-06647020 Q2W

Part 1: PF-06647020 will be administered intravenously every 14 days in cohorts of 2-4 patients starting at a dose of 2.1 mg/kg. Increases in dose will continue until MTD is determined. Part 2: Patients with non-small cell lung cancer (pre-selected for PTK7 moderate to high expression and ovarian cancer patients (unselected for PTK7 expression) will be treated at the MTD or Recommended Phase 2 Dose selected in Part 1.

DRUGPF-06647020 combined with Avelumab

Part 2: Patients with ovarian cancer (unselected for PTK7 expression) will be treated with PF-0664702 plus Avelumab.

Sponsors

Pfizer
Lead SponsorINDUSTRY

Study design

Allocation
NON_RANDOMIZED
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Q2W Inclusion Criteria: * Diagnosis of platinum resistant or refractory OVCA having received 2 or fewer prior lines, or recurrent advanced NSCLC having received 3 or fewer prior lines * Performance Status of 0, 1, or 2 * Adequate bone marrow, kidney, and liver function Q2W

Exclusion criteria

* OVCA pts excluded with any of the following: non-epithelial, including malignant mixed mullerian tumors, unresolved bowel obstruction * Brain metastases requiring steroids * Major surgery, radiation therapy, or systemic anti-cancer therapy within 4 weeks of study treatment start * Active and clinically significant bacterial, fungal, or viral infection Q3W Inclusion Criteria: * Diagnosis of solid tumor that is advanced/metastatic and resistant to standard therapy or for whom no standard therapy is available * Performance Status of 0 or 1 * Adequate bone marrow, kidney, and liver function * Part 2 includes ovarian cancer, target expressing triple negative breast cancer and non small cell lung cancer patients Q3W

Design outcomes

Primary

MeasureTime frameDescription
Number of Participants With Dose Limiting Toxicities (DLTs) - Q3W RegimenFirst Cycle, Day 1 up to Day 21A DLT was any of the following adverse events(AEs) in the first cycle of treatment (within 21 days of first dose or until participant received second infusion if there were treatment delays). (1)Hematologic: including Grade 4 neutropenia lasting \>7 days; Febrile neutropenia; Grade \>=3 neutropenic infection; Grade 4 anemia; Grade \>=3 thrombocytopenia with clinically significant bleeding. (2) Hepatic, including Grade \>=3 serum bilirubin, hepatic transaminase or alkaline phosphatase; alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>=3.0 x upper limit of normal (ULN) concurrent with elevation in bilirubin \>=2.0 x ULN; (3) Grade \>=3 non-hematologic, non-hepatic major organ toxicities; delayed by \>2 weeks in receiving the next scheduled cycle due to persisting toxicities attributable to PF-06647020. A participant was on study for at least 21 days to be evaluable for DLT observation, and could be replaced if they terminated study participation earlier than 21 days.
Number of Participants With Treatment-Emergent Adverse Events (AEs) - Q3W Regimen (All-Causality)From the time the participant took the first dose of study medication through the participant's last visit. (approximately 32 months)An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent AEs were those with initial onset or increasing in severity after the first dose of study medication.
Number of Participants With Treatment-Emergent AEs - Q3W Regimen (Treatment-Related)From the time the participant took the first dose of study medication through the participant's last visit. (approximately 32 months)A treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent AEs were those with initial onset or increasing in severity after the first dose of study medication.
Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q3W Regimen (All-Causality and Treatment-Related)From the time the participant took the first dose of study medication through the participant's last visit. (approximately 32 months)An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Treatment-emergent AEs were those with initial onset or increasing in severity after the first dose of study medication. All AEs were graded by the investigator according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Grade 1 AEs are mild AEs; Grade 2 AEs are moderate AEs; Grade 3 AEs are severe AEs, Grade 4 AEs are life-threatening consequences and Grade 5 AEs are deaths related to AEs. Each AE was counted once for the participant in the most severe severity.
Number of Participants With Hematology Laboratory Abnormalities (All Cycles) - Q3W RegimenFrom baseline to end of treatment (approximately 32 months).Participants who experienced hematology laboratory test abnormalities were summarized according to worst toxicity grade observed for each hematology laboratory test. Laboratory abnormalities were graded by NCI CTCAE version 4.03. This outcome measure calculated the number of participants with hematology laboratory abnormalities that were shifted from \<=Grade 2 at baseline to Grade 3 or above, including the following parameters: absolute neutrophils, lymphopenia, white blood cell, anemia, platelets.
Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q3W RegimenFrom baseline to end of treatment (approximately 32 months).Participants who experienced chemistry laboratory test abnormalities were summarized according to worst toxicity grade observed for each chemistry laboratory test. Laboratory abnormalities were graded by NCI CTCAE version 4.03. This outcome measure calculated the number of participants with chemistry laboratory abnormalities that were shifted from \<=Grade 2 at baseline to Grade 3 or above, including the following parameters: hypokalemia, hypophosphatemia, aspartate aminotransferase, hyperglycemia, alkaline phosphatase, hyponatremia, alanine aminotransferase, hypoalbuminemia, total bilirubin, hypercalcemia, hypomagnesemia , creatinine, gamma glutamyl transferase, hypocalcemia.
Number of Participants With Urinalysis Laboratory Abnormalities (All Cycles) - Q3W RegimenFrom baseline to end of treatment (approximately 32 months).Participants who experienced urinalysis laboratory test abnormalities were summarized according to worst toxicity grade observed for each urinalysis laboratory test. Laboratory abnormalities were graded by NCI CTCAE version 4.03. This outcome measure calculated the number of participants with urinalysis laboratory abnormalities that were shifted from \<=Grade 2 at baseline to Grade 3 or above.
Number of Participants With Coagulation Laboratory Abnormalities (All Cycles) - Q3W RegimenFrom baseline to end of treatment (approximately 32 months).Participants who experienced coagulation laboratory test abnormalities were summarized according to worst toxicity grade observed for each coagulation laboratory test. Laboratory abnormalities were graded by NCI CTCAE version 4.03. This outcome measure calculated the number of participants with coagulation laboratory abnormalities that were shifted from \<=Grade 2 at baseline to Grade 3 or above, including the following parameter: partial thromboplastin time.
Number of Participants With DLTs - Q2W RegimenFirst cycle, Day 1 up to Day 28A DLT was any of the following AEs in the first cycle of treatment (within 28 days of first dose or until participant received second infusion if there were treatment delayed) in the single agent dose escalation. (1)Hematologic: including Grade 4 neutropenia lasting \>7 days; Febrile neutropenia; Grade \>=3 neutropenic infection; Grade 4 thrombocytopenia; treatment delay \>14 days because of hematologic AE; (2) Hepatic: including Grade\>=3 serum bilirubin, hepatic transaminase or alkaline phosphatase; ALT or AST\>=3.0 x ULN concurrent with elevation in bilirubin\>=2.0 x ULN; (3) Grade \>=3 non-hematologic, non-hepatic major organ toxicities; delayed by \>2 weeks in receiving the next scheduled cycle due to persisting toxicities attributable to PF-06647020. Grade \>=3 headache lasting \>48 hours in presence of supportive care. A participant was on study for at least 28 days to be evaluable for DLT observation, and could be replaced if they terminated study participation earlier than 28 days.
Number of Participants With Treatment-Emergent AEs - Q2W Regimen (All-Causality)From the time the participant took the first dose of study medication through the participant's last visit. (approximately 19 months)An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent AEs were those with initial onset or increasing in severity after the first dose of study medication.
Number of Participants With Treatment-Emergent AEs - Q2W Regimen (Treatment-Related)From the time the participant took the first dose of study medication through the participant's last visit. (approximately 19 months)A treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent AEs were those with initial onset or increasing in severity after the first dose of study medication.
Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q2W Regimen (All-Causality and Treatment-Related)From the time the participant took the first dose of study medication through the participant's last visit. (approximately 19 months)An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Treatment-emergent AEs were those with initial onset or increasing in severity after the first dose of study medication. All AEs were graded by the investigator according to the NCI CTCAE version 4.03. Grade 1 AEs are mild AEs; Grade 2 AEs are moderate AEs; Grade 3 AEs are severe AEs, Grade 4 AEs are life-threatening consequences and Grade 5 AEs are deaths related to AEs. Each AE was counted once for the participant in the most severe severity.
Number of Participants With Hematology Laboratory Abnormalities (All Cycles) - Q2W RegimenFrom baseline to end of treatment (approximately 19 months).Participants who experienced hematology laboratory test abnormalities were summarized according to worst toxicity grade observed for each hematology laboratory test. Laboratory abnormalities were graded by NCI CTCAE version 4.03. This outcome measure calculated the number of participants with hematology laboratory abnormalities that were shifted from \<=Grade 2 at baseline to Grade 3 or above, including the following parameters: absolute neutrophils, lymphopenia, white blood cell, anemia.
Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q2W RegimenFrom baseline to end of treatment (approximately 19 months).Participants who experienced chemistry laboratory test abnormalities were summarized according to worst toxicity grade observed for each chemistry laboratory test. Laboratory abnormalities were graded by NCI CTCAE version 4.03. This outcome measure calculated the number of participants with chemistry laboratory abnormalities that were shifted from \<=Grade 2 at baseline to Grade 3 or above, including the following parameters: hypokalemia, hyponatremia, hypomagnesemia, hypoalbuminemia, hypocalcemia, hypophosphatemia, alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase.
Number of Participants With Urinalysis Laboratory Abnormalities (All Cycles) - Q2W RegimenBaseline and Day 1 of Cycle 1Participants who experienced urinalysis laboratory test abnormalities were summarized according to worst toxicity grade observed for each urinalysis laboratory test. Laboratory abnormalities were graded by NCI CTCAE version 4.03. This outcome measure calculated the number of participants with urinalysis laboratory abnormalities that were shifted from \<=Grade 2 at baseline to Grade 3 or above.
Number of Participants With Coagulation Laboratory Abnormalities (All Cycles) - Q2W RegimenFrom baseline to end of treatment (approximately 19 months).Participants who experienced coagulation laboratory test abnormalities were summarized according to worst toxicity grade observed for each urinalysis laboratory test. Laboratory abnormalities were graded by NCI CTCAE version 4.03. This outcome measure calculated the number of participants with coagulation laboratory abnormalities that were shifted from \<=Grade 2 at baseline to Grade 3 or above, including the following parameter: prothrombin time international normalized ratio.

Secondary

MeasureTime frameDescription
AUCtau for hu6M024 mAb - Q3W Regimenpre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 4 (21 days cycle).Tau refers to the dosing interval and it equals to 504 hours for the Q3W dosing. AUCtau is the area under the concentration-time profile from time 0 to time tau. AUCtau for hu6M024 mAb was determined using linear/log trapezoidal method.
Cmax for hu6M024 mAb - Q3W Regimenpre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 4 (21 days cycle).Cmax is maximum observed serum concentration. Cmax for hu6M024 mAb was observed directly from data.
t1/2 for hu6M024 mAb - Q3W Regimenpre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 4 (21 days cycle).Terminal half-life (t1/2) is the time measured for the plasma concentration of drug to decrease by one half.
Rac for hu6M024 mAb - Q3W Regimenpre-dose, 1, 4 hours post-dose on Day 1 of Cycle 1 and Day 1 of Cycle 4 (21 days cycle).Rac is defined as observed accumulation ratio based on dose normalized AUCtau (AUCtau\[dn\]), where AUCtau is the area under the concentration-time profile from time 0 to time tau (tau equals to 504 hours for the Q3W dosing). Rac=Cycle 4 Day 1 AUCtau(dn) (multiple dose) /Cycle 1 Day 1 AUCtau(dn) (single Dose).
Tmax for hu6M024 mAb - Q3W Regimenpre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 4 (21 days cycle).Tmax is the time for Cmax. Tmax for hu6M024 mAb was observed directly from data as time of first occurrence.
AUClast for hu6M024 mAb - Q3W Regimenpre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 4 (21 days cycle).AUClast is the area under the serum concentration-time profile from time 0 to the time of the last quantifiable concentration. AUClast for hu6M024 mAb was determined using linear/log trapezoidal method.
AUCinf for hu6M024 mAb - Q3W Regimenpre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 4 (21 days cycle).AUCinf is the area under the serum concentration-time profile from time 0 extrapolated to infinite time. AUCinf for hu6M024 mAb was calculated as AUClast + (Clast\*/kel), where AUClast was the area under the serum concentration-time profile from time 0 to the time of the last quantifiable concentration, Clast\* was the predicted serum concentration at the last quantifiable time point estimated from the log-linear regression analysis. kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.
Number of Participants With Anti-Drug Antibodies (ADA) and Neutralizing Antibody (NAb) of PF-06647020 - Q3W RegimenPrior to the start of treatment on Day 1 of Cycle 1 up to end of treatment (approximately 31 months).To evaluate the immunogenicity as measured by presence of ADA and NAb in participants treated with PF-06647020.
Percentage of Participants With Objective Response - Q3W RegimenBaseline, every 6 weeks from the start of treatment until disease progression, death or withdrawal from treatment (approximately 32 months).Percentage of participants with objective response based on assessment of complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis \<10 mm). No new lesions. PR was defined as \>=30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions.
t1/2 for hu6M024 mAb - Q2W Regimenpre-dose, end of infusion, 4, 24, 72, 168 hours post-dose, Day 15 (pre-dose, end of infusion) for Cycle 1 and Cycle 3 (28 days cycle).Terminal half-life (t1/2) is the time measured for the plasma concentration of drug to decrease by one half.
Duration of Response - Q3W RegimenBaseline, every 6 weeks from the start of treatment until disease progression, death or withdrawal from treatment (approximately 32 months).Duration of response (DoR) was the time from first documentation of PR or CR to date of first documentation of progressive disease (PD) or death due to any cause. CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis \<10 mm). No new lesions. PR was defined as \>=30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions. PD was defined as at least a 20% increase (including an absolute increase of at least 5 mm) in the sum of diameters of target lesions, taking as reference the smallest sum on study and/or unequivocal progression of existing non-target lesions and/or appearance of one or more new lesions.
Disease Control Rate - Q3W RegimenBaseline, every 6 weeks from the start of treatment until disease progression, death or withdrawal from treatment (approximately 32 months).The disease control rate (DCR) was defined as the percentage of participants with a confirmed CR, PR, non-CR/non-PD or stable disease (SD) according to the appropriate analysis set. CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis \<10 mm). No new lesions. PR was defined as \>=30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.
Time to Progression - Q3W RegimenBaseline, every 6 weeks from the start of treatment until disease progression, death or withdrawal from treatment (approximately 32 months).Time to progression (TTP) was the time from start date to the date of the first documentation of PD. PD was defined as at least a 20% increase (including an absolute increase of at least 5 mm) in the sum of diameters of target lesions, taking as reference the smallest sum on study and/or unequivocal progression of existing non-target lesions and/or appearance of one or more new lesions.
Progression Free Survival - Q3W RegimenBaseline, every 6 weeks from the start of treatment until disease progression, death or withdrawal from treatment (approximately 32 months).Progression free survival (PFS) was the time from randomization date to date of first documentation of PD or death due to any cause. PD was defined as at least a 20% increase (including an absolute increase of at least 5 mm) in the sum of diameters of target lesions, taking as reference the smallest sum on study and/or unequivocal progression of existing non-target lesions and/or appearance of one or more new lesions.
Dose Normalized AUCinf [AUCinf(dn)] for PF-06647020 [DDI Sub-Study]pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 2 (21 days cycle).AUCinf is the area under the serum concentration-time profile from time 0 extrapolated to infinite time. AUCinf(dn) was defined as dose normalized AUCinf and calculated as AUCinf/dose.
Dose Normalized AUClast [AUClast(dn)] for PF-06647020 [DDI Sub-Study]pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 2 (21 days cycle).AUClast is the area under the serum concentration-time profile from time 0 to the time of the last quantifiable concentration. AUClast(dn) was defined as dose normalized AUClast and calculated as AUClast/dose.
Dose Normalized AUCtau [AUCtau(dn)] for PF-06647020 [DDI Sub-Study]pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 2 (21 days cycle).AUCtau is the area under the concentration-time profile from time 0 to time tau. AUCtau(dn) was defined as dose normalized AUCtau and calculated as AUCtau/dose.
Dose Normalized Cmax [Cmax(dn)] for PF-06647020 [DDI Sub-Study]pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 2 (21 days cycle).Cmax is maximum observed serum concentration. Cmax(dn) was defined as dose normalized Cmax and calculated as Cmax/dose.
AUCinf(dn) for PF-06380101 [DDI Sub-Study]pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 2 (21 days cycle).AUCinf is the area under the serum concentration-time profile from time 0 extrapolated to infinite time. AUCinf(dn) was defined as dose normalized AUCinf and calculated as AUCinf/dose.
AUClast(dn) for PF-06380101 [DDI Sub-Study]pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 2 (21 days cycle).AUClast is the area under the serum concentration-time profile from time 0 to the time of the last quantifiable concentration. AUClast(dn) was defined as dose normalized AUClast and calculated as AUClast/dose.
AUCtau(dn) for PF-06380101 [DDI Sub-Study]pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 2 (21 days cycle).AUCtau is the area under the concentration-time profile from time 0 to time tau. AUCtau(dn) was defined as dose normalized AUCtau and calculated as AUCtau/dose.
Cmax(dn) for PF-06380101 [DDI Sub-Study]pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 2 (21 days cycle).Cmax is maximum observed serum concentration. Cmax(dn) was defined as dose normalized Cmax and calculated as Cmax/dose.
AUCinf(dn) for hu6M024 mAb [DDI Sub-Study]pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 2 (21 days cycle).AUCinf is the area under the serum concentration-time profile from time 0 extrapolated to infinite time. AUCinf(dn) was defined as dose normalized AUCinf and calculated as AUCinf/dose.
AUClast(dn) for hu6M024 mAb [DDI Sub-Study]pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 2 (21 days cycle).AUClast is the area under the serum concentration-time profile from time 0 to the time of the last quantifiable concentration. AUClast(dn) was defined as dose normalized AUClast and calculated as AUClast/dose.
AUCtau(dn) for hu6M024 mAb [DDI Sub-Study]pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 2 (21 days cycle).AUCtau is the area under the concentration-time profile from time 0 to time tau. AUCtau(dn) was defined as dose normalized AUCtau and calculated as AUCtau/dose.
Cmax(dn) for hu6M024 mAb [DDI Sub-Study]pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 2 (21 days cycle).Cmax is maximum observed serum concentration. Cmax(dn) was defined as dose normalized Cmax and calculated as Cmax/dose.
AUCtau for PF-06647020 - Q2W Regimenpre-dose, end of infusion, 4, 24, 72, 168 hours post-dose, Day 15 (pre-dose, end of infusion) for Cycle 1 and Cycle 3 (28 days cycle).Tau refers to the dosing interval and it equals to 336 hours for the Q2W dosing. AUCtau is the area under the concentration-time profile from time 0 to time tau. AUCtau for PF-06647020 was determined using linear/log trapezoidal method.
Cmax for PF-06647020 -Q2W Regimenpre-dose, end of infusion, 4, 24, 72, 168 hours post-dose, Day 15 (pre-dose, end of infusion) for Cycle 1 and Cycle 3 (28 days cycle).Cmax is maximum observed serum concentration. Cmax for PF-06647020 was observed directly from data.
Vss for PF-06647020 - Q2W Regimenpre-dose, end of infusion, 4, 24, 72, 168 hours post-dose, Day 15 (pre-dose, end of infusion) for Cycle 1 and Cycle 3 (28 days cycle).Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady-state.
CL for PF-06647020 - Q2W Regimenpre-dose, end of infusion, 4, 24, 72, 168 hours post-dose, Day 15 (pre-dose, end of infusion) for Cycle 1 and Cycle 3 (28 days cycle).Clearance (CL) is a quantitative measure of the rate at which a drug substance is removed from the body. Clearance for PF-06647020 was calculated as dose/AUCinf for single dose and dose/AUCtau for multiple dose, where AUCinf was the area under the serum concentration-time profile from time 0 extrapolated to infinite time and AUCtau was the area under the concentration-time profile from time 0 to time tau (tau equals to 336 hours for the Q2W dosing).
t1/2 for PF-06647020 - Q2W Regimenpre-dose, end of infusion, 4, 24, 72, 168 hours post-dose, Day 15 (pre-dose, end of infusion) for Cycle 1 and Cycle 3 (28 days cycle).Terminal half-life (t1/2) is the time measured for the plasma concentration of drug to decrease by one half.
Rac for PF-06647020 - Q2W Regimenpre-dose, end of infusion, 4 hours post-dose on Day 1 of Cycle 1 and Day 1 of Cycle 3 (28 days cycle).Rac is defined as observed accumulation ratio based on dose normalized AUCtau (AUCtau\[dn\]), where AUCtau is the area under the concentration-time profile from time 0 to time tau (tau equals to 336 hours for the Q2W dosing). Rac= Cycle 3 Day 1 AUCtau(dn) (multiple dose) /Cycle 1 Day 1 AUCtau(dn) (single Dose).
Tmax for PF-06647020 - Q2W Regimenpre-dose, end of infusion, 4, 24, 72, 168 hours post-dose, Day 15 (pre-dose, end of infusion) for Cycle 1 and Cycle 3 (28 days cycle).Tmax is the time for Cmax. Tmax for PF-06647020 was observed directly from data as time of first occurrence.
AUClast for PF-06647020 - Q2W Regimenpre-dose, end of infusion, 4, 24, 72, 168 hours post-dose, Day 15 (pre-dose, end of infusion) for Cycle 1 and Cycle 3 (28 days cycle).AUClast is the area under the serum concentration-time profile from time 0 to the time of the last quantifiable concentration. AUClast for PF-06647020 was determined using linear/log trapezoidal method.
AUCinf for PF-06647020 - Q2W Regimenpre-dose, end of infusion, 4, 24, 72, 168 hours post-dose, Day 15 (pre-dose, end of infusion) for Cycle 1 and Cycle 3 (28 days cycle).AUCinf is the area under the serum concentration-time profile from time 0 extrapolated to infinite time. AUCinf was calculated as AUClast + (Clast\*/kel), where AUClast was the area under the serum concentration-time profile from time 0 to the time of the last quantifiable concentration, Clast\* was the predicted serum concentration at the last quantifiable time point estimated from the log-linear regression analysis. kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.
AUCtau for PF-06380101 - Q2W Regimenpre-dose, end of infusion, 4, 24, 72, 168 hours post-dose, Day 15 (pre-dose, end of infusion) for Cycle 1 and Cycle 3 (28 days cycle).Tau refers to the dosing interval and it equals to 336 hours for the Q2W dosing. AUCtau is the area under the concentration-time profile from time 0 to time tau. AUCtau for PF-06380101 was determined using linear/log trapezoidal method.
Cmax for PF-06380101 - Q2W Regimenpre-dose, end of infusion, 4, 24, 72, 168 hours post-dose, Day 15 (pre-dose, end of infusion) for Cycle 1 and Cycle 3 (28 days cycle).Cmax is maximum observed serum concentration. Cmax for PF-06380101 was observed directly from data.
Area Under the Concentration-Time Profile From Time 0 to Time Tau (AUCtau) for PF-06647020 - Q3W Regimenpre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 4 (21 days cycle).Tau refers to the dosing interval and it equals to 504 hours for the Q3W dosing. AUCtau is the area under the concentration-time profile from time 0 to time tau. AUCtau for PF-06647020 was determined using linear/log trapezoidal method.
Rac for PF-06380101 - Q2W Regimenpre-dose, end of infusion, 4 hours post-dose on Day 1 of Cycle 1 and Day 1 of Cycle 3 (28 days cycle).Rac is defined as observed accumulation ratio based on dose normalized AUCtau (AUCtau\[dn\]), where AUCtau is the area under the concentration-time profile from time 0 to time tau (tau equals to 336 hours for the Q2W dosing). Rac= Cycle 3 Day 1 AUCtau(dn) (multiple dose) /Cycle 1 Day 1 AUCtau(dn) (single Dose).
Tmax for PF-06380101 - Q2W Regimenpre-dose, end of infusion, 4, 24, 72, 168 hours post-dose, Day 15 (pre-dose, end of infusion) for Cycle 1 and Cycle 3 (28 days cycle).Tmax is the time for Cmax. Tmax for PF-06380101 was observed directly from data as time of first occurrence.
AUClast for PF-06380101- Q2W Regimenpre-dose, end of infusion, 4, 24, 72, 168 hours post-dose, Day 15 (pre-dose, end of infusion) for Cycle 1 and Cycle 3 (28 days cycle).AUClast is the area under the serum concentration-time profile from time 0 to the time of the last quantifiable concentration. AUClast for PF-06380101 was determined using linear/log trapezoidal method.
AUCinf for PF-06380101- Q2W Regimenpre-dose, end of infusion, 4, 24, 72, 168 hours post-dose, Day 15 (pre-dose, end of infusion) for Cycle 1 and Cycle 3 (28 days cycle).AUCinf is the area under the serum concentration-time profile from time 0 extrapolated to infinite time. AUCinf was calculated as AUClast + (Clast\*/kel), where AUClast was the area under the serum concentration-time profile from time 0 to the time of the last quantifiable concentration, Clast\* was the predicted serum concentration at the last quantifiable time point estimated from the log-linear regression analysis. kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.
AUCtau for hu6M024 mAb- Q2W Regimenpre-dose, end of infusion, 4, 24, 72, 168 hours post-dose, Day 15 (pre-dose, end of infusion) for Cycle 1 and Cycle 3 (28 days cycle).Tau refers to the dosing interval and it equals to 336 hours for the Q2W dosing. AUCtau is the area under the concentration-time profile from time 0 to time tau. AUCtau for hu6M024 mA was determined using linear/log trapezoidal method.
Cmax for hu6M024 mAb -Q2W Regimenpre-dose, end of infusion, 4, 24, 72, 168 hours post-dose, Day 15 (pre-dose, end of infusion) for Cycle 1 and Cycle 3 (28 days cycle).Cmax is maximum observed serum concentration. Cmax for hu6M024 mAb was observed directly from data.
Rac for hu6M024 mAb - Q2W Regimenpre-dose, end of infusion, 4 hours post-dose on Day 1 of Cycle 1 and Day 1 of Cycle 3 (28 days cycle).Rac is defined as observed accumulation ratio based on dose normalized AUCtau (AUCtau\[dn\]), where AUCtau is the area under the concentration-time profile from time 0 to time tau (tau equals to 336 hours for the Q2W dosing). Rac= Cycle 3 Day 1 AUCtau(dn) (multiple dose) /Cycle 1 Day 1 AUCtau(dn) (single Dose).
Tmax for hu6M024 mAb - Q2W Regimenpre-dose, end of infusion, 4, 24, 72, 168 hours post-dose, Day 15 (pre-dose, end of infusion) for Cycle 1 and Cycle 3 (28 days cycle).Tmax is the time for Cmax. Tmax for hu6M024 mAb was observed directly from data as time of first occurrence.
AUClast for hu6M024 mAb - Q2W Regimenpre-dose, end of infusion, 4, 24, 72, 168 hours post-dose, Day 15 (pre-dose, end of infusion) for Cycle 1 and Cycle 3 (28 days cycle).AUClast is the area under the serum concentration-time profile from time 0 to the time of the last quantifiable concentration. AUClast for hu6M024 mAb was determined using linear/log trapezoidal method.
AUCinf for hu6M024 mAb - Q2W Regimenpre-dose, end of infusion, 4, 24, 72, 168 hours post-dose, Day 15 (pre-dose, end of infusion) for Cycle 1 and Cycle 3 (28 days cycle).AUCinf is the area under the serum concentration-time profile from time 0 extrapolated to infinite time. AUCinf was calculated as AUClast + (Clast\*/kel), where AUClast was the area under the serum concentration-time profile from time 0 to the time of the last quantifiable concentration, Clast\* was the predicted serum concentration at the last quantifiable time point estimated from the log-linear regression analysis. kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.
Number of Participants With ADA and NAb of PF-06647020 - Q2W Regimen2 hours before the first dose up to 30 days after the last dose (approximately 18 months).To evaluate the immunogenicity as measured by presence of ADA and NAb in participants treated with PF-06647020.
Percentage of Participants With Objective Response - Q2W RegimenBaseline, every 8 weeks from the start of study treatment until disease progression, death or withdrawal from treatment (approximately 19 months).Percentage of participants with objective response based on assessment of CR or PR according to RECIST version 1.1. CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis \<10 mm). No new lesions. PR was defined as \>=30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions.
Duration of Response - Q2W RegimenBaseline, every 8 weeks from the start of study treatment until disease progression, death or withdrawal from treatment (approximately 19 months).For participants with an objective response, duration of response (DoR) was the time from first documentation of PR or CR to date of first documentation of PD or death due to any cause. CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis \<10 mm). No new lesions. PR was defined as \>=30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions. PD was defined as at least a 20% increase (including an absolute increase of at least 5 mm) in the sum of diameters of target lesions, taking as reference the smallest sum on study and/or unequivocal progression of existing non-target lesions and/or appearance of one or more new lesions.
Disease Control Rate - Q2W RegimenBaseline, every 8 weeks from the start of study treatment until disease progression, death or withdrawal from treatment (approximately 19 months).The disease control rate (DCR) was defined as the percentage of participants with a confirmed CR, PR or SD according to the appropriate analysis set. CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis \<10 mm). No new lesions. PR was defined as \>=30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.
Time to Progression - Q2W RegimenBaseline, every 8 weeks from the start of study treatment until disease progression, death or withdrawal from treatment (approximately 19 months).Time to progression (TTP) was the time from start date to the date of the first documentation of PD. PD was defined as at least a 20% increase (including an absolute increase of at least 5 mm) in the sum of diameters of target lesions, taking as reference the smallest sum on study and/or unequivocal progression of existing non-target lesions and/or appearance of one or more new lesions.
Progression Free Survival - Q2W RegimenBaseline, every 8 weeks from the start of study treatment until disease progression, death or withdrawal from treatment (approximately 19 months).Progression free survival (PFS) was the time from randomization date to date of first documentation of PD or death due to any cause. PD was defined as at least a 20% increase (including an absolute increase of at least 5 mm) in the sum of diameters of target lesions, taking as reference the smallest sum on study and/or unequivocal progression of existing non-target lesions and/or appearance of one or more new lesions.
t1/2 for PF-06380101 - Q2W Regimenpre-dose, end of infusion, 4, 24, 72, 168 hours post-dose, Day 15 (pre-dose, end of infusion) for Cycle 1 and Cycle 3 (28 days cycle).Terminal half-life (t1/2) is the time measured for the plasma concentration of drug to decrease by one half.
Maximum Observed Serum Concentration (Cmax) for PF-06647020 -Q3W Regimenpre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 4 (21 days cycle).Cmax is maximum observed serum concentration. Cmax for PF-06647020 was observed directly from data.
Clearance (CL) for PF-06647020 - Q3W Regimenpre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 4 (21 days cycle).Clearance (CL) is a quantitative measure of the rate at which a drug substance is removed from the body. Clearance for PF-06647020 was calculated as dose/AUCinf for single dose and dose/AUCtau for multiple dose, where AUCinf was the area under the serum concentration-time profile from time 0 extrapolated to infinite time and AUCtau was the area under the concentration-time profile from time 0 to time tau (tau equals to 504 hours for the Q3W dosing).
Volume of Distribution at Steady State (Vss) for PF-06647020 - Q3W Regimenpre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 4 (21 days cycle).Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady-state.
Terminal Half-Life (t1/2) for PF-06647020 - Q3W Regimenpre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 4 (21 days cycle).Terminal half-life (t1/2) is the time measured for the plasma concentration of drug to decrease by one half.
Observed Accumulation Ratio (Rac) for PF-06647020 - Q3W Regimenpre-dose, 1, 4 hours post-dose on Day 1 of Cycle 1 and Day 1 of Cycle 4 (21 days cycle).Rac is defined as observed accumulation ratio based on dose normalized AUCtau (AUCtau\[dn\]), where AUCtau is the area under the concentration-time profile from time 0 to time tau (tau equals to 504 hours for the Q3W dosing). Rac=Cycle 4 Day 1 AUCtau(dn) (multiple dose) /Cycle 1 Day 1 AUCtau(dn) (single Dose).
Time for Cmax (Tmax) for PF-06647020 - Q3W Regimenpre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 4 (21 days cycle).Tmax is the time for Cmax. Tmax for PF-06647020 was observed directly from data as time of first occurrence.
Area Under the Concentration-Time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) for PF-06647020 - Q3W Regimenpre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 4 (21 days cycle).AUClast is the area under the serum concentration-time profile from time 0 to the time of the last quantifiable concentration. AUClast for PF-06647020 was determined using linear/log trapezoidal method.
Area Under the Concentration-Time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) for PF-06647020 - Q3W Regimenpre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 4 (21 days cycle).AUCinf is the area under the serum concentration-time profile from time 0 extrapolated to infinite time. AUCinf for PF-06647020 was calculated as AUClast + (Clast\*/kel), where AUClast was the area under the serum concentration-time profile from time 0 to the time of the last quantifiable concentration, Clast\* was the predicted serum concentration at the last quantifiable time point estimated from the log-linear regression analysis. kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.
AUCtau for PF-06380101 - Q3W Regimenpre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 4 (21 days cycle).Tau refers to the dosing interval and it equals to 504 hours for the Q3W dosing. AUCtau is the area under the concentration-time profile from time 0 to time tau. AUCtau for PF-06380101 was determined using linear/log trapezoidal method.
Cmax for PF-06380101 - Q3W Regimenpre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 4 (21 days cycle).Cmax is maximum observed serum concentration. Cmax for PF-06380101 was observed directly from data.
t1/2 for PF-06380101 - Q3W Regimenpre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 4 (21 days cycle).Terminal half-life (t1/2) is the time measured for the plasma concentration of drug to decrease by one half.
Rac for PF-06380101 - Q3W Regimenpre-dose, 1, 4 hours post-dose on Day 1 of Cycle 1 and Day 1 of Cycle 4 (21 days cycle).Rac is defined as observed accumulation ratio based on dose normalized AUCtau (AUCtau\[dn\]), where AUCtau is the area under the concentration-time profile from time 0 to time tau (tau equals to 504 hours for the Q3W dosing). Rac=Cycle 4 Day 1 AUCtau(dn) (multiple dose) /Cycle 1 Day 1 AUCtau(dn) (single Dose).
Tmax for PF-06380101 - Q3W Regimenpre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 4 (21 days cycle).Tmax is the time for Cmax. Tmax for PF-06380101 was observed directly from data as time of first occurrence.
AUClast for PF-06380101 - Q3W Regimenpre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 4 (21 days cycle).AUClast is the area under the serum concentration-time profile from time 0 to the time of the last quantifiable concentration. AUClast for PF-06380101 was determined using linear/log trapezoidal method.
AUCinf for PF-06380101 - Q3W Regimenpre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 4 (21 days cycle).AUCinf is the area under the serum concentration-time profile from time 0 extrapolated to infinite time. AUCinf for PF-06380101 was calculated as AUClast + (Clast\*/kel), where AUClast was the area under the serum concentration-time profile from time 0 to the time of the last quantifiable concentration, Clast\* was the predicted serum concentration at the last quantifiable time point estimated from the log-linear regression analysis. kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.

Countries

Spain, United States

Participant flow

Pre-assignment details

Once every 3 weeks (Q3W) Regimen: A total of 113 participants were enrolled to study treatments and 1 participant in the PF-06647020 2.1 mg/kg treatment group didn't receive any study treatment. Once every 2 weeks (Q2W) Regimen: A total of 25 participants were enrolled to study treatments and all were treated with study drug.

Participants by arm

ArmCount
PF-06647020 0.2 mg/kg (Q3W Regimen)
Participants received PF-06647020 at 0.2 mg/kg on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 4.8 months.
2
PF-06647020 0.5 mg/kg (Q3W Regimen)
Participants received PF-06647020 at 0.5 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 0.7 months.
2
PF-06647020 1.25 mg/kg (Q3W Regimen)
Participants received PF-06647020 at 1.25 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 3.5 months.
2
PF-06647020 2.1 mg/kg (Q3W Regimen)
Participants received PF-06647020 at 2.1 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 8.6 months.
4
PF-06647020 2.8 mg/kg (Q3W Regimen)
Participants received PF-06647020 at 2.8 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 30 months.
96
PF-06647020 3.7 mg/kg (Q3W Regimen)
Participants received PF-06647020 at 3.7 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 8.6 months.
6
PF-06647020 2.1 mg/kg (Q2W Regimen)
Participants received PF-06647020 at 2.1 mg/kg on Days 1 and 15 of each 28-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 3.2 months.
3
PF-06647020 2.8 mg/kg (Q2W Regimen)
Participants received PF-06647020 at 2.8 mg/kg on Days 1 and 15 of each 28-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 16.4 months.
10
PF-06647020 3.2 mg/kg (Q2W Regimen)
Participants received PF-06647020 at 3.2 mg/kg on Days 1 and 15 of each 28-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 17.1 months.
12
Total137

Withdrawals & dropouts

PeriodReasonFG000FG001FG002FG003FG004FG005FG006FG007FG008
Overall StudyDeath0000130002
Overall StudyLost to Follow-up001091000
Overall StudyOther0002102241
Overall StudyParticipant refused further follow-up100160003

Baseline characteristics

CharacteristicTotalPF-06647020 2.8 mg/kg (Q2W Regimen)PF-06647020 2.1 mg/kg (Q2W Regimen)PF-06647020 3.2 mg/kg (Q2W Regimen)PF-06647020 2.1 mg/kg (Q3W Regimen)PF-06647020 1.25 mg/kg (Q3W Regimen)PF-06647020 0.5 mg/kg (Q3W Regimen)PF-06647020 2.8 mg/kg (Q3W Regimen)PF-06647020 3.7 mg/kg (Q3W Regimen)PF-06647020 0.2 mg/kg (Q3W Regimen)
Age, Continuous
Q2W Regimen
65.4 Years
STANDARD_DEVIATION 7.8
65.5 Years
STANDARD_DEVIATION 8.9
64.0 Years
STANDARD_DEVIATION 2.6
65.6 Years
STANDARD_DEVIATION 8
Age, Continuous
Q3W Regimen
58.4 Years
STANDARD_DEVIATION 11.6
55.0 Years
STANDARD_DEVIATION 13.6
61.0 Years
STANDARD_DEVIATION 2.8
57.5 Years
STANDARD_DEVIATION 14.8
58.1 Years
STANDARD_DEVIATION 11.8
59.5 Years
STANDARD_DEVIATION 8.4
73.0 Years
STANDARD_DEVIATION 2.8
Age, Customized
18-44 (Q2W Regimen)
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Age, Customized
18-44 (Q3W Regimen)
16 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants16 Participants0 Participants0 Participants
Age, Customized
< 18 (Q2W Regimen)
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Age, Customized
< 18 (Q3W Regimen)
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Age, Customized
45-64 (Q2W Regimen)
12 Participants5 Participants1 Participants6 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Age, Customized
45-64 (Q3W Regimen)
59 Participants0 Participants0 Participants0 Participants3 Participants2 Participants1 Participants49 Participants4 Participants0 Participants
Age, Customized
>= 65 (Q2W Regimen)
13 Participants5 Participants2 Participants6 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Age, Customized
>= 65 (Q3W Regimen)
37 Participants0 Participants0 Participants0 Participants1 Participants0 Participants1 Participants31 Participants2 Participants2 Participants
Body Mass Index (BMI) Continuous
Q2W Regimen
27.2 kg/m^2
STANDARD_DEVIATION 8.7
29.9 kg/m^2
STANDARD_DEVIATION 9.1
24.9 kg/m^2
STANDARD_DEVIATION 7.1
25.6 kg/m^2
STANDARD_DEVIATION 8.8
Body Mass Index (BMI) Continuous
Q3W Regimen
25.5 kg/m^2
STANDARD_DEVIATION 5.5
27.6 kg/m^2
STANDARD_DEVIATION 7.7
23.6 kg/m^2
STANDARD_DEVIATION 2
22.7 kg/m^2
STANDARD_DEVIATION 2.7
25.6 kg/m^2
STANDARD_DEVIATION 5.5
26.2 kg/m^2
STANDARD_DEVIATION 4.7
18.3 kg/m^2
STANDARD_DEVIATION 2
Race (NIH/OMB)
Q2W Regimen
American Indian or Alaska Native
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Q2W Regimen
Asian
1 Participants0 Participants0 Participants1 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Q2W Regimen
Black or African American
1 Participants1 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Q2W Regimen
More than one race
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Q2W Regimen
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Q2W Regimen
Unknown or Not Reported
2 Participants1 Participants1 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Q2W Regimen
White
21 Participants8 Participants2 Participants11 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Q3W Regimen
American Indian or Alaska Native
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Q3W Regimen
Asian
1 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants1 Participants0 Participants0 Participants
Race (NIH/OMB)
Q3W Regimen
Black or African American
6 Participants0 Participants0 Participants0 Participants1 Participants0 Participants0 Participants5 Participants0 Participants0 Participants
Race (NIH/OMB)
Q3W Regimen
More than one race
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Q3W Regimen
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Q3W Regimen
Unknown or Not Reported
2 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants2 Participants0 Participants0 Participants
Race (NIH/OMB)
Q3W Regimen
White
103 Participants0 Participants0 Participants0 Participants3 Participants2 Participants2 Participants88 Participants6 Participants2 Participants
Sex: Female, Male
Q2W Regimen
Female
24 Participants10 Participants3 Participants11 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Sex: Female, Male
Q2W Regimen
Male
1 Participants0 Participants0 Participants1 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Sex: Female, Male
Q3W Regimen
Female
92 Participants0 Participants0 Participants0 Participants3 Participants1 Participants1 Participants80 Participants5 Participants2 Participants
Sex: Female, Male
Q3W Regimen
Male
20 Participants0 Participants0 Participants0 Participants1 Participants1 Participants1 Participants16 Participants1 Participants0 Participants
Weight Continuous
Q2W Regimen
72.3 kilogram (kg)
STANDARD_DEVIATION 23.4
78.1 kilogram (kg)
STANDARD_DEVIATION 25.5
68.4 kilogram (kg)
STANDARD_DEVIATION 23.8
68.3 kilogram (kg)
STANDARD_DEVIATION 22.5
Weight Continuous
Q3W Regimen
70.0 kilogram (kg)
STANDARD_DEVIATION 16.6
80.7 kilogram (kg)
STANDARD_DEVIATION 27.3
68.7 kilogram (kg)
STANDARD_DEVIATION 5.2
68.8 kilogram (kg)
STANDARD_DEVIATION 21.9
69.9 kilogram (kg)
STANDARD_DEVIATION 16.4
72.2 kilogram (kg)
STANDARD_DEVIATION 14.2
49.2 kilogram (kg)
STANDARD_DEVIATION 10.2

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
EG004
affected / at risk
EG005
affected / at risk
EG006
affected / at risk
EG007
affected / at risk
EG008
affected / at risk
deaths
Total, all-cause mortality
0 / 20 / 20 / 20 / 413 / 960 / 60 / 30 / 102 / 12
other
Total, other adverse events
2 / 22 / 22 / 24 / 493 / 966 / 63 / 310 / 1012 / 12
serious
Total, serious adverse events
0 / 20 / 20 / 21 / 433 / 962 / 61 / 34 / 107 / 12

Outcome results

Primary

Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q2W Regimen

Participants who experienced chemistry laboratory test abnormalities were summarized according to worst toxicity grade observed for each chemistry laboratory test. Laboratory abnormalities were graded by NCI CTCAE version 4.03. This outcome measure calculated the number of participants with chemistry laboratory abnormalities that were shifted from \<=Grade 2 at baseline to Grade 3 or above, including the following parameters: hypokalemia, hyponatremia, hypomagnesemia, hypoalbuminemia, hypocalcemia, hypophosphatemia, alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase.

Time frame: From baseline to end of treatment (approximately 19 months).

Population: All participants enrolled in Q2W regimen who received at least 1 full or partial dose of study medication and had at least 1 observation of the given chemistry laboratory test.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
PF-06647020 0.2 mg/kg(Q3W Regimen)Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q2W RegimenAlanine aminotransferase0 Participants
PF-06647020 0.2 mg/kg(Q3W Regimen)Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q2W RegimenAspartate aminotransferase0 Participants
PF-06647020 0.2 mg/kg(Q3W Regimen)Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q2W RegimenHypomagnesemia0 Participants
PF-06647020 0.2 mg/kg(Q3W Regimen)Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q2W RegimenAlkaline phosphatase0 Participants
PF-06647020 0.2 mg/kg(Q3W Regimen)Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q2W RegimenHypokalemia0 Participants
PF-06647020 0.2 mg/kg(Q3W Regimen)Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q2W RegimenHypoalbuminemia0 Participants
PF-06647020 0.2 mg/kg(Q3W Regimen)Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q2W RegimenHypocalcemia1 Participants
PF-06647020 0.2 mg/kg(Q3W Regimen)Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q2W RegimenHyponatremia0 Participants
PF-06647020 0.2 mg/kg(Q3W Regimen)Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q2W RegimenHypophosphatemia0 Participants
PF-06647020 0.5 mg/kg (Q3W Regimen)Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q2W RegimenHypocalcemia0 Participants
PF-06647020 0.5 mg/kg (Q3W Regimen)Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q2W RegimenAlanine aminotransferase0 Participants
PF-06647020 0.5 mg/kg (Q3W Regimen)Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q2W RegimenHypokalemia1 Participants
PF-06647020 0.5 mg/kg (Q3W Regimen)Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q2W RegimenHypophosphatemia1 Participants
PF-06647020 0.5 mg/kg (Q3W Regimen)Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q2W RegimenAspartate aminotransferase0 Participants
PF-06647020 0.5 mg/kg (Q3W Regimen)Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q2W RegimenHypoalbuminemia1 Participants
PF-06647020 0.5 mg/kg (Q3W Regimen)Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q2W RegimenHyponatremia1 Participants
PF-06647020 0.5 mg/kg (Q3W Regimen)Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q2W RegimenAlkaline phosphatase0 Participants
PF-06647020 0.5 mg/kg (Q3W Regimen)Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q2W RegimenHypomagnesemia0 Participants
PF-06647020 1.25 mg/kg (Q3W Regimen)Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q2W RegimenAlkaline phosphatase1 Participants
PF-06647020 1.25 mg/kg (Q3W Regimen)Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q2W RegimenHypokalemia2 Participants
PF-06647020 1.25 mg/kg (Q3W Regimen)Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q2W RegimenHyponatremia2 Participants
PF-06647020 1.25 mg/kg (Q3W Regimen)Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q2W RegimenHypomagnesemia2 Participants
PF-06647020 1.25 mg/kg (Q3W Regimen)Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q2W RegimenHypocalcemia1 Participants
PF-06647020 1.25 mg/kg (Q3W Regimen)Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q2W RegimenHypophosphatemia0 Participants
PF-06647020 1.25 mg/kg (Q3W Regimen)Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q2W RegimenAlanine aminotransferase1 Participants
PF-06647020 1.25 mg/kg (Q3W Regimen)Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q2W RegimenAspartate aminotransferase1 Participants
PF-06647020 1.25 mg/kg (Q3W Regimen)Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q2W RegimenHypoalbuminemia1 Participants
Primary

Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q3W Regimen

Participants who experienced chemistry laboratory test abnormalities were summarized according to worst toxicity grade observed for each chemistry laboratory test. Laboratory abnormalities were graded by NCI CTCAE version 4.03. This outcome measure calculated the number of participants with chemistry laboratory abnormalities that were shifted from \<=Grade 2 at baseline to Grade 3 or above, including the following parameters: hypokalemia, hypophosphatemia, aspartate aminotransferase, hyperglycemia, alkaline phosphatase, hyponatremia, alanine aminotransferase, hypoalbuminemia, total bilirubin, hypercalcemia, hypomagnesemia , creatinine, gamma glutamyl transferase, hypocalcemia.

Time frame: From baseline to end of treatment (approximately 32 months).

Population: All participants enrolled in Q3W who received at least 1 full or partial dose of study medication and had at least 1 observation of the given chemistry laboratory test.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
PF-06647020 0.2 mg/kg(Q3W Regimen)Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q3W RegimenAlkaline phosphatase0 Participants
PF-06647020 0.2 mg/kg(Q3W Regimen)Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q3W RegimenHyperglycemia0 Participants
PF-06647020 0.2 mg/kg(Q3W Regimen)Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q3W RegimenAspartate aminotransferase0 Participants
PF-06647020 0.2 mg/kg(Q3W Regimen)Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q3W RegimenCreatinine0 Participants
PF-06647020 0.2 mg/kg(Q3W Regimen)Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q3W RegimenHypercalcemia0 Participants
PF-06647020 0.2 mg/kg(Q3W Regimen)Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q3W RegimenTotal bilirubin0 Participants
PF-06647020 0.2 mg/kg(Q3W Regimen)Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q3W RegimenGamma glutamyl transferase0 Participants
PF-06647020 0.2 mg/kg(Q3W Regimen)Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q3W RegimenHypoalbuminemia0 Participants
PF-06647020 0.2 mg/kg(Q3W Regimen)Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q3W RegimenHypocalcemia0 Participants
PF-06647020 0.2 mg/kg(Q3W Regimen)Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q3W RegimenHypomagnesemia0 Participants
PF-06647020 0.2 mg/kg(Q3W Regimen)Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q3W RegimenAlanine aminotransferase0 Participants
PF-06647020 0.2 mg/kg(Q3W Regimen)Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q3W RegimenHyponatremia1 Participants
PF-06647020 0.2 mg/kg(Q3W Regimen)Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q3W RegimenHypokalemia0 Participants
PF-06647020 0.2 mg/kg(Q3W Regimen)Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q3W RegimenHypophosphatemia0 Participants
PF-06647020 0.5 mg/kg (Q3W Regimen)Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q3W RegimenHypercalcemia0 Participants
PF-06647020 0.5 mg/kg (Q3W Regimen)Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q3W RegimenHyperglycemia0 Participants
PF-06647020 0.5 mg/kg (Q3W Regimen)Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q3W RegimenAlanine aminotransferase0 Participants
PF-06647020 0.5 mg/kg (Q3W Regimen)Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q3W RegimenHypophosphatemia0 Participants
PF-06647020 0.5 mg/kg (Q3W Regimen)Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q3W RegimenAspartate aminotransferase0 Participants
PF-06647020 0.5 mg/kg (Q3W Regimen)Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q3W RegimenCreatinine0 Participants
PF-06647020 0.5 mg/kg (Q3W Regimen)Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q3W RegimenHypocalcemia0 Participants
PF-06647020 0.5 mg/kg (Q3W Regimen)Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q3W RegimenHypokalemia0 Participants
PF-06647020 0.5 mg/kg (Q3W Regimen)Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q3W RegimenTotal bilirubin0 Participants
PF-06647020 0.5 mg/kg (Q3W Regimen)Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q3W RegimenAlkaline phosphatase0 Participants
PF-06647020 0.5 mg/kg (Q3W Regimen)Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q3W RegimenHyponatremia0 Participants
PF-06647020 0.5 mg/kg (Q3W Regimen)Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q3W RegimenGamma glutamyl transferase0 Participants
PF-06647020 0.5 mg/kg (Q3W Regimen)Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q3W RegimenHypomagnesemia0 Participants
PF-06647020 0.5 mg/kg (Q3W Regimen)Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q3W RegimenHypoalbuminemia0 Participants
PF-06647020 1.25 mg/kg (Q3W Regimen)Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q3W RegimenHypercalcemia0 Participants
PF-06647020 1.25 mg/kg (Q3W Regimen)Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q3W RegimenCreatinine0 Participants
PF-06647020 1.25 mg/kg (Q3W Regimen)Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q3W RegimenGamma glutamyl transferase0 Participants
PF-06647020 1.25 mg/kg (Q3W Regimen)Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q3W RegimenHypocalcemia0 Participants
PF-06647020 1.25 mg/kg (Q3W Regimen)Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q3W RegimenHypophosphatemia0 Participants
PF-06647020 1.25 mg/kg (Q3W Regimen)Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q3W RegimenAspartate aminotransferase0 Participants
PF-06647020 1.25 mg/kg (Q3W Regimen)Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q3W RegimenHyperglycemia0 Participants
PF-06647020 1.25 mg/kg (Q3W Regimen)Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q3W RegimenAlkaline phosphatase0 Participants
PF-06647020 1.25 mg/kg (Q3W Regimen)Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q3W RegimenHyponatremia0 Participants
PF-06647020 1.25 mg/kg (Q3W Regimen)Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q3W RegimenAlanine aminotransferase0 Participants
PF-06647020 1.25 mg/kg (Q3W Regimen)Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q3W RegimenHypoalbuminemia0 Participants
PF-06647020 1.25 mg/kg (Q3W Regimen)Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q3W RegimenTotal bilirubin0 Participants
PF-06647020 1.25 mg/kg (Q3W Regimen)Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q3W RegimenHypokalemia0 Participants
PF-06647020 1.25 mg/kg (Q3W Regimen)Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q3W RegimenHypomagnesemia0 Participants
PF-06647020 2.1 mg/kg (Q3W Regimen)Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q3W RegimenAlanine aminotransferase0 Participants
PF-06647020 2.1 mg/kg (Q3W Regimen)Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q3W RegimenAlkaline phosphatase0 Participants
PF-06647020 2.1 mg/kg (Q3W Regimen)Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q3W RegimenCreatinine0 Participants
PF-06647020 2.1 mg/kg (Q3W Regimen)Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q3W RegimenHypophosphatemia0 Participants
PF-06647020 2.1 mg/kg (Q3W Regimen)Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q3W RegimenGamma glutamyl transferase0 Participants
PF-06647020 2.1 mg/kg (Q3W Regimen)Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q3W RegimenHypomagnesemia0 Participants
PF-06647020 2.1 mg/kg (Q3W Regimen)Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q3W RegimenHypoalbuminemia0 Participants
PF-06647020 2.1 mg/kg (Q3W Regimen)Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q3W RegimenHyponatremia0 Participants
PF-06647020 2.1 mg/kg (Q3W Regimen)Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q3W RegimenTotal bilirubin0 Participants
PF-06647020 2.1 mg/kg (Q3W Regimen)Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q3W RegimenHyperglycemia0 Participants
PF-06647020 2.1 mg/kg (Q3W Regimen)Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q3W RegimenAspartate aminotransferase0 Participants
PF-06647020 2.1 mg/kg (Q3W Regimen)Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q3W RegimenHypocalcemia0 Participants
PF-06647020 2.1 mg/kg (Q3W Regimen)Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q3W RegimenHypercalcemia0 Participants
PF-06647020 2.1 mg/kg (Q3W Regimen)Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q3W RegimenHypokalemia0 Participants
PF-06647020 2.8 mg/kg (Q3W Regimen)Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q3W RegimenHypophosphatemia8 Participants
PF-06647020 2.8 mg/kg (Q3W Regimen)Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q3W RegimenAspartate aminotransferase6 Participants
PF-06647020 2.8 mg/kg (Q3W Regimen)Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q3W RegimenAlkaline phosphatase6 Participants
PF-06647020 2.8 mg/kg (Q3W Regimen)Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q3W RegimenHypocalcemia1 Participants
PF-06647020 2.8 mg/kg (Q3W Regimen)Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q3W RegimenHypokalemia8 Participants
PF-06647020 2.8 mg/kg (Q3W Regimen)Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q3W RegimenHyponatremia4 Participants
PF-06647020 2.8 mg/kg (Q3W Regimen)Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q3W RegimenAlanine aminotransferase4 Participants
PF-06647020 2.8 mg/kg (Q3W Regimen)Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q3W RegimenGamma glutamyl transferase1 Participants
PF-06647020 2.8 mg/kg (Q3W Regimen)Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q3W RegimenHypoalbuminemia3 Participants
PF-06647020 2.8 mg/kg (Q3W Regimen)Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q3W RegimenCreatinine1 Participants
PF-06647020 2.8 mg/kg (Q3W Regimen)Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q3W RegimenHypomagnesemia2 Participants
PF-06647020 2.8 mg/kg (Q3W Regimen)Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q3W RegimenTotal bilirubin2 Participants
PF-06647020 2.8 mg/kg (Q3W Regimen)Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q3W RegimenHypercalcemia2 Participants
PF-06647020 2.8 mg/kg (Q3W Regimen)Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q3W RegimenHyperglycemia6 Participants
PF-06647020 3.7 mg/kg (Q3W Regimen)Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q3W RegimenTotal bilirubin0 Participants
PF-06647020 3.7 mg/kg (Q3W Regimen)Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q3W RegimenAlanine aminotransferase0 Participants
PF-06647020 3.7 mg/kg (Q3W Regimen)Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q3W RegimenAspartate aminotransferase0 Participants
PF-06647020 3.7 mg/kg (Q3W Regimen)Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q3W RegimenHypomagnesemia0 Participants
PF-06647020 3.7 mg/kg (Q3W Regimen)Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q3W RegimenGamma glutamyl transferase0 Participants
PF-06647020 3.7 mg/kg (Q3W Regimen)Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q3W RegimenHyperglycemia0 Participants
PF-06647020 3.7 mg/kg (Q3W Regimen)Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q3W RegimenHyponatremia0 Participants
PF-06647020 3.7 mg/kg (Q3W Regimen)Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q3W RegimenHypophosphatemia1 Participants
PF-06647020 3.7 mg/kg (Q3W Regimen)Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q3W RegimenHypokalemia1 Participants
PF-06647020 3.7 mg/kg (Q3W Regimen)Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q3W RegimenCreatinine0 Participants
PF-06647020 3.7 mg/kg (Q3W Regimen)Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q3W RegimenHypercalcemia0 Participants
PF-06647020 3.7 mg/kg (Q3W Regimen)Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q3W RegimenHypocalcemia0 Participants
PF-06647020 3.7 mg/kg (Q3W Regimen)Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q3W RegimenHypoalbuminemia0 Participants
PF-06647020 3.7 mg/kg (Q3W Regimen)Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q3W RegimenAlkaline phosphatase0 Participants
Primary

Number of Participants With Coagulation Laboratory Abnormalities (All Cycles) - Q2W Regimen

Participants who experienced coagulation laboratory test abnormalities were summarized according to worst toxicity grade observed for each urinalysis laboratory test. Laboratory abnormalities were graded by NCI CTCAE version 4.03. This outcome measure calculated the number of participants with coagulation laboratory abnormalities that were shifted from \<=Grade 2 at baseline to Grade 3 or above, including the following parameter: prothrombin time international normalized ratio.

Time frame: From baseline to end of treatment (approximately 19 months).

Population: All participants enrolled in Q2W regimen who received at least 1 full or partial dose of study medication and had at least 1 observation of the given coagulation laboratory test.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
PF-06647020 0.2 mg/kg(Q3W Regimen)Number of Participants With Coagulation Laboratory Abnormalities (All Cycles) - Q2W Regimen0 Participants
PF-06647020 0.5 mg/kg (Q3W Regimen)Number of Participants With Coagulation Laboratory Abnormalities (All Cycles) - Q2W Regimen0 Participants
PF-06647020 1.25 mg/kg (Q3W Regimen)Number of Participants With Coagulation Laboratory Abnormalities (All Cycles) - Q2W Regimen1 Participants
Primary

Number of Participants With Coagulation Laboratory Abnormalities (All Cycles) - Q3W Regimen

Participants who experienced coagulation laboratory test abnormalities were summarized according to worst toxicity grade observed for each coagulation laboratory test. Laboratory abnormalities were graded by NCI CTCAE version 4.03. This outcome measure calculated the number of participants with coagulation laboratory abnormalities that were shifted from \<=Grade 2 at baseline to Grade 3 or above, including the following parameter: partial thromboplastin time.

Time frame: From baseline to end of treatment (approximately 32 months).

Population: All participants enrolled in Q3W regimen who received at least 1 full or partial dose of study medication and had at least 1 observation of the given coagulation laboratory test.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
PF-06647020 0.2 mg/kg(Q3W Regimen)Number of Participants With Coagulation Laboratory Abnormalities (All Cycles) - Q3W Regimen0 Participants
PF-06647020 0.5 mg/kg (Q3W Regimen)Number of Participants With Coagulation Laboratory Abnormalities (All Cycles) - Q3W Regimen0 Participants
PF-06647020 1.25 mg/kg (Q3W Regimen)Number of Participants With Coagulation Laboratory Abnormalities (All Cycles) - Q3W Regimen0 Participants
PF-06647020 2.1 mg/kg (Q3W Regimen)Number of Participants With Coagulation Laboratory Abnormalities (All Cycles) - Q3W Regimen0 Participants
PF-06647020 2.8 mg/kg (Q3W Regimen)Number of Participants With Coagulation Laboratory Abnormalities (All Cycles) - Q3W Regimen1 Participants
PF-06647020 3.7 mg/kg (Q3W Regimen)Number of Participants With Coagulation Laboratory Abnormalities (All Cycles) - Q3W Regimen0 Participants
Primary

Number of Participants With DLTs - Q2W Regimen

A DLT was any of the following AEs in the first cycle of treatment (within 28 days of first dose or until participant received second infusion if there were treatment delayed) in the single agent dose escalation. (1)Hematologic: including Grade 4 neutropenia lasting \>7 days; Febrile neutropenia; Grade \>=3 neutropenic infection; Grade 4 thrombocytopenia; treatment delay \>14 days because of hematologic AE; (2) Hepatic: including Grade\>=3 serum bilirubin, hepatic transaminase or alkaline phosphatase; ALT or AST\>=3.0 x ULN concurrent with elevation in bilirubin\>=2.0 x ULN; (3) Grade \>=3 non-hematologic, non-hepatic major organ toxicities; delayed by \>2 weeks in receiving the next scheduled cycle due to persisting toxicities attributable to PF-06647020. Grade \>=3 headache lasting \>48 hours in presence of supportive care. A participant was on study for at least 28 days to be evaluable for DLT observation, and could be replaced if they terminated study participation earlier than 28 days.

Time frame: First cycle, Day 1 up to Day 28

Population: All participants enrolled in Q2W regimen who received at least 1 dose of study medication and who did not have major treatment deviations during first cycle with a baseline disease assessment and at least 1 post baseline disease assessment.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
PF-06647020 0.2 mg/kg(Q3W Regimen)Number of Participants With DLTs - Q2W Regimen0 Participants
PF-06647020 0.5 mg/kg (Q3W Regimen)Number of Participants With DLTs - Q2W Regimen1 Participants
PF-06647020 1.25 mg/kg (Q3W Regimen)Number of Participants With DLTs - Q2W Regimen2 Participants
Primary

Number of Participants With Dose Limiting Toxicities (DLTs) - Q3W Regimen

A DLT was any of the following adverse events(AEs) in the first cycle of treatment (within 21 days of first dose or until participant received second infusion if there were treatment delays). (1)Hematologic: including Grade 4 neutropenia lasting \>7 days; Febrile neutropenia; Grade \>=3 neutropenic infection; Grade 4 anemia; Grade \>=3 thrombocytopenia with clinically significant bleeding. (2) Hepatic, including Grade \>=3 serum bilirubin, hepatic transaminase or alkaline phosphatase; alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>=3.0 x upper limit of normal (ULN) concurrent with elevation in bilirubin \>=2.0 x ULN; (3) Grade \>=3 non-hematologic, non-hepatic major organ toxicities; delayed by \>2 weeks in receiving the next scheduled cycle due to persisting toxicities attributable to PF-06647020. A participant was on study for at least 21 days to be evaluable for DLT observation, and could be replaced if they terminated study participation earlier than 21 days.

Time frame: First Cycle, Day 1 up to Day 21

Population: Participants enrolled in the dose escalation phase in Q3W regimen who received at least 1 dose of study medication and who did not have major treatment deviations during first cycle with a baseline disease assessment and at least 1 post-baseline disease assessment.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
PF-06647020 0.2 mg/kg(Q3W Regimen)Number of Participants With Dose Limiting Toxicities (DLTs) - Q3W Regimen0 Participants
PF-06647020 0.5 mg/kg (Q3W Regimen)Number of Participants With Dose Limiting Toxicities (DLTs) - Q3W Regimen0 Participants
PF-06647020 1.25 mg/kg (Q3W Regimen)Number of Participants With Dose Limiting Toxicities (DLTs) - Q3W Regimen0 Participants
PF-06647020 2.1 mg/kg (Q3W Regimen)Number of Participants With Dose Limiting Toxicities (DLTs) - Q3W Regimen0 Participants
PF-06647020 2.8 mg/kg (Q3W Regimen)Number of Participants With Dose Limiting Toxicities (DLTs) - Q3W Regimen0 Participants
PF-06647020 3.7 mg/kg (Q3W Regimen)Number of Participants With Dose Limiting Toxicities (DLTs) - Q3W Regimen2 Participants
Primary

Number of Participants With Hematology Laboratory Abnormalities (All Cycles) - Q2W Regimen

Participants who experienced hematology laboratory test abnormalities were summarized according to worst toxicity grade observed for each hematology laboratory test. Laboratory abnormalities were graded by NCI CTCAE version 4.03. This outcome measure calculated the number of participants with hematology laboratory abnormalities that were shifted from \<=Grade 2 at baseline to Grade 3 or above, including the following parameters: absolute neutrophils, lymphopenia, white blood cell, anemia.

Time frame: From baseline to end of treatment (approximately 19 months).

Population: All participants enrolled in Q2W regimen who received at least 1 full or partial dose of study medication and had at least 1 observation of the given hematology laboratory test.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
PF-06647020 0.2 mg/kg(Q3W Regimen)Number of Participants With Hematology Laboratory Abnormalities (All Cycles) - Q2W RegimenAbsolute neutrophils0 Participants
PF-06647020 0.2 mg/kg(Q3W Regimen)Number of Participants With Hematology Laboratory Abnormalities (All Cycles) - Q2W RegimenLymphopenia0 Participants
PF-06647020 0.2 mg/kg(Q3W Regimen)Number of Participants With Hematology Laboratory Abnormalities (All Cycles) - Q2W RegimenWhite blood cells0 Participants
PF-06647020 0.2 mg/kg(Q3W Regimen)Number of Participants With Hematology Laboratory Abnormalities (All Cycles) - Q2W RegimenAnemia0 Participants
PF-06647020 0.5 mg/kg (Q3W Regimen)Number of Participants With Hematology Laboratory Abnormalities (All Cycles) - Q2W RegimenAnemia0 Participants
PF-06647020 0.5 mg/kg (Q3W Regimen)Number of Participants With Hematology Laboratory Abnormalities (All Cycles) - Q2W RegimenAbsolute neutrophils3 Participants
PF-06647020 0.5 mg/kg (Q3W Regimen)Number of Participants With Hematology Laboratory Abnormalities (All Cycles) - Q2W RegimenWhite blood cells2 Participants
PF-06647020 0.5 mg/kg (Q3W Regimen)Number of Participants With Hematology Laboratory Abnormalities (All Cycles) - Q2W RegimenLymphopenia0 Participants
PF-06647020 1.25 mg/kg (Q3W Regimen)Number of Participants With Hematology Laboratory Abnormalities (All Cycles) - Q2W RegimenAnemia1 Participants
PF-06647020 1.25 mg/kg (Q3W Regimen)Number of Participants With Hematology Laboratory Abnormalities (All Cycles) - Q2W RegimenLymphopenia4 Participants
PF-06647020 1.25 mg/kg (Q3W Regimen)Number of Participants With Hematology Laboratory Abnormalities (All Cycles) - Q2W RegimenWhite blood cells2 Participants
PF-06647020 1.25 mg/kg (Q3W Regimen)Number of Participants With Hematology Laboratory Abnormalities (All Cycles) - Q2W RegimenAbsolute neutrophils5 Participants
Primary

Number of Participants With Hematology Laboratory Abnormalities (All Cycles) - Q3W Regimen

Participants who experienced hematology laboratory test abnormalities were summarized according to worst toxicity grade observed for each hematology laboratory test. Laboratory abnormalities were graded by NCI CTCAE version 4.03. This outcome measure calculated the number of participants with hematology laboratory abnormalities that were shifted from \<=Grade 2 at baseline to Grade 3 or above, including the following parameters: absolute neutrophils, lymphopenia, white blood cell, anemia, platelets.

Time frame: From baseline to end of treatment (approximately 32 months).

Population: All participants enrolled in Q3W regimen who received at least 1 full or partial dose of study medication and had at least 1 observation of the given hematology laboratory test.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
PF-06647020 0.2 mg/kg(Q3W Regimen)Number of Participants With Hematology Laboratory Abnormalities (All Cycles) - Q3W RegimenPlatelets0 Participants
PF-06647020 0.2 mg/kg(Q3W Regimen)Number of Participants With Hematology Laboratory Abnormalities (All Cycles) - Q3W RegimenWhite blood cells0 Participants
PF-06647020 0.2 mg/kg(Q3W Regimen)Number of Participants With Hematology Laboratory Abnormalities (All Cycles) - Q3W RegimenAnemia0 Participants
PF-06647020 0.2 mg/kg(Q3W Regimen)Number of Participants With Hematology Laboratory Abnormalities (All Cycles) - Q3W RegimenLymphopenia1 Participants
PF-06647020 0.2 mg/kg(Q3W Regimen)Number of Participants With Hematology Laboratory Abnormalities (All Cycles) - Q3W RegimenAbsolute neutrophils0 Participants
PF-06647020 0.5 mg/kg (Q3W Regimen)Number of Participants With Hematology Laboratory Abnormalities (All Cycles) - Q3W RegimenPlatelets0 Participants
PF-06647020 0.5 mg/kg (Q3W Regimen)Number of Participants With Hematology Laboratory Abnormalities (All Cycles) - Q3W RegimenAbsolute neutrophils0 Participants
PF-06647020 0.5 mg/kg (Q3W Regimen)Number of Participants With Hematology Laboratory Abnormalities (All Cycles) - Q3W RegimenLymphopenia1 Participants
PF-06647020 0.5 mg/kg (Q3W Regimen)Number of Participants With Hematology Laboratory Abnormalities (All Cycles) - Q3W RegimenWhite blood cells0 Participants
PF-06647020 0.5 mg/kg (Q3W Regimen)Number of Participants With Hematology Laboratory Abnormalities (All Cycles) - Q3W RegimenAnemia0 Participants
PF-06647020 1.25 mg/kg (Q3W Regimen)Number of Participants With Hematology Laboratory Abnormalities (All Cycles) - Q3W RegimenPlatelets0 Participants
PF-06647020 1.25 mg/kg (Q3W Regimen)Number of Participants With Hematology Laboratory Abnormalities (All Cycles) - Q3W RegimenWhite blood cells0 Participants
PF-06647020 1.25 mg/kg (Q3W Regimen)Number of Participants With Hematology Laboratory Abnormalities (All Cycles) - Q3W RegimenLymphopenia0 Participants
PF-06647020 1.25 mg/kg (Q3W Regimen)Number of Participants With Hematology Laboratory Abnormalities (All Cycles) - Q3W RegimenAbsolute neutrophils0 Participants
PF-06647020 1.25 mg/kg (Q3W Regimen)Number of Participants With Hematology Laboratory Abnormalities (All Cycles) - Q3W RegimenAnemia0 Participants
PF-06647020 2.1 mg/kg (Q3W Regimen)Number of Participants With Hematology Laboratory Abnormalities (All Cycles) - Q3W RegimenWhite blood cells0 Participants
PF-06647020 2.1 mg/kg (Q3W Regimen)Number of Participants With Hematology Laboratory Abnormalities (All Cycles) - Q3W RegimenLymphopenia0 Participants
PF-06647020 2.1 mg/kg (Q3W Regimen)Number of Participants With Hematology Laboratory Abnormalities (All Cycles) - Q3W RegimenPlatelets0 Participants
PF-06647020 2.1 mg/kg (Q3W Regimen)Number of Participants With Hematology Laboratory Abnormalities (All Cycles) - Q3W RegimenAnemia0 Participants
PF-06647020 2.1 mg/kg (Q3W Regimen)Number of Participants With Hematology Laboratory Abnormalities (All Cycles) - Q3W RegimenAbsolute neutrophils1 Participants
PF-06647020 2.8 mg/kg (Q3W Regimen)Number of Participants With Hematology Laboratory Abnormalities (All Cycles) - Q3W RegimenLymphopenia21 Participants
PF-06647020 2.8 mg/kg (Q3W Regimen)Number of Participants With Hematology Laboratory Abnormalities (All Cycles) - Q3W RegimenAbsolute neutrophils28 Participants
PF-06647020 2.8 mg/kg (Q3W Regimen)Number of Participants With Hematology Laboratory Abnormalities (All Cycles) - Q3W RegimenPlatelets2 Participants
PF-06647020 2.8 mg/kg (Q3W Regimen)Number of Participants With Hematology Laboratory Abnormalities (All Cycles) - Q3W RegimenAnemia2 Participants
PF-06647020 2.8 mg/kg (Q3W Regimen)Number of Participants With Hematology Laboratory Abnormalities (All Cycles) - Q3W RegimenWhite blood cells18 Participants
PF-06647020 3.7 mg/kg (Q3W Regimen)Number of Participants With Hematology Laboratory Abnormalities (All Cycles) - Q3W RegimenPlatelets0 Participants
PF-06647020 3.7 mg/kg (Q3W Regimen)Number of Participants With Hematology Laboratory Abnormalities (All Cycles) - Q3W RegimenAbsolute neutrophils2 Participants
PF-06647020 3.7 mg/kg (Q3W Regimen)Number of Participants With Hematology Laboratory Abnormalities (All Cycles) - Q3W RegimenWhite blood cells1 Participants
PF-06647020 3.7 mg/kg (Q3W Regimen)Number of Participants With Hematology Laboratory Abnormalities (All Cycles) - Q3W RegimenAnemia0 Participants
PF-06647020 3.7 mg/kg (Q3W Regimen)Number of Participants With Hematology Laboratory Abnormalities (All Cycles) - Q3W RegimenLymphopenia2 Participants
Primary

Number of Participants With Treatment-Emergent Adverse Events (AEs) - Q3W Regimen (All-Causality)

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent AEs were those with initial onset or increasing in severity after the first dose of study medication.

Time frame: From the time the participant took the first dose of study medication through the participant's last visit. (approximately 32 months)

Population: All participants enrolled in Q3W regimen who received at least 1 full or partial dose of study medication.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
PF-06647020 0.2 mg/kg(Q3W Regimen)Number of Participants With Treatment-Emergent Adverse Events (AEs) - Q3W Regimen (All-Causality)SAEs0 Participants
PF-06647020 0.2 mg/kg(Q3W Regimen)Number of Participants With Treatment-Emergent Adverse Events (AEs) - Q3W Regimen (All-Causality)AEs2 Participants
PF-06647020 0.5 mg/kg (Q3W Regimen)Number of Participants With Treatment-Emergent Adverse Events (AEs) - Q3W Regimen (All-Causality)AEs2 Participants
PF-06647020 0.5 mg/kg (Q3W Regimen)Number of Participants With Treatment-Emergent Adverse Events (AEs) - Q3W Regimen (All-Causality)SAEs0 Participants
PF-06647020 1.25 mg/kg (Q3W Regimen)Number of Participants With Treatment-Emergent Adverse Events (AEs) - Q3W Regimen (All-Causality)AEs2 Participants
PF-06647020 1.25 mg/kg (Q3W Regimen)Number of Participants With Treatment-Emergent Adverse Events (AEs) - Q3W Regimen (All-Causality)SAEs0 Participants
PF-06647020 2.1 mg/kg (Q3W Regimen)Number of Participants With Treatment-Emergent Adverse Events (AEs) - Q3W Regimen (All-Causality)AEs4 Participants
PF-06647020 2.1 mg/kg (Q3W Regimen)Number of Participants With Treatment-Emergent Adverse Events (AEs) - Q3W Regimen (All-Causality)SAEs1 Participants
PF-06647020 2.8 mg/kg (Q3W Regimen)Number of Participants With Treatment-Emergent Adverse Events (AEs) - Q3W Regimen (All-Causality)AEs96 Participants
PF-06647020 2.8 mg/kg (Q3W Regimen)Number of Participants With Treatment-Emergent Adverse Events (AEs) - Q3W Regimen (All-Causality)SAEs33 Participants
PF-06647020 3.7 mg/kg (Q3W Regimen)Number of Participants With Treatment-Emergent Adverse Events (AEs) - Q3W Regimen (All-Causality)SAEs2 Participants
PF-06647020 3.7 mg/kg (Q3W Regimen)Number of Participants With Treatment-Emergent Adverse Events (AEs) - Q3W Regimen (All-Causality)AEs6 Participants
Primary

Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q2W Regimen (All-Causality and Treatment-Related)

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Treatment-emergent AEs were those with initial onset or increasing in severity after the first dose of study medication. All AEs were graded by the investigator according to the NCI CTCAE version 4.03. Grade 1 AEs are mild AEs; Grade 2 AEs are moderate AEs; Grade 3 AEs are severe AEs, Grade 4 AEs are life-threatening consequences and Grade 5 AEs are deaths related to AEs. Each AE was counted once for the participant in the most severe severity.

Time frame: From the time the participant took the first dose of study medication through the participant's last visit. (approximately 19 months)

Population: All participants enrolled in Q2W regimen who received at least 1 full or partial dose of study medication.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
PF-06647020 0.2 mg/kg(Q3W Regimen)Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q2W Regimen (All-Causality and Treatment-Related)Grade 1 (all-causality)0 Participants
PF-06647020 0.2 mg/kg(Q3W Regimen)Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q2W Regimen (All-Causality and Treatment-Related)Grade 3 (treatment-related)0 Participants
PF-06647020 0.2 mg/kg(Q3W Regimen)Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q2W Regimen (All-Causality and Treatment-Related)Grade 3 (all-causality)1 Participants
PF-06647020 0.2 mg/kg(Q3W Regimen)Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q2W Regimen (All-Causality and Treatment-Related)Grade 4 (treatment-related)0 Participants
PF-06647020 0.2 mg/kg(Q3W Regimen)Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q2W Regimen (All-Causality and Treatment-Related)Missing or Unknown (treatment-related)0 Participants
PF-06647020 0.2 mg/kg(Q3W Regimen)Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q2W Regimen (All-Causality and Treatment-Related)Grade 4 (all-causality)0 Participants
PF-06647020 0.2 mg/kg(Q3W Regimen)Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q2W Regimen (All-Causality and Treatment-Related)Grade 5 (all-causality)0 Participants
PF-06647020 0.2 mg/kg(Q3W Regimen)Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q2W Regimen (All-Causality and Treatment-Related)Grade 5 (treatment-related)0 Participants
PF-06647020 0.2 mg/kg(Q3W Regimen)Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q2W Regimen (All-Causality and Treatment-Related)Missing or Unknown (all-causality)0 Participants
PF-06647020 0.2 mg/kg(Q3W Regimen)Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q2W Regimen (All-Causality and Treatment-Related)Grade 2 (all-causality)2 Participants
PF-06647020 0.2 mg/kg(Q3W Regimen)Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q2W Regimen (All-Causality and Treatment-Related)Grade 1 (treatment-related)0 Participants
PF-06647020 0.2 mg/kg(Q3W Regimen)Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q2W Regimen (All-Causality and Treatment-Related)Grade 2 (treatment-related)3 Participants
PF-06647020 0.5 mg/kg (Q3W Regimen)Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q2W Regimen (All-Causality and Treatment-Related)Missing or Unknown (all-causality)0 Participants
PF-06647020 0.5 mg/kg (Q3W Regimen)Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q2W Regimen (All-Causality and Treatment-Related)Grade 2 (all-causality)3 Participants
PF-06647020 0.5 mg/kg (Q3W Regimen)Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q2W Regimen (All-Causality and Treatment-Related)Grade 3 (treatment-related)4 Participants
PF-06647020 0.5 mg/kg (Q3W Regimen)Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q2W Regimen (All-Causality and Treatment-Related)Grade 5 (all-causality)0 Participants
PF-06647020 0.5 mg/kg (Q3W Regimen)Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q2W Regimen (All-Causality and Treatment-Related)Grade 2 (treatment-related)4 Participants
PF-06647020 0.5 mg/kg (Q3W Regimen)Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q2W Regimen (All-Causality and Treatment-Related)Grade 4 (treatment-related)2 Participants
PF-06647020 0.5 mg/kg (Q3W Regimen)Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q2W Regimen (All-Causality and Treatment-Related)Grade 3 (all-causality)5 Participants
PF-06647020 0.5 mg/kg (Q3W Regimen)Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q2W Regimen (All-Causality and Treatment-Related)Grade 5 (treatment-related)0 Participants
PF-06647020 0.5 mg/kg (Q3W Regimen)Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q2W Regimen (All-Causality and Treatment-Related)Grade 1 (all-causality)0 Participants
PF-06647020 0.5 mg/kg (Q3W Regimen)Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q2W Regimen (All-Causality and Treatment-Related)Grade 1 (treatment-related)0 Participants
PF-06647020 0.5 mg/kg (Q3W Regimen)Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q2W Regimen (All-Causality and Treatment-Related)Missing or Unknown (treatment-related)0 Participants
PF-06647020 0.5 mg/kg (Q3W Regimen)Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q2W Regimen (All-Causality and Treatment-Related)Grade 4 (all-causality)2 Participants
PF-06647020 1.25 mg/kg (Q3W Regimen)Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q2W Regimen (All-Causality and Treatment-Related)Missing or Unknown (treatment-related)0 Participants
PF-06647020 1.25 mg/kg (Q3W Regimen)Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q2W Regimen (All-Causality and Treatment-Related)Grade 4 (all-causality)2 Participants
PF-06647020 1.25 mg/kg (Q3W Regimen)Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q2W Regimen (All-Causality and Treatment-Related)Grade 1 (all-causality)0 Participants
PF-06647020 1.25 mg/kg (Q3W Regimen)Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q2W Regimen (All-Causality and Treatment-Related)Grade 2 (all-causality)2 Participants
PF-06647020 1.25 mg/kg (Q3W Regimen)Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q2W Regimen (All-Causality and Treatment-Related)Grade 3 (all-causality)7 Participants
PF-06647020 1.25 mg/kg (Q3W Regimen)Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q2W Regimen (All-Causality and Treatment-Related)Grade 5 (all-causality)1 Participants
PF-06647020 1.25 mg/kg (Q3W Regimen)Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q2W Regimen (All-Causality and Treatment-Related)Missing or Unknown (all-causality)0 Participants
PF-06647020 1.25 mg/kg (Q3W Regimen)Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q2W Regimen (All-Causality and Treatment-Related)Grade 1 (treatment-related)0 Participants
PF-06647020 1.25 mg/kg (Q3W Regimen)Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q2W Regimen (All-Causality and Treatment-Related)Grade 2 (treatment-related)5 Participants
PF-06647020 1.25 mg/kg (Q3W Regimen)Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q2W Regimen (All-Causality and Treatment-Related)Grade 3 (treatment-related)6 Participants
PF-06647020 1.25 mg/kg (Q3W Regimen)Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q2W Regimen (All-Causality and Treatment-Related)Grade 4 (treatment-related)1 Participants
PF-06647020 1.25 mg/kg (Q3W Regimen)Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q2W Regimen (All-Causality and Treatment-Related)Grade 5 (treatment-related)0 Participants
Primary

Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q3W Regimen (All-Causality and Treatment-Related)

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Treatment-emergent AEs were those with initial onset or increasing in severity after the first dose of study medication. All AEs were graded by the investigator according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Grade 1 AEs are mild AEs; Grade 2 AEs are moderate AEs; Grade 3 AEs are severe AEs, Grade 4 AEs are life-threatening consequences and Grade 5 AEs are deaths related to AEs. Each AE was counted once for the participant in the most severe severity.

Time frame: From the time the participant took the first dose of study medication through the participant's last visit. (approximately 32 months)

Population: All participants enrolled in Q3W regimen who received at least 1 full or partial dose of study medication.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
PF-06647020 0.2 mg/kg(Q3W Regimen)Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q3W Regimen (All-Causality and Treatment-Related)Grade 4 (treatment-related)0 Participants
PF-06647020 0.2 mg/kg(Q3W Regimen)Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q3W Regimen (All-Causality and Treatment-Related)Missing or Unknown (all-causality)0 Participants
PF-06647020 0.2 mg/kg(Q3W Regimen)Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q3W Regimen (All-Causality and Treatment-Related)Grade 5 (treatment-related)0 Participants
PF-06647020 0.2 mg/kg(Q3W Regimen)Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q3W Regimen (All-Causality and Treatment-Related)Grade 2 (all-causality)1 Participants
PF-06647020 0.2 mg/kg(Q3W Regimen)Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q3W Regimen (All-Causality and Treatment-Related)Missing or Unknown (treatment-related)0 Participants
PF-06647020 0.2 mg/kg(Q3W Regimen)Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q3W Regimen (All-Causality and Treatment-Related)Grade 3 (all-causality)1 Participants
PF-06647020 0.2 mg/kg(Q3W Regimen)Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q3W Regimen (All-Causality and Treatment-Related)Grade 1 (treatment-related)0 Participants
PF-06647020 0.2 mg/kg(Q3W Regimen)Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q3W Regimen (All-Causality and Treatment-Related)Grade 2 (treatment-related)0 Participants
PF-06647020 0.2 mg/kg(Q3W Regimen)Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q3W Regimen (All-Causality and Treatment-Related)Grade 5 (all-causality)0 Participants
PF-06647020 0.2 mg/kg(Q3W Regimen)Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q3W Regimen (All-Causality and Treatment-Related)Grade 1 (all-causality)0 Participants
PF-06647020 0.2 mg/kg(Q3W Regimen)Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q3W Regimen (All-Causality and Treatment-Related)Grade 3 (treatment-related)1 Participants
PF-06647020 0.2 mg/kg(Q3W Regimen)Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q3W Regimen (All-Causality and Treatment-Related)Grade 4 (all-causality)0 Participants
PF-06647020 0.5 mg/kg (Q3W Regimen)Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q3W Regimen (All-Causality and Treatment-Related)Missing or Unknown (treatment-related)0 Participants
PF-06647020 0.5 mg/kg (Q3W Regimen)Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q3W Regimen (All-Causality and Treatment-Related)Grade 1 (treatment-related)1 Participants
PF-06647020 0.5 mg/kg (Q3W Regimen)Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q3W Regimen (All-Causality and Treatment-Related)Grade 2 (treatment-related)0 Participants
PF-06647020 0.5 mg/kg (Q3W Regimen)Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q3W Regimen (All-Causality and Treatment-Related)Grade 1 (all-causality)0 Participants
PF-06647020 0.5 mg/kg (Q3W Regimen)Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q3W Regimen (All-Causality and Treatment-Related)Grade 5 (treatment-related)0 Participants
PF-06647020 0.5 mg/kg (Q3W Regimen)Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q3W Regimen (All-Causality and Treatment-Related)Grade 2 (all-causality)2 Participants
PF-06647020 0.5 mg/kg (Q3W Regimen)Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q3W Regimen (All-Causality and Treatment-Related)Grade 4 (treatment-related)0 Participants
PF-06647020 0.5 mg/kg (Q3W Regimen)Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q3W Regimen (All-Causality and Treatment-Related)Grade 3 (all-causality)0 Participants
PF-06647020 0.5 mg/kg (Q3W Regimen)Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q3W Regimen (All-Causality and Treatment-Related)Grade 4 (all-causality)0 Participants
PF-06647020 0.5 mg/kg (Q3W Regimen)Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q3W Regimen (All-Causality and Treatment-Related)Grade 5 (all-causality)0 Participants
PF-06647020 0.5 mg/kg (Q3W Regimen)Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q3W Regimen (All-Causality and Treatment-Related)Grade 3 (treatment-related)0 Participants
PF-06647020 0.5 mg/kg (Q3W Regimen)Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q3W Regimen (All-Causality and Treatment-Related)Missing or Unknown (all-causality)0 Participants
PF-06647020 1.25 mg/kg (Q3W Regimen)Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q3W Regimen (All-Causality and Treatment-Related)Grade 3 (all-causality)1 Participants
PF-06647020 1.25 mg/kg (Q3W Regimen)Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q3W Regimen (All-Causality and Treatment-Related)Grade 1 (all-causality)1 Participants
PF-06647020 1.25 mg/kg (Q3W Regimen)Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q3W Regimen (All-Causality and Treatment-Related)Grade 1 (treatment-related)1 Participants
PF-06647020 1.25 mg/kg (Q3W Regimen)Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q3W Regimen (All-Causality and Treatment-Related)Grade 3 (treatment-related)0 Participants
PF-06647020 1.25 mg/kg (Q3W Regimen)Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q3W Regimen (All-Causality and Treatment-Related)Grade 5 (treatment-related)0 Participants
PF-06647020 1.25 mg/kg (Q3W Regimen)Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q3W Regimen (All-Causality and Treatment-Related)Grade 2 (treatment-related)0 Participants
PF-06647020 1.25 mg/kg (Q3W Regimen)Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q3W Regimen (All-Causality and Treatment-Related)Grade 4 (all-causality)0 Participants
PF-06647020 1.25 mg/kg (Q3W Regimen)Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q3W Regimen (All-Causality and Treatment-Related)Grade 4 (treatment-related)0 Participants
PF-06647020 1.25 mg/kg (Q3W Regimen)Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q3W Regimen (All-Causality and Treatment-Related)Grade 5 (all-causality)0 Participants
PF-06647020 1.25 mg/kg (Q3W Regimen)Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q3W Regimen (All-Causality and Treatment-Related)Grade 2 (all-causality)0 Participants
PF-06647020 1.25 mg/kg (Q3W Regimen)Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q3W Regimen (All-Causality and Treatment-Related)Missing or Unknown (all-causality)0 Participants
PF-06647020 1.25 mg/kg (Q3W Regimen)Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q3W Regimen (All-Causality and Treatment-Related)Missing or Unknown (treatment-related)0 Participants
PF-06647020 2.1 mg/kg (Q3W Regimen)Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q3W Regimen (All-Causality and Treatment-Related)Grade 3 (treatment-related)0 Participants
PF-06647020 2.1 mg/kg (Q3W Regimen)Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q3W Regimen (All-Causality and Treatment-Related)Grade 3 (all-causality)1 Participants
PF-06647020 2.1 mg/kg (Q3W Regimen)Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q3W Regimen (All-Causality and Treatment-Related)Grade 4 (all-causality)0 Participants
PF-06647020 2.1 mg/kg (Q3W Regimen)Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q3W Regimen (All-Causality and Treatment-Related)Grade 5 (all-causality)0 Participants
PF-06647020 2.1 mg/kg (Q3W Regimen)Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q3W Regimen (All-Causality and Treatment-Related)Grade 1 (all-causality)1 Participants
PF-06647020 2.1 mg/kg (Q3W Regimen)Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q3W Regimen (All-Causality and Treatment-Related)Grade 2 (all-causality)2 Participants
PF-06647020 2.1 mg/kg (Q3W Regimen)Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q3W Regimen (All-Causality and Treatment-Related)Missing or Unknown (all-causality)0 Participants
PF-06647020 2.1 mg/kg (Q3W Regimen)Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q3W Regimen (All-Causality and Treatment-Related)Grade 1 (treatment-related)1 Participants
PF-06647020 2.1 mg/kg (Q3W Regimen)Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q3W Regimen (All-Causality and Treatment-Related)Grade 2 (treatment-related)3 Participants
PF-06647020 2.1 mg/kg (Q3W Regimen)Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q3W Regimen (All-Causality and Treatment-Related)Grade 4 (treatment-related)0 Participants
PF-06647020 2.1 mg/kg (Q3W Regimen)Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q3W Regimen (All-Causality and Treatment-Related)Grade 5 (treatment-related)0 Participants
PF-06647020 2.1 mg/kg (Q3W Regimen)Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q3W Regimen (All-Causality and Treatment-Related)Missing or Unknown (treatment-related)0 Participants
PF-06647020 2.8 mg/kg (Q3W Regimen)Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q3W Regimen (All-Causality and Treatment-Related)Grade 2 (treatment-related)21 Participants
PF-06647020 2.8 mg/kg (Q3W Regimen)Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q3W Regimen (All-Causality and Treatment-Related)Missing or Unknown (all-causality)0 Participants
PF-06647020 2.8 mg/kg (Q3W Regimen)Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q3W Regimen (All-Causality and Treatment-Related)Grade 3 (all-causality)49 Participants
PF-06647020 2.8 mg/kg (Q3W Regimen)Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q3W Regimen (All-Causality and Treatment-Related)Grade 2 (all-causality)18 Participants
PF-06647020 2.8 mg/kg (Q3W Regimen)Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q3W Regimen (All-Causality and Treatment-Related)Grade 4 (treatment-related)12 Participants
PF-06647020 2.8 mg/kg (Q3W Regimen)Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q3W Regimen (All-Causality and Treatment-Related)Grade 1 (all-causality)6 Participants
PF-06647020 2.8 mg/kg (Q3W Regimen)Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q3W Regimen (All-Causality and Treatment-Related)Missing or Unknown (treatment-related)0 Participants
PF-06647020 2.8 mg/kg (Q3W Regimen)Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q3W Regimen (All-Causality and Treatment-Related)Grade 5 (treatment-related)0 Participants
PF-06647020 2.8 mg/kg (Q3W Regimen)Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q3W Regimen (All-Causality and Treatment-Related)Grade 3 (treatment-related)28 Participants
PF-06647020 2.8 mg/kg (Q3W Regimen)Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q3W Regimen (All-Causality and Treatment-Related)Grade 5 (all-causality)9 Participants
PF-06647020 2.8 mg/kg (Q3W Regimen)Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q3W Regimen (All-Causality and Treatment-Related)Grade 1 (treatment-related)23 Participants
PF-06647020 2.8 mg/kg (Q3W Regimen)Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q3W Regimen (All-Causality and Treatment-Related)Grade 4 (all-causality)14 Participants
PF-06647020 3.7 mg/kg (Q3W Regimen)Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q3W Regimen (All-Causality and Treatment-Related)Grade 1 (all-causality)0 Participants
PF-06647020 3.7 mg/kg (Q3W Regimen)Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q3W Regimen (All-Causality and Treatment-Related)Grade 2 (treatment-related)1 Participants
PF-06647020 3.7 mg/kg (Q3W Regimen)Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q3W Regimen (All-Causality and Treatment-Related)Grade 5 (treatment-related)0 Participants
PF-06647020 3.7 mg/kg (Q3W Regimen)Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q3W Regimen (All-Causality and Treatment-Related)Grade 5 (all-causality)0 Participants
PF-06647020 3.7 mg/kg (Q3W Regimen)Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q3W Regimen (All-Causality and Treatment-Related)Grade 4 (all-causality)0 Participants
PF-06647020 3.7 mg/kg (Q3W Regimen)Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q3W Regimen (All-Causality and Treatment-Related)Grade 3 (all-causality)5 Participants
PF-06647020 3.7 mg/kg (Q3W Regimen)Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q3W Regimen (All-Causality and Treatment-Related)Grade 3 (treatment-related)3 Participants
PF-06647020 3.7 mg/kg (Q3W Regimen)Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q3W Regimen (All-Causality and Treatment-Related)Grade 2 (all-causality)1 Participants
PF-06647020 3.7 mg/kg (Q3W Regimen)Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q3W Regimen (All-Causality and Treatment-Related)Grade 1 (treatment-related)1 Participants
PF-06647020 3.7 mg/kg (Q3W Regimen)Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q3W Regimen (All-Causality and Treatment-Related)Missing or Unknown (treatment-related)0 Participants
PF-06647020 3.7 mg/kg (Q3W Regimen)Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q3W Regimen (All-Causality and Treatment-Related)Missing or Unknown (all-causality)0 Participants
PF-06647020 3.7 mg/kg (Q3W Regimen)Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q3W Regimen (All-Causality and Treatment-Related)Grade 4 (treatment-related)0 Participants
Primary

Number of Participants With Treatment-Emergent AEs - Q2W Regimen (All-Causality)

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent AEs were those with initial onset or increasing in severity after the first dose of study medication.

Time frame: From the time the participant took the first dose of study medication through the participant's last visit. (approximately 19 months)

Population: All participants enrolled in Q2W regimen who received at least 1 full or partial dose of study medication.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
PF-06647020 0.2 mg/kg(Q3W Regimen)Number of Participants With Treatment-Emergent AEs - Q2W Regimen (All-Causality)AEs3 Participants
PF-06647020 0.2 mg/kg(Q3W Regimen)Number of Participants With Treatment-Emergent AEs - Q2W Regimen (All-Causality)SAEs1 Participants
PF-06647020 0.5 mg/kg (Q3W Regimen)Number of Participants With Treatment-Emergent AEs - Q2W Regimen (All-Causality)AEs10 Participants
PF-06647020 0.5 mg/kg (Q3W Regimen)Number of Participants With Treatment-Emergent AEs - Q2W Regimen (All-Causality)SAEs4 Participants
PF-06647020 1.25 mg/kg (Q3W Regimen)Number of Participants With Treatment-Emergent AEs - Q2W Regimen (All-Causality)AEs12 Participants
PF-06647020 1.25 mg/kg (Q3W Regimen)Number of Participants With Treatment-Emergent AEs - Q2W Regimen (All-Causality)SAEs7 Participants
Primary

Number of Participants With Treatment-Emergent AEs - Q2W Regimen (Treatment-Related)

A treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent AEs were those with initial onset or increasing in severity after the first dose of study medication.

Time frame: From the time the participant took the first dose of study medication through the participant's last visit. (approximately 19 months)

Population: All participants enrolled in Q2W regimen who received at least 1 full or partial dose of study medication.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
PF-06647020 0.2 mg/kg(Q3W Regimen)Number of Participants With Treatment-Emergent AEs - Q2W Regimen (Treatment-Related)AEs3 Participants
PF-06647020 0.2 mg/kg(Q3W Regimen)Number of Participants With Treatment-Emergent AEs - Q2W Regimen (Treatment-Related)SAEs0 Participants
PF-06647020 0.5 mg/kg (Q3W Regimen)Number of Participants With Treatment-Emergent AEs - Q2W Regimen (Treatment-Related)AEs10 Participants
PF-06647020 0.5 mg/kg (Q3W Regimen)Number of Participants With Treatment-Emergent AEs - Q2W Regimen (Treatment-Related)SAEs2 Participants
PF-06647020 1.25 mg/kg (Q3W Regimen)Number of Participants With Treatment-Emergent AEs - Q2W Regimen (Treatment-Related)AEs12 Participants
PF-06647020 1.25 mg/kg (Q3W Regimen)Number of Participants With Treatment-Emergent AEs - Q2W Regimen (Treatment-Related)SAEs2 Participants
Primary

Number of Participants With Treatment-Emergent AEs - Q3W Regimen (Treatment-Related)

A treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent AEs were those with initial onset or increasing in severity after the first dose of study medication.

Time frame: From the time the participant took the first dose of study medication through the participant's last visit. (approximately 32 months)

Population: All participants enrolled in Q3W regimen who received at least 1 full or partial dose of study medication.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
PF-06647020 0.2 mg/kg(Q3W Regimen)Number of Participants With Treatment-Emergent AEs - Q3W Regimen (Treatment-Related)AEs1 Participants
PF-06647020 0.2 mg/kg(Q3W Regimen)Number of Participants With Treatment-Emergent AEs - Q3W Regimen (Treatment-Related)SAEs0 Participants
PF-06647020 0.5 mg/kg (Q3W Regimen)Number of Participants With Treatment-Emergent AEs - Q3W Regimen (Treatment-Related)AEs1 Participants
PF-06647020 0.5 mg/kg (Q3W Regimen)Number of Participants With Treatment-Emergent AEs - Q3W Regimen (Treatment-Related)SAEs0 Participants
PF-06647020 1.25 mg/kg (Q3W Regimen)Number of Participants With Treatment-Emergent AEs - Q3W Regimen (Treatment-Related)SAEs0 Participants
PF-06647020 1.25 mg/kg (Q3W Regimen)Number of Participants With Treatment-Emergent AEs - Q3W Regimen (Treatment-Related)AEs1 Participants
PF-06647020 2.1 mg/kg (Q3W Regimen)Number of Participants With Treatment-Emergent AEs - Q3W Regimen (Treatment-Related)AEs4 Participants
PF-06647020 2.1 mg/kg (Q3W Regimen)Number of Participants With Treatment-Emergent AEs - Q3W Regimen (Treatment-Related)SAEs1 Participants
PF-06647020 2.8 mg/kg (Q3W Regimen)Number of Participants With Treatment-Emergent AEs - Q3W Regimen (Treatment-Related)AEs84 Participants
PF-06647020 2.8 mg/kg (Q3W Regimen)Number of Participants With Treatment-Emergent AEs - Q3W Regimen (Treatment-Related)SAEs9 Participants
PF-06647020 3.7 mg/kg (Q3W Regimen)Number of Participants With Treatment-Emergent AEs - Q3W Regimen (Treatment-Related)SAEs0 Participants
PF-06647020 3.7 mg/kg (Q3W Regimen)Number of Participants With Treatment-Emergent AEs - Q3W Regimen (Treatment-Related)AEs5 Participants
Primary

Number of Participants With Urinalysis Laboratory Abnormalities (All Cycles) - Q2W Regimen

Participants who experienced urinalysis laboratory test abnormalities were summarized according to worst toxicity grade observed for each urinalysis laboratory test. Laboratory abnormalities were graded by NCI CTCAE version 4.03. This outcome measure calculated the number of participants with urinalysis laboratory abnormalities that were shifted from \<=Grade 2 at baseline to Grade 3 or above.

Time frame: Baseline and Day 1 of Cycle 1

Population: All participants enrolled in Q2W regimen who received at least 1 full or partial dose of study medication and had at least 1 observation of the given urinalysis laboratory test.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
PF-06647020 0.2 mg/kg(Q3W Regimen)Number of Participants With Urinalysis Laboratory Abnormalities (All Cycles) - Q2W Regimen0 Participants
PF-06647020 0.5 mg/kg (Q3W Regimen)Number of Participants With Urinalysis Laboratory Abnormalities (All Cycles) - Q2W Regimen0 Participants
PF-06647020 1.25 mg/kg (Q3W Regimen)Number of Participants With Urinalysis Laboratory Abnormalities (All Cycles) - Q2W Regimen0 Participants
Primary

Number of Participants With Urinalysis Laboratory Abnormalities (All Cycles) - Q3W Regimen

Participants who experienced urinalysis laboratory test abnormalities were summarized according to worst toxicity grade observed for each urinalysis laboratory test. Laboratory abnormalities were graded by NCI CTCAE version 4.03. This outcome measure calculated the number of participants with urinalysis laboratory abnormalities that were shifted from \<=Grade 2 at baseline to Grade 3 or above.

Time frame: From baseline to end of treatment (approximately 32 months).

Population: All participants enrolled in Q3W regimen who received at least 1 full or partial dose of study medication and had at least 1 observation of the given urinalysis laboratory test.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
PF-06647020 0.2 mg/kg(Q3W Regimen)Number of Participants With Urinalysis Laboratory Abnormalities (All Cycles) - Q3W Regimen0 Participants
PF-06647020 0.5 mg/kg (Q3W Regimen)Number of Participants With Urinalysis Laboratory Abnormalities (All Cycles) - Q3W Regimen0 Participants
PF-06647020 1.25 mg/kg (Q3W Regimen)Number of Participants With Urinalysis Laboratory Abnormalities (All Cycles) - Q3W Regimen0 Participants
PF-06647020 2.1 mg/kg (Q3W Regimen)Number of Participants With Urinalysis Laboratory Abnormalities (All Cycles) - Q3W Regimen0 Participants
PF-06647020 2.8 mg/kg (Q3W Regimen)Number of Participants With Urinalysis Laboratory Abnormalities (All Cycles) - Q3W Regimen0 Participants
PF-06647020 3.7 mg/kg (Q3W Regimen)Number of Participants With Urinalysis Laboratory Abnormalities (All Cycles) - Q3W Regimen0 Participants
Secondary

Area Under the Concentration-Time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) for PF-06647020 - Q3W Regimen

AUCinf is the area under the serum concentration-time profile from time 0 extrapolated to infinite time. AUCinf for PF-06647020 was calculated as AUClast + (Clast\*/kel), where AUClast was the area under the serum concentration-time profile from time 0 to the time of the last quantifiable concentration, Clast\* was the predicted serum concentration at the last quantifiable time point estimated from the log-linear regression analysis. kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.

Time frame: pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 4 (21 days cycle).

Population: All participants enrolled in Q3W regimen (except DDI sub-study) who received at least 1 dose of study treatment and had sufficient information to estimate at least 1 of the PK parameters of interest.

ArmMeasureGroupValue (GEOMETRIC_MEAN)Dispersion
PF-06647020 0.2 mg/kg(Q3W Regimen)Area Under the Concentration-Time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) for PF-06647020 - Q3W RegimenCycle 1, Single DoseNA µg•hr/mL
PF-06647020 0.2 mg/kg(Q3W Regimen)Area Under the Concentration-Time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) for PF-06647020 - Q3W RegimenCycle 4, Multiple DoseNA µg•hr/mL
PF-06647020 0.5 mg/kg (Q3W Regimen)Area Under the Concentration-Time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) for PF-06647020 - Q3W RegimenCycle 1, Single DoseNA µg•hr/mL
PF-06647020 1.25 mg/kg (Q3W Regimen)Area Under the Concentration-Time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) for PF-06647020 - Q3W RegimenCycle 1, Single DoseNA µg•hr/mL
PF-06647020 1.25 mg/kg (Q3W Regimen)Area Under the Concentration-Time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) for PF-06647020 - Q3W RegimenCycle 4, Multiple DoseNA µg•hr/mL
PF-06647020 2.1 mg/kg (Q3W Regimen)Area Under the Concentration-Time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) for PF-06647020 - Q3W RegimenCycle 4, Multiple Dose4312 µg•hr/mLGeometric Coefficient of Variation 102
PF-06647020 2.1 mg/kg (Q3W Regimen)Area Under the Concentration-Time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) for PF-06647020 - Q3W RegimenCycle 1, Single Dose4637 µg•hr/mLGeometric Coefficient of Variation 30
PF-06647020 2.8 mg/kg (Q3W Regimen)Area Under the Concentration-Time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) for PF-06647020 - Q3W RegimenCycle 1, Single Dose4829 µg•hr/mLGeometric Coefficient of Variation 63
PF-06647020 2.8 mg/kg (Q3W Regimen)Area Under the Concentration-Time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) for PF-06647020 - Q3W RegimenCycle 4, Multiple Dose6086 µg•hr/mLGeometric Coefficient of Variation 62
PF-06647020 3.7 mg/kg (Q3W Regimen)Area Under the Concentration-Time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) for PF-06647020 - Q3W RegimenCycle 4, Multiple DoseNA µg•hr/mL
PF-06647020 3.7 mg/kg (Q3W Regimen)Area Under the Concentration-Time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) for PF-06647020 - Q3W RegimenCycle 1, Single Dose7052 µg•hr/mLGeometric Coefficient of Variation 81
Secondary

Area Under the Concentration-Time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) for PF-06647020 - Q3W Regimen

AUClast is the area under the serum concentration-time profile from time 0 to the time of the last quantifiable concentration. AUClast for PF-06647020 was determined using linear/log trapezoidal method.

Time frame: pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 4 (21 days cycle).

Population: All participants enrolled in Q3W regimen (except DDI sub-study) who received at least 1 dose of study treatment and had sufficient information to estimate at least 1 of the PK parameters of interest.

ArmMeasureGroupValue (GEOMETRIC_MEAN)Dispersion
PF-06647020 0.2 mg/kg(Q3W Regimen)Area Under the Concentration-Time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) for PF-06647020 - Q3W RegimenCycle 1, Single DoseNA µg•hr/mL
PF-06647020 0.2 mg/kg(Q3W Regimen)Area Under the Concentration-Time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) for PF-06647020 - Q3W RegimenCycle 4, Multiple DoseNA µg•hr/mL
PF-06647020 0.5 mg/kg (Q3W Regimen)Area Under the Concentration-Time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) for PF-06647020 - Q3W RegimenCycle 1, Single DoseNA µg•hr/mL
PF-06647020 1.25 mg/kg (Q3W Regimen)Area Under the Concentration-Time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) for PF-06647020 - Q3W RegimenCycle 1, Single DoseNA µg•hr/mL
PF-06647020 1.25 mg/kg (Q3W Regimen)Area Under the Concentration-Time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) for PF-06647020 - Q3W RegimenCycle 4, Multiple DoseNA µg•hr/mL
PF-06647020 2.1 mg/kg (Q3W Regimen)Area Under the Concentration-Time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) for PF-06647020 - Q3W RegimenCycle 4, Multiple Dose4157 µg•hr/mLGeometric Coefficient of Variation 98
PF-06647020 2.1 mg/kg (Q3W Regimen)Area Under the Concentration-Time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) for PF-06647020 - Q3W RegimenCycle 1, Single Dose4570 µg•hr/mLGeometric Coefficient of Variation 30
PF-06647020 2.8 mg/kg (Q3W Regimen)Area Under the Concentration-Time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) for PF-06647020 - Q3W RegimenCycle 1, Single Dose4674 µg•hr/mLGeometric Coefficient of Variation 63
PF-06647020 2.8 mg/kg (Q3W Regimen)Area Under the Concentration-Time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) for PF-06647020 - Q3W RegimenCycle 4, Multiple Dose5428 µg•hr/mLGeometric Coefficient of Variation 83
PF-06647020 3.7 mg/kg (Q3W Regimen)Area Under the Concentration-Time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) for PF-06647020 - Q3W RegimenCycle 4, Multiple DoseNA µg•hr/mL
PF-06647020 3.7 mg/kg (Q3W Regimen)Area Under the Concentration-Time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) for PF-06647020 - Q3W RegimenCycle 1, Single Dose4450 µg•hr/mLGeometric Coefficient of Variation 198
Secondary

Area Under the Concentration-Time Profile From Time 0 to Time Tau (AUCtau) for PF-06647020 - Q3W Regimen

Tau refers to the dosing interval and it equals to 504 hours for the Q3W dosing. AUCtau is the area under the concentration-time profile from time 0 to time tau. AUCtau for PF-06647020 was determined using linear/log trapezoidal method.

Time frame: pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 4 (21 days cycle).

Population: All participants enrolled in Q3W regimen (except DDI sub-study) who received at least 1 dose of study treatment and had sufficient information to estimate at least 1 of the PK parameters of interest.

ArmMeasureGroupValue (GEOMETRIC_MEAN)Dispersion
PF-06647020 0.2 mg/kg(Q3W Regimen)Area Under the Concentration-Time Profile From Time 0 to Time Tau (AUCtau) for PF-06647020 - Q3W RegimenCycle 1, Single DoseNA microgram•hour/milliliter (µg•hr/mL)
PF-06647020 0.2 mg/kg(Q3W Regimen)Area Under the Concentration-Time Profile From Time 0 to Time Tau (AUCtau) for PF-06647020 - Q3W RegimenCycle 4, Multiple DoseNA microgram•hour/milliliter (µg•hr/mL)
PF-06647020 0.5 mg/kg (Q3W Regimen)Area Under the Concentration-Time Profile From Time 0 to Time Tau (AUCtau) for PF-06647020 - Q3W RegimenCycle 1, Single DoseNA microgram•hour/milliliter (µg•hr/mL)
PF-06647020 1.25 mg/kg (Q3W Regimen)Area Under the Concentration-Time Profile From Time 0 to Time Tau (AUCtau) for PF-06647020 - Q3W RegimenCycle 4, Multiple DoseNA microgram•hour/milliliter (µg•hr/mL)
PF-06647020 1.25 mg/kg (Q3W Regimen)Area Under the Concentration-Time Profile From Time 0 to Time Tau (AUCtau) for PF-06647020 - Q3W RegimenCycle 1, Single DoseNA microgram•hour/milliliter (µg•hr/mL)
PF-06647020 2.1 mg/kg (Q3W Regimen)Area Under the Concentration-Time Profile From Time 0 to Time Tau (AUCtau) for PF-06647020 - Q3W RegimenCycle 4, Multiple Dose4201 microgram•hour/milliliter (µg•hr/mL)Geometric Coefficient of Variation 95
PF-06647020 2.1 mg/kg (Q3W Regimen)Area Under the Concentration-Time Profile From Time 0 to Time Tau (AUCtau) for PF-06647020 - Q3W RegimenCycle 1, Single Dose4570 microgram•hour/milliliter (µg•hr/mL)Geometric Coefficient of Variation 30
PF-06647020 2.8 mg/kg (Q3W Regimen)Area Under the Concentration-Time Profile From Time 0 to Time Tau (AUCtau) for PF-06647020 - Q3W RegimenCycle 1, Single Dose4782 microgram•hour/milliliter (µg•hr/mL)Geometric Coefficient of Variation 61
PF-06647020 2.8 mg/kg (Q3W Regimen)Area Under the Concentration-Time Profile From Time 0 to Time Tau (AUCtau) for PF-06647020 - Q3W RegimenCycle 4, Multiple Dose5834 microgram•hour/milliliter (µg•hr/mL)Geometric Coefficient of Variation 60
PF-06647020 3.7 mg/kg (Q3W Regimen)Area Under the Concentration-Time Profile From Time 0 to Time Tau (AUCtau) for PF-06647020 - Q3W RegimenCycle 1, Single Dose6929 microgram•hour/milliliter (µg•hr/mL)Geometric Coefficient of Variation 80
PF-06647020 3.7 mg/kg (Q3W Regimen)Area Under the Concentration-Time Profile From Time 0 to Time Tau (AUCtau) for PF-06647020 - Q3W RegimenCycle 4, Multiple DoseNA microgram•hour/milliliter (µg•hr/mL)
Secondary

AUCinf(dn) for hu6M024 mAb [DDI Sub-Study]

AUCinf is the area under the serum concentration-time profile from time 0 extrapolated to infinite time. AUCinf(dn) was defined as dose normalized AUCinf and calculated as AUCinf/dose.

Time frame: pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 2 (21 days cycle).

Population: Participants who participated in the DDI sub-study, and had at least one of the study required PK samples.

ArmMeasureValue (GEOMETRIC_MEAN)Dispersion
PF-06647020 0.2 mg/kg(Q3W Regimen)AUCinf(dn) for hu6M024 mAb [DDI Sub-Study]31.94 µg•hr/mL/mgGeometric Coefficient of Variation 45
PF-06647020 0.5 mg/kg (Q3W Regimen)AUCinf(dn) for hu6M024 mAb [DDI Sub-Study]25.92 µg•hr/mL/mgGeometric Coefficient of Variation 46
Comparison: Test: PF-06647020 1.4 mg/kg + Fluconazole(Q3W-DDI) group; Reference: PF-06647020 2.8 mg/kg (Q3W-DDI) group.p-value: 0.295190% CI: [57.99, 113.54]ANOVA
Secondary

AUCinf(dn) for PF-06380101 [DDI Sub-Study]

AUCinf is the area under the serum concentration-time profile from time 0 extrapolated to infinite time. AUCinf(dn) was defined as dose normalized AUCinf and calculated as AUCinf/dose.

Time frame: pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 2 (21 days cycle).

Population: Participants who participated in the DDI sub-study, and had at least one of the study required PK samples.

ArmMeasureValue (GEOMETRIC_MEAN)Dispersion
PF-06647020 0.2 mg/kg(Q3W Regimen)AUCinf(dn) for PF-06380101 [DDI Sub-Study]5.787 ng•hr/mL/mgGeometric Coefficient of Variation 116
PF-06647020 0.5 mg/kg (Q3W Regimen)AUCinf(dn) for PF-06380101 [DDI Sub-Study]5.275 ng•hr/mL/mgGeometric Coefficient of Variation 123
Comparison: Test: PF-06647020 1.4 mg/kg + Fluconazole(Q3W-DDI) group; Reference: PF-06647020 2.8 mg/kg (Q3W-DDI) group.p-value: 0.82490% CI: [44.79, 185.5]ANOVA
Secondary

AUCinf for hu6M024 mAb - Q2W Regimen

AUCinf is the area under the serum concentration-time profile from time 0 extrapolated to infinite time. AUCinf was calculated as AUClast + (Clast\*/kel), where AUClast was the area under the serum concentration-time profile from time 0 to the time of the last quantifiable concentration, Clast\* was the predicted serum concentration at the last quantifiable time point estimated from the log-linear regression analysis. kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.

Time frame: pre-dose, end of infusion, 4, 24, 72, 168 hours post-dose, Day 15 (pre-dose, end of infusion) for Cycle 1 and Cycle 3 (28 days cycle).

Population: All participants enrolled in Q2W regimen who received at least 1 dose of study treatment and had sufficient information to estimate at least 1 of the PK parameters of interest.

ArmMeasureGroupValue (GEOMETRIC_MEAN)Dispersion
PF-06647020 0.2 mg/kg(Q3W Regimen)AUCinf for hu6M024 mAb - Q2W RegimenCycle 1, Single DoseNA µg•hr/mL
PF-06647020 0.2 mg/kg(Q3W Regimen)AUCinf for hu6M024 mAb - Q2W RegimenCycle 3, Multiple DoseNA µg•hr/mL
PF-06647020 0.5 mg/kg (Q3W Regimen)AUCinf for hu6M024 mAb - Q2W RegimenCycle 1, Single Dose7742 µg•hr/mLGeometric Coefficient of Variation 47
PF-06647020 0.5 mg/kg (Q3W Regimen)AUCinf for hu6M024 mAb - Q2W RegimenCycle 3, Multiple Dose10950 µg•hr/mLGeometric Coefficient of Variation 22
PF-06647020 1.25 mg/kg (Q3W Regimen)AUCinf for hu6M024 mAb - Q2W RegimenCycle 1, Single Dose7411 µg•hr/mLGeometric Coefficient of Variation 48
PF-06647020 1.25 mg/kg (Q3W Regimen)AUCinf for hu6M024 mAb - Q2W RegimenCycle 3, Multiple Dose8275 µg•hr/mLGeometric Coefficient of Variation 44
Secondary

AUCinf for hu6M024 mAb - Q3W Regimen

AUCinf is the area under the serum concentration-time profile from time 0 extrapolated to infinite time. AUCinf for hu6M024 mAb was calculated as AUClast + (Clast\*/kel), where AUClast was the area under the serum concentration-time profile from time 0 to the time of the last quantifiable concentration, Clast\* was the predicted serum concentration at the last quantifiable time point estimated from the log-linear regression analysis. kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.

Time frame: pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 4 (21 days cycle).

Population: All participants enrolled in Q3W regimen (except DDI sub-study) who received at least 1 dose of study treatment and had sufficient information to estimate at least 1 of the PK parameters of interest.

ArmMeasureGroupValue (GEOMETRIC_MEAN)Dispersion
PF-06647020 0.2 mg/kg(Q3W Regimen)AUCinf for hu6M024 mAb - Q3W RegimenCycle 1, Single DoseNA µg•hr/mL
PF-06647020 0.5 mg/kg (Q3W Regimen)AUCinf for hu6M024 mAb - Q3W RegimenCycle 1, Single DoseNA µg•hr/mL
PF-06647020 1.25 mg/kg (Q3W Regimen)AUCinf for hu6M024 mAb - Q3W RegimenCycle 4, Multiple DoseNA µg•hr/mL
PF-06647020 1.25 mg/kg (Q3W Regimen)AUCinf for hu6M024 mAb - Q3W RegimenCycle 1, Single DoseNA µg•hr/mL
PF-06647020 2.1 mg/kg (Q3W Regimen)AUCinf for hu6M024 mAb - Q3W RegimenCycle 4, Multiple Dose6517 µg•hr/mLGeometric Coefficient of Variation 156
PF-06647020 2.1 mg/kg (Q3W Regimen)AUCinf for hu6M024 mAb - Q3W RegimenCycle 1, Single Dose7189 µg•hr/mLGeometric Coefficient of Variation 32
PF-06647020 2.8 mg/kg (Q3W Regimen)AUCinf for hu6M024 mAb - Q3W RegimenCycle 1, Single Dose5608 µg•hr/mLGeometric Coefficient of Variation 65
PF-06647020 2.8 mg/kg (Q3W Regimen)AUCinf for hu6M024 mAb - Q3W RegimenCycle 4, Multiple Dose6191 µg•hr/mLGeometric Coefficient of Variation 94
PF-06647020 3.7 mg/kg (Q3W Regimen)AUCinf for hu6M024 mAb - Q3W RegimenCycle 4, Multiple DoseNA µg•hr/mL
PF-06647020 3.7 mg/kg (Q3W Regimen)AUCinf for hu6M024 mAb - Q3W RegimenCycle 1, Single Dose8760 µg•hr/mLGeometric Coefficient of Variation 80
Secondary

AUCinf for PF-06380101- Q2W Regimen

AUCinf is the area under the serum concentration-time profile from time 0 extrapolated to infinite time. AUCinf was calculated as AUClast + (Clast\*/kel), where AUClast was the area under the serum concentration-time profile from time 0 to the time of the last quantifiable concentration, Clast\* was the predicted serum concentration at the last quantifiable time point estimated from the log-linear regression analysis. kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.

Time frame: pre-dose, end of infusion, 4, 24, 72, 168 hours post-dose, Day 15 (pre-dose, end of infusion) for Cycle 1 and Cycle 3 (28 days cycle).

Population: All participants enrolled in Q2W regimen who received at least 1 dose of study treatment and had sufficient information to estimate at least 1 of the PK parameters of interest.

ArmMeasureGroupValue (GEOMETRIC_MEAN)Dispersion
PF-06647020 0.2 mg/kg(Q3W Regimen)AUCinf for PF-06380101- Q2W RegimenCycle 1, Single Dose584.4 ng•hr/mLGeometric Coefficient of Variation 11
PF-06647020 0.2 mg/kg(Q3W Regimen)AUCinf for PF-06380101- Q2W RegimenCycle 3, Multiple DoseNA ng•hr/mL
PF-06647020 0.5 mg/kg (Q3W Regimen)AUCinf for PF-06380101- Q2W RegimenCycle 1, Single Dose888.5 ng•hr/mLGeometric Coefficient of Variation 54
PF-06647020 0.5 mg/kg (Q3W Regimen)AUCinf for PF-06380101- Q2W RegimenCycle 3, Multiple Dose738.8 ng•hr/mLGeometric Coefficient of Variation 69
PF-06647020 1.25 mg/kg (Q3W Regimen)AUCinf for PF-06380101- Q2W RegimenCycle 1, Single Dose763.2 ng•hr/mLGeometric Coefficient of Variation 62
PF-06647020 1.25 mg/kg (Q3W Regimen)AUCinf for PF-06380101- Q2W RegimenCycle 3, Multiple Dose617.9 ng•hr/mLGeometric Coefficient of Variation 32
Secondary

AUCinf for PF-06380101 - Q3W Regimen

AUCinf is the area under the serum concentration-time profile from time 0 extrapolated to infinite time. AUCinf for PF-06380101 was calculated as AUClast + (Clast\*/kel), where AUClast was the area under the serum concentration-time profile from time 0 to the time of the last quantifiable concentration, Clast\* was the predicted serum concentration at the last quantifiable time point estimated from the log-linear regression analysis. kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.

Time frame: pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 4 (21 days cycle).

Population: All participants enrolled in Q3W regimen (except DDI sub-study) who received at least 1 dose of study treatment and had sufficient information to estimate at least 1 of the PK parameters of interest.

ArmMeasureGroupValue (GEOMETRIC_MEAN)Dispersion
PF-06647020 0.2 mg/kg(Q3W Regimen)AUCinf for PF-06380101 - Q3W RegimenCycle 4, Multiple DoseNA ng•hr/mL
PF-06647020 0.2 mg/kg(Q3W Regimen)AUCinf for PF-06380101 - Q3W RegimenCycle 1, Single DoseNA ng•hr/mL
PF-06647020 0.5 mg/kg (Q3W Regimen)AUCinf for PF-06380101 - Q3W RegimenCycle 1, Single DoseNA ng•hr/mL
PF-06647020 1.25 mg/kg (Q3W Regimen)AUCinf for PF-06380101 - Q3W RegimenCycle 1, Single DoseNA ng•hr/mL
PF-06647020 1.25 mg/kg (Q3W Regimen)AUCinf for PF-06380101 - Q3W RegimenCycle 4, Multiple DoseNA ng•hr/mL
PF-06647020 2.1 mg/kg (Q3W Regimen)AUCinf for PF-06380101 - Q3W RegimenCycle 1, Single Dose851.4 ng•hr/mLGeometric Coefficient of Variation 45
PF-06647020 2.1 mg/kg (Q3W Regimen)AUCinf for PF-06380101 - Q3W RegimenCycle 4, Multiple Dose422.9 ng•hr/mLGeometric Coefficient of Variation 105
PF-06647020 2.8 mg/kg (Q3W Regimen)AUCinf for PF-06380101 - Q3W RegimenCycle 1, Single Dose812.2 ng•hr/mLGeometric Coefficient of Variation 68
PF-06647020 2.8 mg/kg (Q3W Regimen)AUCinf for PF-06380101 - Q3W RegimenCycle 4, Multiple Dose645.2 ng•hr/mLGeometric Coefficient of Variation 48
PF-06647020 3.7 mg/kg (Q3W Regimen)AUCinf for PF-06380101 - Q3W RegimenCycle 4, Multiple DoseNA ng•hr/mL
PF-06647020 3.7 mg/kg (Q3W Regimen)AUCinf for PF-06380101 - Q3W RegimenCycle 1, Single Dose1020 ng•hr/mLGeometric Coefficient of Variation 95
Secondary

AUCinf for PF-06647020 - Q2W Regimen

AUCinf is the area under the serum concentration-time profile from time 0 extrapolated to infinite time. AUCinf was calculated as AUClast + (Clast\*/kel), where AUClast was the area under the serum concentration-time profile from time 0 to the time of the last quantifiable concentration, Clast\* was the predicted serum concentration at the last quantifiable time point estimated from the log-linear regression analysis. kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.

Time frame: pre-dose, end of infusion, 4, 24, 72, 168 hours post-dose, Day 15 (pre-dose, end of infusion) for Cycle 1 and Cycle 3 (28 days cycle).

Population: All participants enrolled in Q2W regimen who received at least 1 dose of study treatment and had sufficient information to estimate at least 1 of the PK parameters of interest.

ArmMeasureGroupValue (GEOMETRIC_MEAN)Dispersion
PF-06647020 0.2 mg/kg(Q3W Regimen)AUCinf for PF-06647020 - Q2W RegimenCycle 1, Single DoseNA µg•hr/mL
PF-06647020 0.2 mg/kg(Q3W Regimen)AUCinf for PF-06647020 - Q2W RegimenCycle 3, Multiple DoseNA µg•hr/mL
PF-06647020 0.5 mg/kg (Q3W Regimen)AUCinf for PF-06647020 - Q2W RegimenCycle 1, Single Dose6798 µg•hr/mLGeometric Coefficient of Variation 41
PF-06647020 0.5 mg/kg (Q3W Regimen)AUCinf for PF-06647020 - Q2W RegimenCycle 3, Multiple Dose10570 µg•hr/mLGeometric Coefficient of Variation 22
PF-06647020 1.25 mg/kg (Q3W Regimen)AUCinf for PF-06647020 - Q2W RegimenCycle 1, Single Dose6535 µg•hr/mLGeometric Coefficient of Variation 46
PF-06647020 1.25 mg/kg (Q3W Regimen)AUCinf for PF-06647020 - Q2W RegimenCycle 3, Multiple Dose7445 µg•hr/mLGeometric Coefficient of Variation 44
Secondary

AUClast(dn) for hu6M024 mAb [DDI Sub-Study]

AUClast is the area under the serum concentration-time profile from time 0 to the time of the last quantifiable concentration. AUClast(dn) was defined as dose normalized AUClast and calculated as AUClast/dose.

Time frame: pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 2 (21 days cycle).

Population: Participants who participated in the DDI sub-study, and had at least one of the study required PK samples.

ArmMeasureValue (GEOMETRIC_MEAN)Dispersion
PF-06647020 0.2 mg/kg(Q3W Regimen)AUClast(dn) for hu6M024 mAb [DDI Sub-Study]31.30 µg•hr/mL/mgGeometric Coefficient of Variation 44
PF-06647020 0.5 mg/kg (Q3W Regimen)AUClast(dn) for hu6M024 mAb [DDI Sub-Study]26.30 µg•hr/mL/mgGeometric Coefficient of Variation 48
Comparison: Test: PF-06647020 1.4 mg/kg + Fluconazole(Q3W-DDI) group; Reference: PF-06647020 2.8 mg/kg (Q3W-DDI) group.p-value: 0.376990% CI: [60.24, 117.19]ANOVA
Secondary

AUClast(dn) for PF-06380101 [DDI Sub-Study]

AUClast is the area under the serum concentration-time profile from time 0 to the time of the last quantifiable concentration. AUClast(dn) was defined as dose normalized AUClast and calculated as AUClast/dose.

Time frame: pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 2 (21 days cycle).

Population: Participants who participated in the DDI sub-study, and had at least one of the study required PK samples.

ArmMeasureValue (GEOMETRIC_MEAN)Dispersion
PF-06647020 0.2 mg/kg(Q3W Regimen)AUClast(dn) for PF-06380101 [DDI Sub-Study]5.681 ng•hr/mL/mgGeometric Coefficient of Variation 112
PF-06647020 0.5 mg/kg (Q3W Regimen)AUClast(dn) for PF-06380101 [DDI Sub-Study]5.089 ng•hr/mL/mgGeometric Coefficient of Variation 128
Comparison: Test: PF-06647020 1.4 mg/kg + Fluconazole(Q3W-DDI) group; Reference: PF-06647020 2.8 mg/kg (Q3W-DDI) group.p-value: 0.792290% CI: [43.94, 182.62]ANOVA
Secondary

AUClast for hu6M024 mAb - Q2W Regimen

AUClast is the area under the serum concentration-time profile from time 0 to the time of the last quantifiable concentration. AUClast for hu6M024 mAb was determined using linear/log trapezoidal method.

Time frame: pre-dose, end of infusion, 4, 24, 72, 168 hours post-dose, Day 15 (pre-dose, end of infusion) for Cycle 1 and Cycle 3 (28 days cycle).

Population: All participants enrolled in Q2W regimen who received at least 1 dose of study treatment and had sufficient information to estimate at least 1 of the PK parameters of interest.

ArmMeasureGroupValue (GEOMETRIC_MEAN)Dispersion
PF-06647020 0.2 mg/kg(Q3W Regimen)AUClast for hu6M024 mAb - Q2W RegimenCycle 1, Single Dose4103 µg•hr/mLGeometric Coefficient of Variation 52
PF-06647020 0.2 mg/kg(Q3W Regimen)AUClast for hu6M024 mAb - Q2W RegimenCycle 3, Multiple DoseNA µg•hr/mL
PF-06647020 0.5 mg/kg (Q3W Regimen)AUClast for hu6M024 mAb - Q2W RegimenCycle 1, Single Dose7368 µg•hr/mLGeometric Coefficient of Variation 46
PF-06647020 0.5 mg/kg (Q3W Regimen)AUClast for hu6M024 mAb - Q2W RegimenCycle 3, Multiple Dose10460 µg•hr/mLGeometric Coefficient of Variation 24
PF-06647020 1.25 mg/kg (Q3W Regimen)AUClast for hu6M024 mAb - Q2W RegimenCycle 1, Single Dose6949 µg•hr/mLGeometric Coefficient of Variation 45
PF-06647020 1.25 mg/kg (Q3W Regimen)AUClast for hu6M024 mAb - Q2W RegimenCycle 3, Multiple Dose8555 µg•hr/mLGeometric Coefficient of Variation 41
Secondary

AUClast for hu6M024 mAb - Q3W Regimen

AUClast is the area under the serum concentration-time profile from time 0 to the time of the last quantifiable concentration. AUClast for hu6M024 mAb was determined using linear/log trapezoidal method.

Time frame: pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 4 (21 days cycle).

Population: All participants enrolled in Q3W regimen (except DDI sub-study) who received at least 1 dose of study treatment and had sufficient information to estimate at least 1 of the PK parameters of interest.

ArmMeasureGroupValue (GEOMETRIC_MEAN)Dispersion
PF-06647020 0.2 mg/kg(Q3W Regimen)AUClast for hu6M024 mAb - Q3W RegimenCycle 4, Multiple DoseNA µg•hr/mL
PF-06647020 0.2 mg/kg(Q3W Regimen)AUClast for hu6M024 mAb - Q3W RegimenCycle 1, Single DoseNA µg•hr/mL
PF-06647020 0.5 mg/kg (Q3W Regimen)AUClast for hu6M024 mAb - Q3W RegimenCycle 1, Single DoseNA µg•hr/mL
PF-06647020 1.25 mg/kg (Q3W Regimen)AUClast for hu6M024 mAb - Q3W RegimenCycle 1, Single DoseNA µg•hr/mL
PF-06647020 1.25 mg/kg (Q3W Regimen)AUClast for hu6M024 mAb - Q3W RegimenCycle 4, Multiple DoseNA µg•hr/mL
PF-06647020 2.1 mg/kg (Q3W Regimen)AUClast for hu6M024 mAb - Q3W RegimenCycle 1, Single Dose6969 µg•hr/mLGeometric Coefficient of Variation 32
PF-06647020 2.1 mg/kg (Q3W Regimen)AUClast for hu6M024 mAb - Q3W RegimenCycle 4, Multiple Dose6127 µg•hr/mLGeometric Coefficient of Variation 147
PF-06647020 2.8 mg/kg (Q3W Regimen)AUClast for hu6M024 mAb - Q3W RegimenCycle 1, Single Dose5449 µg•hr/mLGeometric Coefficient of Variation 64
PF-06647020 2.8 mg/kg (Q3W Regimen)AUClast for hu6M024 mAb - Q3W RegimenCycle 4, Multiple Dose5885 µg•hr/mLGeometric Coefficient of Variation 97
PF-06647020 3.7 mg/kg (Q3W Regimen)AUClast for hu6M024 mAb - Q3W RegimenCycle 4, Multiple DoseNA µg•hr/mL
PF-06647020 3.7 mg/kg (Q3W Regimen)AUClast for hu6M024 mAb - Q3W RegimenCycle 1, Single Dose5247 µg•hr/mLGeometric Coefficient of Variation 221
Secondary

AUClast for PF-06380101- Q2W Regimen

AUClast is the area under the serum concentration-time profile from time 0 to the time of the last quantifiable concentration. AUClast for PF-06380101 was determined using linear/log trapezoidal method.

Time frame: pre-dose, end of infusion, 4, 24, 72, 168 hours post-dose, Day 15 (pre-dose, end of infusion) for Cycle 1 and Cycle 3 (28 days cycle).

Population: All participants enrolled in Q2W regimen who received at least 1 dose of study treatment and had sufficient information to estimate at least 1 of the PK parameters of interest.

ArmMeasureGroupValue (GEOMETRIC_MEAN)Dispersion
PF-06647020 0.2 mg/kg(Q3W Regimen)AUClast for PF-06380101- Q2W RegimenCycle 1, Single Dose569.9 ng•hr/mLGeometric Coefficient of Variation 12
PF-06647020 0.2 mg/kg(Q3W Regimen)AUClast for PF-06380101- Q2W RegimenCycle 3, Multiple DoseNA ng•hr/mL
PF-06647020 0.5 mg/kg (Q3W Regimen)AUClast for PF-06380101- Q2W RegimenCycle 1, Single Dose866.0 ng•hr/mLGeometric Coefficient of Variation 53
PF-06647020 0.5 mg/kg (Q3W Regimen)AUClast for PF-06380101- Q2W RegimenCycle 3, Multiple Dose728.9 ng•hr/mLGeometric Coefficient of Variation 60
PF-06647020 1.25 mg/kg (Q3W Regimen)AUClast for PF-06380101- Q2W RegimenCycle 1, Single Dose743.5 ng•hr/mLGeometric Coefficient of Variation 63
PF-06647020 1.25 mg/kg (Q3W Regimen)AUClast for PF-06380101- Q2W RegimenCycle 3, Multiple Dose593.3 ng•hr/mLGeometric Coefficient of Variation 33
Secondary

AUClast for PF-06380101 - Q3W Regimen

AUClast is the area under the serum concentration-time profile from time 0 to the time of the last quantifiable concentration. AUClast for PF-06380101 was determined using linear/log trapezoidal method.

Time frame: pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 4 (21 days cycle).

Population: All participants enrolled in Q3W regimen (except DDI sub-study) who received at least 1 dose of study treatment and had sufficient information to estimate at least 1 of the PK parameters of interest.

ArmMeasureGroupValue (GEOMETRIC_MEAN)Dispersion
PF-06647020 0.2 mg/kg(Q3W Regimen)AUClast for PF-06380101 - Q3W RegimenCycle 4, Multiple DoseNA ng•hr/mL
PF-06647020 0.2 mg/kg(Q3W Regimen)AUClast for PF-06380101 - Q3W RegimenCycle 1, Single DoseNA ng•hr/mL
PF-06647020 0.5 mg/kg (Q3W Regimen)AUClast for PF-06380101 - Q3W RegimenCycle 1, Single DoseNA ng•hr/mL
PF-06647020 1.25 mg/kg (Q3W Regimen)AUClast for PF-06380101 - Q3W RegimenCycle 1, Single DoseNA ng•hr/mL
PF-06647020 1.25 mg/kg (Q3W Regimen)AUClast for PF-06380101 - Q3W RegimenCycle 4, Multiple DoseNA ng•hr/mL
PF-06647020 2.1 mg/kg (Q3W Regimen)AUClast for PF-06380101 - Q3W RegimenCycle 1, Single Dose844.6 ng•hr/mLGeometric Coefficient of Variation 46
PF-06647020 2.1 mg/kg (Q3W Regimen)AUClast for PF-06380101 - Q3W RegimenCycle 4, Multiple Dose418.5 ng•hr/mLGeometric Coefficient of Variation 106
PF-06647020 2.8 mg/kg (Q3W Regimen)AUClast for PF-06380101 - Q3W RegimenCycle 1, Single Dose799.3 ng•hr/mLGeometric Coefficient of Variation 68
PF-06647020 2.8 mg/kg (Q3W Regimen)AUClast for PF-06380101 - Q3W RegimenCycle 4, Multiple Dose643.6 ng•hr/mLGeometric Coefficient of Variation 48
PF-06647020 3.7 mg/kg (Q3W Regimen)AUClast for PF-06380101 - Q3W RegimenCycle 4, Multiple DoseNA ng•hr/mL
PF-06647020 3.7 mg/kg (Q3W Regimen)AUClast for PF-06380101 - Q3W RegimenCycle 1, Single Dose490.5 ng•hr/mLGeometric Coefficient of Variation 615
Secondary

AUClast for PF-06647020 - Q2W Regimen

AUClast is the area under the serum concentration-time profile from time 0 to the time of the last quantifiable concentration. AUClast for PF-06647020 was determined using linear/log trapezoidal method.

Time frame: pre-dose, end of infusion, 4, 24, 72, 168 hours post-dose, Day 15 (pre-dose, end of infusion) for Cycle 1 and Cycle 3 (28 days cycle).

Population: All participants enrolled in Q2W regimen who received at least 1 dose of study treatment and had sufficient information to estimate at least 1 of the PK parameters of interest.

ArmMeasureGroupValue (GEOMETRIC_MEAN)Dispersion
PF-06647020 0.2 mg/kg(Q3W Regimen)AUClast for PF-06647020 - Q2W RegimenCycle 1, Single Dose3641 µg•hr/mLGeometric Coefficient of Variation 62
PF-06647020 0.2 mg/kg(Q3W Regimen)AUClast for PF-06647020 - Q2W RegimenCycle 3, Multiple DoseNA µg•hr/mL
PF-06647020 0.5 mg/kg (Q3W Regimen)AUClast for PF-06647020 - Q2W RegimenCycle 1, Single Dose6490 µg•hr/mLGeometric Coefficient of Variation 39
PF-06647020 0.5 mg/kg (Q3W Regimen)AUClast for PF-06647020 - Q2W RegimenCycle 3, Multiple Dose9864 µg•hr/mLGeometric Coefficient of Variation 20
PF-06647020 1.25 mg/kg (Q3W Regimen)AUClast for PF-06647020 - Q2W RegimenCycle 1, Single Dose6342 µg•hr/mLGeometric Coefficient of Variation 46
PF-06647020 1.25 mg/kg (Q3W Regimen)AUClast for PF-06647020 - Q2W RegimenCycle 3, Multiple Dose7000 µg•hr/mLGeometric Coefficient of Variation 43
Secondary

AUCtau(dn) for hu6M024 mAb [DDI Sub-Study]

AUCtau is the area under the concentration-time profile from time 0 to time tau. AUCtau(dn) was defined as dose normalized AUCtau and calculated as AUCtau/dose.

Time frame: pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 2 (21 days cycle).

Population: Participants who participated in the DDI sub-study, and had at least one of the study required PK samples.

ArmMeasureValue (GEOMETRIC_MEAN)Dispersion
PF-06647020 0.2 mg/kg(Q3W Regimen)AUCtau(dn) for hu6M024 mAb [DDI Sub-Study]31.29 µg•hr/mL/mgGeometric Coefficient of Variation 44
PF-06647020 0.5 mg/kg (Q3W Regimen)AUCtau(dn) for hu6M024 mAb [DDI Sub-Study]26.96 µg•hr/mL/mgGeometric Coefficient of Variation 46
Comparison: Test: PF-06647020 1.4 mg/kg + Fluconazole(Q3W-DDI) group; Reference: PF-06647020 2.8 mg/kg (Q3W-DDI) group.p-value: 0.438590% CI: [62.2, 119.32]ANOVA
Secondary

AUCtau(dn) for PF-06380101 [DDI Sub-Study]

AUCtau is the area under the concentration-time profile from time 0 to time tau. AUCtau(dn) was defined as dose normalized AUCtau and calculated as AUCtau/dose.

Time frame: pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 2 (21 days cycle).

Population: Participants who participated in the DDI sub-study, and had at least one of the study required PK samples.

ArmMeasureValue (GEOMETRIC_MEAN)Dispersion
PF-06647020 0.2 mg/kg(Q3W Regimen)AUCtau(dn) for PF-06380101 [DDI Sub-Study]5.746 ng•hr/mL/mgGeometric Coefficient of Variation 115
PF-06647020 0.5 mg/kg (Q3W Regimen)AUCtau(dn) for PF-06380101 [DDI Sub-Study]5.239 ng•hr/mL/mgGeometric Coefficient of Variation 123
Comparison: Test: PF-06647020 1.4 mg/kg + Fluconazole(Q3W-DDI) group; Reference: PF-06647020 2.8 mg/kg (Q3W-DDI) group.p-value: 0.82490% CI: [44.87, 185.25]ANOVA
Secondary

AUCtau for hu6M024 mAb- Q2W Regimen

Tau refers to the dosing interval and it equals to 336 hours for the Q2W dosing. AUCtau is the area under the concentration-time profile from time 0 to time tau. AUCtau for hu6M024 mA was determined using linear/log trapezoidal method.

Time frame: pre-dose, end of infusion, 4, 24, 72, 168 hours post-dose, Day 15 (pre-dose, end of infusion) for Cycle 1 and Cycle 3 (28 days cycle).

Population: All participants enrolled in Q2W regimen who received at least 1 dose of study treatment and had sufficient information to estimate at least 1 of the PK parameters of interest.

ArmMeasureGroupValue (GEOMETRIC_MEAN)Dispersion
PF-06647020 0.2 mg/kg(Q3W Regimen)AUCtau for hu6M024 mAb- Q2W RegimenCycle 3, Multiple DoseNA µg•hr/mL
PF-06647020 0.2 mg/kg(Q3W Regimen)AUCtau for hu6M024 mAb- Q2W RegimenCycle 1, Single Dose4089 µg•hr/mLGeometric Coefficient of Variation 52
PF-06647020 0.5 mg/kg (Q3W Regimen)AUCtau for hu6M024 mAb- Q2W RegimenCycle 1, Single Dose7325 µg•hr/mLGeometric Coefficient of Variation 47
PF-06647020 0.5 mg/kg (Q3W Regimen)AUCtau for hu6M024 mAb- Q2W RegimenCycle 3, Multiple Dose10440 µg•hr/mLGeometric Coefficient of Variation 25
PF-06647020 1.25 mg/kg (Q3W Regimen)AUCtau for hu6M024 mAb- Q2W RegimenCycle 1, Single Dose6911 µg•hr/mLGeometric Coefficient of Variation 44
PF-06647020 1.25 mg/kg (Q3W Regimen)AUCtau for hu6M024 mAb- Q2W RegimenCycle 3, Multiple Dose8432 µg•hr/mLGeometric Coefficient of Variation 42
Secondary

AUCtau for hu6M024 mAb - Q3W Regimen

Tau refers to the dosing interval and it equals to 504 hours for the Q3W dosing. AUCtau is the area under the concentration-time profile from time 0 to time tau. AUCtau for hu6M024 mAb was determined using linear/log trapezoidal method.

Time frame: pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 4 (21 days cycle).

Population: All participants enrolled in Q3W regimen (except DDI sub-study) who received at least 1 dose of study treatment and had sufficient information to estimate at least 1 of the PK parameters of interest.

ArmMeasureGroupValue (GEOMETRIC_MEAN)Dispersion
PF-06647020 0.2 mg/kg(Q3W Regimen)AUCtau for hu6M024 mAb - Q3W RegimenCycle 4, Multiple DoseNA µg•hr/mL
PF-06647020 0.2 mg/kg(Q3W Regimen)AUCtau for hu6M024 mAb - Q3W RegimenCycle 1, Single DoseNA µg•hr/mL
PF-06647020 0.5 mg/kg (Q3W Regimen)AUCtau for hu6M024 mAb - Q3W RegimenCycle 1, Single DoseNA µg•hr/mL
PF-06647020 1.25 mg/kg (Q3W Regimen)AUCtau for hu6M024 mAb - Q3W RegimenCycle 1, Single DoseNA µg•hr/mL
PF-06647020 1.25 mg/kg (Q3W Regimen)AUCtau for hu6M024 mAb - Q3W RegimenCycle 4, Multiple DoseNA µg•hr/mL
PF-06647020 2.1 mg/kg (Q3W Regimen)AUCtau for hu6M024 mAb - Q3W RegimenCycle 1, Single Dose6968 µg•hr/mLGeometric Coefficient of Variation 32
PF-06647020 2.1 mg/kg (Q3W Regimen)AUCtau for hu6M024 mAb - Q3W RegimenCycle 4, Multiple Dose6122 µg•hr/mLGeometric Coefficient of Variation 145
PF-06647020 2.8 mg/kg (Q3W Regimen)AUCtau for hu6M024 mAb - Q3W RegimenCycle 1, Single Dose5562 µg•hr/mLGeometric Coefficient of Variation 62
PF-06647020 2.8 mg/kg (Q3W Regimen)AUCtau for hu6M024 mAb - Q3W RegimenCycle 4, Multiple Dose6210 µg•hr/mLGeometric Coefficient of Variation 80
PF-06647020 3.7 mg/kg (Q3W Regimen)AUCtau for hu6M024 mAb - Q3W RegimenCycle 4, Multiple DoseNA µg•hr/mL
PF-06647020 3.7 mg/kg (Q3W Regimen)AUCtau for hu6M024 mAb - Q3W RegimenCycle 1, Single Dose8451 µg•hr/mLGeometric Coefficient of Variation 78
Secondary

AUCtau for PF-06380101 - Q2W Regimen

Tau refers to the dosing interval and it equals to 336 hours for the Q2W dosing. AUCtau is the area under the concentration-time profile from time 0 to time tau. AUCtau for PF-06380101 was determined using linear/log trapezoidal method.

Time frame: pre-dose, end of infusion, 4, 24, 72, 168 hours post-dose, Day 15 (pre-dose, end of infusion) for Cycle 1 and Cycle 3 (28 days cycle).

Population: All participants enrolled in Q2W regimen who received at least 1 dose of study treatment and had sufficient information to estimate at least 1 of the PK parameters of interest.

ArmMeasureGroupValue (GEOMETRIC_MEAN)Dispersion
PF-06647020 0.2 mg/kg(Q3W Regimen)AUCtau for PF-06380101 - Q2W RegimenCycle 1, Single Dose568.9 ng•hr/mLGeometric Coefficient of Variation 12
PF-06647020 0.2 mg/kg(Q3W Regimen)AUCtau for PF-06380101 - Q2W RegimenCycle 3, Multiple DoseNA ng•hr/mL
PF-06647020 0.5 mg/kg (Q3W Regimen)AUCtau for PF-06380101 - Q2W RegimenCycle 3, Multiple Dose731.5 ng•hr/mLGeometric Coefficient of Variation 61
PF-06647020 0.5 mg/kg (Q3W Regimen)AUCtau for PF-06380101 - Q2W RegimenCycle 1, Single Dose860.3 ng•hr/mLGeometric Coefficient of Variation 52
PF-06647020 1.25 mg/kg (Q3W Regimen)AUCtau for PF-06380101 - Q2W RegimenCycle 1, Single Dose740.5 ng•hr/mLGeometric Coefficient of Variation 62
PF-06647020 1.25 mg/kg (Q3W Regimen)AUCtau for PF-06380101 - Q2W RegimenCycle 3, Multiple Dose589.8 ng•hr/mLGeometric Coefficient of Variation 33
Secondary

AUCtau for PF-06380101 - Q3W Regimen

Tau refers to the dosing interval and it equals to 504 hours for the Q3W dosing. AUCtau is the area under the concentration-time profile from time 0 to time tau. AUCtau for PF-06380101 was determined using linear/log trapezoidal method.

Time frame: pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 4 (21 days cycle).

Population: All participants enrolled in Q3W regimen (except DDI sub-study) who received at least 1 dose of study treatment and had sufficient information to estimate at least 1 of the PK parameters of interest.

ArmMeasureGroupValue (GEOMETRIC_MEAN)Dispersion
PF-06647020 0.2 mg/kg(Q3W Regimen)AUCtau for PF-06380101 - Q3W RegimenCycle 4, Multiple DoseNA nanogram•hour/milliliter (ng•hr/mL)
PF-06647020 0.2 mg/kg(Q3W Regimen)AUCtau for PF-06380101 - Q3W RegimenCycle 1, Single DoseNA nanogram•hour/milliliter (ng•hr/mL)
PF-06647020 0.5 mg/kg (Q3W Regimen)AUCtau for PF-06380101 - Q3W RegimenCycle 1, Single DoseNA nanogram•hour/milliliter (ng•hr/mL)
PF-06647020 1.25 mg/kg (Q3W Regimen)AUCtau for PF-06380101 - Q3W RegimenCycle 1, Single DoseNA nanogram•hour/milliliter (ng•hr/mL)
PF-06647020 1.25 mg/kg (Q3W Regimen)AUCtau for PF-06380101 - Q3W RegimenCycle 4, Multiple DoseNA nanogram•hour/milliliter (ng•hr/mL)
PF-06647020 2.1 mg/kg (Q3W Regimen)AUCtau for PF-06380101 - Q3W RegimenCycle 1, Single Dose844.6 nanogram•hour/milliliter (ng•hr/mL)Geometric Coefficient of Variation 46
PF-06647020 2.1 mg/kg (Q3W Regimen)AUCtau for PF-06380101 - Q3W RegimenCycle 4, Multiple Dose418.3 nanogram•hour/milliliter (ng•hr/mL)Geometric Coefficient of Variation 106
PF-06647020 2.8 mg/kg (Q3W Regimen)AUCtau for PF-06380101 - Q3W RegimenCycle 1, Single Dose803.9 nanogram•hour/milliliter (ng•hr/mL)Geometric Coefficient of Variation 68
PF-06647020 2.8 mg/kg (Q3W Regimen)AUCtau for PF-06380101 - Q3W RegimenCycle 4, Multiple Dose647.9 nanogram•hour/milliliter (ng•hr/mL)Geometric Coefficient of Variation 46
PF-06647020 3.7 mg/kg (Q3W Regimen)AUCtau for PF-06380101 - Q3W RegimenCycle 4, Multiple DoseNA nanogram•hour/milliliter (ng•hr/mL)
PF-06647020 3.7 mg/kg (Q3W Regimen)AUCtau for PF-06380101 - Q3W RegimenCycle 1, Single Dose1022 nanogram•hour/milliliter (ng•hr/mL)Geometric Coefficient of Variation 78
Secondary

AUCtau for PF-06647020 - Q2W Regimen

Tau refers to the dosing interval and it equals to 336 hours for the Q2W dosing. AUCtau is the area under the concentration-time profile from time 0 to time tau. AUCtau for PF-06647020 was determined using linear/log trapezoidal method.

Time frame: pre-dose, end of infusion, 4, 24, 72, 168 hours post-dose, Day 15 (pre-dose, end of infusion) for Cycle 1 and Cycle 3 (28 days cycle).

Population: All participants enrolled in Q2W regimen who received at least 1 dose of study treatment and had sufficient information to estimate at least 1 of the PK parameters of interest.

ArmMeasureGroupValue (GEOMETRIC_MEAN)Dispersion
PF-06647020 0.2 mg/kg(Q3W Regimen)AUCtau for PF-06647020 - Q2W RegimenCycle 1, Single Dose3627 µg•hr/mLGeometric Coefficient of Variation 62
PF-06647020 0.2 mg/kg(Q3W Regimen)AUCtau for PF-06647020 - Q2W RegimenCycle 3, Multiple DoseNA µg•hr/mL
PF-06647020 0.5 mg/kg (Q3W Regimen)AUCtau for PF-06647020 - Q2W RegimenCycle 1, Single Dose6541 µg•hr/mLGeometric Coefficient of Variation 38
PF-06647020 0.5 mg/kg (Q3W Regimen)AUCtau for PF-06647020 - Q2W RegimenCycle 3, Multiple Dose9858 µg•hr/mLGeometric Coefficient of Variation 21
PF-06647020 1.25 mg/kg (Q3W Regimen)AUCtau for PF-06647020 - Q2W RegimenCycle 1, Single Dose6319 µg•hr/mLGeometric Coefficient of Variation 45
PF-06647020 1.25 mg/kg (Q3W Regimen)AUCtau for PF-06647020 - Q2W RegimenCycle 3, Multiple Dose6933 µg•hr/mLGeometric Coefficient of Variation 43
Secondary

Clearance (CL) for PF-06647020 - Q3W Regimen

Clearance (CL) is a quantitative measure of the rate at which a drug substance is removed from the body. Clearance for PF-06647020 was calculated as dose/AUCinf for single dose and dose/AUCtau for multiple dose, where AUCinf was the area under the serum concentration-time profile from time 0 extrapolated to infinite time and AUCtau was the area under the concentration-time profile from time 0 to time tau (tau equals to 504 hours for the Q3W dosing).

Time frame: pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 4 (21 days cycle).

Population: All participants enrolled in Q3W regimen (except DDI sub-study) who received at least 1 dose of study treatment and had sufficient information to estimate at least 1 of the PK parameters of interest.

ArmMeasureGroupValue (GEOMETRIC_MEAN)Dispersion
PF-06647020 0.2 mg/kg(Q3W Regimen)Clearance (CL) for PF-06647020 - Q3W RegimenCycle 4, Multiple DoseNA Liter/hour (L/hr)
PF-06647020 0.2 mg/kg(Q3W Regimen)Clearance (CL) for PF-06647020 - Q3W RegimenCycle 1, Single DoseNA Liter/hour (L/hr)
PF-06647020 0.5 mg/kg (Q3W Regimen)Clearance (CL) for PF-06647020 - Q3W RegimenCycle 1, Single DoseNA Liter/hour (L/hr)
PF-06647020 1.25 mg/kg (Q3W Regimen)Clearance (CL) for PF-06647020 - Q3W RegimenCycle 1, Single DoseNA Liter/hour (L/hr)
PF-06647020 1.25 mg/kg (Q3W Regimen)Clearance (CL) for PF-06647020 - Q3W RegimenCycle 4, Multiple DoseNA Liter/hour (L/hr)
PF-06647020 2.1 mg/kg (Q3W Regimen)Clearance (CL) for PF-06647020 - Q3W RegimenCycle 1, Single Dose0.03464 Liter/hour (L/hr)Geometric Coefficient of Variation 27
PF-06647020 2.1 mg/kg (Q3W Regimen)Clearance (CL) for PF-06647020 - Q3W RegimenCycle 4, Multiple Dose0.03640 Liter/hour (L/hr)Geometric Coefficient of Variation 42
PF-06647020 2.8 mg/kg (Q3W Regimen)Clearance (CL) for PF-06647020 - Q3W RegimenCycle 1, Single Dose0.03956 Liter/hour (L/hr)Geometric Coefficient of Variation 60
PF-06647020 2.8 mg/kg (Q3W Regimen)Clearance (CL) for PF-06647020 - Q3W RegimenCycle 4, Multiple Dose0.03121 Liter/hour (L/hr)Geometric Coefficient of Variation 60
PF-06647020 3.7 mg/kg (Q3W Regimen)Clearance (CL) for PF-06647020 - Q3W RegimenCycle 4, Multiple DoseNA Liter/hour (L/hr)
PF-06647020 3.7 mg/kg (Q3W Regimen)Clearance (CL) for PF-06647020 - Q3W RegimenCycle 1, Single Dose0.03694 Liter/hour (L/hr)Geometric Coefficient of Variation 72
Secondary

CL for PF-06647020 - Q2W Regimen

Clearance (CL) is a quantitative measure of the rate at which a drug substance is removed from the body. Clearance for PF-06647020 was calculated as dose/AUCinf for single dose and dose/AUCtau for multiple dose, where AUCinf was the area under the serum concentration-time profile from time 0 extrapolated to infinite time and AUCtau was the area under the concentration-time profile from time 0 to time tau (tau equals to 336 hours for the Q2W dosing).

Time frame: pre-dose, end of infusion, 4, 24, 72, 168 hours post-dose, Day 15 (pre-dose, end of infusion) for Cycle 1 and Cycle 3 (28 days cycle).

Population: All participants enrolled in Q2W regimen who received at least 1 dose of study treatment and had sufficient information to estimate at least 1 of the PK parameters of interest.

ArmMeasureGroupValue (GEOMETRIC_MEAN)Dispersion
PF-06647020 0.2 mg/kg(Q3W Regimen)CL for PF-06647020 - Q2W RegimenCycle 1, Single DoseNA L/hr
PF-06647020 0.2 mg/kg(Q3W Regimen)CL for PF-06647020 - Q2W RegimenCycle 3, Multiple DoseNA L/hr
PF-06647020 0.5 mg/kg (Q3W Regimen)CL for PF-06647020 - Q2W RegimenCycle 1, Single Dose0.03075 L/hrGeometric Coefficient of Variation 49
PF-06647020 0.5 mg/kg (Q3W Regimen)CL for PF-06647020 - Q2W RegimenCycle 3, Multiple Dose0.02044 L/hrGeometric Coefficient of Variation 25
PF-06647020 1.25 mg/kg (Q3W Regimen)CL for PF-06647020 - Q2W RegimenCycle 1, Single Dose0.03238 L/hrGeometric Coefficient of Variation 39
PF-06647020 1.25 mg/kg (Q3W Regimen)CL for PF-06647020 - Q2W RegimenCycle 3, Multiple Dose0.02688 L/hrGeometric Coefficient of Variation 35
Secondary

Cmax(dn) for hu6M024 mAb [DDI Sub-Study]

Cmax is maximum observed serum concentration. Cmax(dn) was defined as dose normalized Cmax and calculated as Cmax/dose.

Time frame: pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 2 (21 days cycle).

Population: Participants who participated in the DDI sub-study, and had at least one of the study required PK samples.

ArmMeasureValue (GEOMETRIC_MEAN)Dispersion
PF-06647020 0.2 mg/kg(Q3W Regimen)Cmax(dn) for hu6M024 mAb [DDI Sub-Study]0.4378 µg/mL/mgGeometric Coefficient of Variation 59
PF-06647020 0.5 mg/kg (Q3W Regimen)Cmax(dn) for hu6M024 mAb [DDI Sub-Study]0.3885 µg/mL/mgGeometric Coefficient of Variation 37
Comparison: Test: PF-06647020 1.4 mg/kg + Fluconazole(Q3W-DDI) group; Reference: PF-06647020 2.8 mg/kg (Q3W-DDI) group.p-value: 0.567890% CI: [62.24, 126.56]ANOVA
Secondary

Cmax(dn) for PF-06380101 [DDI Sub-Study]

Cmax is maximum observed serum concentration. Cmax(dn) was defined as dose normalized Cmax and calculated as Cmax/dose.

Time frame: pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 2 (21 days cycle).

Population: Participants who participated in the DDI sub-study, and had at least one of the study required PK samples.

ArmMeasureValue (GEOMETRIC_MEAN)Dispersion
PF-06647020 0.2 mg/kg(Q3W Regimen)Cmax(dn) for PF-06380101 [DDI Sub-Study]0.04336 ng/mL/mgGeometric Coefficient of Variation 113
PF-06647020 0.5 mg/kg (Q3W Regimen)Cmax(dn) for PF-06380101 [DDI Sub-Study]0.04436 ng/mL/mgGeometric Coefficient of Variation 118
Comparison: Test: PF-06647020 1.4 mg/kg + Fluconazole(Q3W-DDI) group; Reference: PF-06647020 2.8 mg/kg (Q3W-DDI) group.p-value: 0.955390% CI: [51.08, 204.9]ANOVA
Secondary

Cmax for hu6M024 mAb -Q2W Regimen

Cmax is maximum observed serum concentration. Cmax for hu6M024 mAb was observed directly from data.

Time frame: pre-dose, end of infusion, 4, 24, 72, 168 hours post-dose, Day 15 (pre-dose, end of infusion) for Cycle 1 and Cycle 3 (28 days cycle).

Population: All participants enrolled in Q2W regimen who received at least 1 dose of study treatment and had sufficient information to estimate at least 1 of the PK parameters of interest.

ArmMeasureGroupValue (GEOMETRIC_MEAN)Dispersion
PF-06647020 0.2 mg/kg(Q3W Regimen)Cmax for hu6M024 mAb -Q2W RegimenCycle 1, Single Dose72.04 µg/mLGeometric Coefficient of Variation 23
PF-06647020 0.2 mg/kg(Q3W Regimen)Cmax for hu6M024 mAb -Q2W RegimenCycle 3, Multiple DoseNA µg/mL
PF-06647020 0.5 mg/kg (Q3W Regimen)Cmax for hu6M024 mAb -Q2W RegimenCycle 1, Single Dose102.1 µg/mLGeometric Coefficient of Variation 38
PF-06647020 0.5 mg/kg (Q3W Regimen)Cmax for hu6M024 mAb -Q2W RegimenCycle 3, Multiple Dose106.6 µg/mLGeometric Coefficient of Variation 37
PF-06647020 1.25 mg/kg (Q3W Regimen)Cmax for hu6M024 mAb -Q2W RegimenCycle 1, Single Dose86.26 µg/mLGeometric Coefficient of Variation 27
PF-06647020 1.25 mg/kg (Q3W Regimen)Cmax for hu6M024 mAb -Q2W RegimenCycle 3, Multiple Dose89.66 µg/mLGeometric Coefficient of Variation 33
Secondary

Cmax for hu6M024 mAb - Q3W Regimen

Cmax is maximum observed serum concentration. Cmax for hu6M024 mAb was observed directly from data.

Time frame: pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 4 (21 days cycle).

Population: All participants enrolled in Q3W regimen (except DDI sub-study) who received at least 1 dose of study treatment and had sufficient information to estimate at least 1 of the PK parameters of interest.

ArmMeasureGroupValue (GEOMETRIC_MEAN)Dispersion
PF-06647020 0.2 mg/kg(Q3W Regimen)Cmax for hu6M024 mAb - Q3W RegimenCycle 1, Single DoseNA µg/mL
PF-06647020 0.2 mg/kg(Q3W Regimen)Cmax for hu6M024 mAb - Q3W RegimenCycle 4, Multiple DoseNA µg/mL
PF-06647020 0.5 mg/kg (Q3W Regimen)Cmax for hu6M024 mAb - Q3W RegimenCycle 1, Single DoseNA µg/mL
PF-06647020 1.25 mg/kg (Q3W Regimen)Cmax for hu6M024 mAb - Q3W RegimenCycle 1, Single DoseNA µg/mL
PF-06647020 1.25 mg/kg (Q3W Regimen)Cmax for hu6M024 mAb - Q3W RegimenCycle 4, Multiple DoseNA µg/mL
PF-06647020 2.1 mg/kg (Q3W Regimen)Cmax for hu6M024 mAb - Q3W RegimenCycle 4, Multiple Dose77.76 µg/mLGeometric Coefficient of Variation 76
PF-06647020 2.1 mg/kg (Q3W Regimen)Cmax for hu6M024 mAb - Q3W RegimenCycle 1, Single Dose83.33 µg/mLGeometric Coefficient of Variation 20
PF-06647020 2.8 mg/kg (Q3W Regimen)Cmax for hu6M024 mAb - Q3W RegimenCycle 1, Single Dose84.83 µg/mLGeometric Coefficient of Variation 43
PF-06647020 2.8 mg/kg (Q3W Regimen)Cmax for hu6M024 mAb - Q3W RegimenCycle 4, Multiple Dose82.33 µg/mLGeometric Coefficient of Variation 40
PF-06647020 3.7 mg/kg (Q3W Regimen)Cmax for hu6M024 mAb - Q3W RegimenCycle 4, Multiple DoseNA µg/mL
PF-06647020 3.7 mg/kg (Q3W Regimen)Cmax for hu6M024 mAb - Q3W RegimenCycle 1, Single Dose99.37 µg/mLGeometric Coefficient of Variation 47
Secondary

Cmax for PF-06380101 - Q2W Regimen

Cmax is maximum observed serum concentration. Cmax for PF-06380101 was observed directly from data.

Time frame: pre-dose, end of infusion, 4, 24, 72, 168 hours post-dose, Day 15 (pre-dose, end of infusion) for Cycle 1 and Cycle 3 (28 days cycle).

Population: All participants enrolled in Q2W regimen who received at least 1 dose of study treatment and had sufficient information to estimate at least 1 of the PK parameters of interest.

ArmMeasureGroupValue (GEOMETRIC_MEAN)Dispersion
PF-06647020 0.2 mg/kg(Q3W Regimen)Cmax for PF-06380101 - Q2W RegimenCycle 1, Single Dose6.084 ng/mLGeometric Coefficient of Variation 59
PF-06647020 0.2 mg/kg(Q3W Regimen)Cmax for PF-06380101 - Q2W RegimenCycle 3, Multiple DoseNA ng/mL
PF-06647020 0.5 mg/kg (Q3W Regimen)Cmax for PF-06380101 - Q2W RegimenCycle 1, Single Dose6.665 ng/mLGeometric Coefficient of Variation 49
PF-06647020 0.5 mg/kg (Q3W Regimen)Cmax for PF-06380101 - Q2W RegimenCycle 3, Multiple Dose4.857 ng/mLGeometric Coefficient of Variation 66
PF-06647020 1.25 mg/kg (Q3W Regimen)Cmax for PF-06380101 - Q2W RegimenCycle 1, Single Dose5.779 ng/mLGeometric Coefficient of Variation 59
PF-06647020 1.25 mg/kg (Q3W Regimen)Cmax for PF-06380101 - Q2W RegimenCycle 3, Multiple Dose4.248 ng/mLGeometric Coefficient of Variation 34
Secondary

Cmax for PF-06380101 - Q3W Regimen

Cmax is maximum observed serum concentration. Cmax for PF-06380101 was observed directly from data.

Time frame: pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 4 (21 days cycle).

Population: All participants enrolled in Q3W regimen (except DDI sub-study) who received at least 1 dose of study treatment and had sufficient information to estimate at least 1 of the PK parameters of interest.

ArmMeasureGroupValue (GEOMETRIC_MEAN)Dispersion
PF-06647020 0.2 mg/kg(Q3W Regimen)Cmax for PF-06380101 - Q3W RegimenCycle 1, Single DoseNA nanogram/milliliter (ng/mL)
PF-06647020 0.2 mg/kg(Q3W Regimen)Cmax for PF-06380101 - Q3W RegimenCycle 4, Multiple DoseNA nanogram/milliliter (ng/mL)
PF-06647020 0.5 mg/kg (Q3W Regimen)Cmax for PF-06380101 - Q3W RegimenCycle 1, Single DoseNA nanogram/milliliter (ng/mL)
PF-06647020 1.25 mg/kg (Q3W Regimen)Cmax for PF-06380101 - Q3W RegimenCycle 1, Single DoseNA nanogram/milliliter (ng/mL)
PF-06647020 1.25 mg/kg (Q3W Regimen)Cmax for PF-06380101 - Q3W RegimenCycle 4, Multiple DoseNA nanogram/milliliter (ng/mL)
PF-06647020 2.1 mg/kg (Q3W Regimen)Cmax for PF-06380101 - Q3W RegimenCycle 1, Single Dose7.156 nanogram/milliliter (ng/mL)Geometric Coefficient of Variation 39
PF-06647020 2.1 mg/kg (Q3W Regimen)Cmax for PF-06380101 - Q3W RegimenCycle 4, Multiple Dose3.379 nanogram/milliliter (ng/mL)Geometric Coefficient of Variation 84
PF-06647020 2.8 mg/kg (Q3W Regimen)Cmax for PF-06380101 - Q3W RegimenCycle 1, Single Dose6.934 nanogram/milliliter (ng/mL)Geometric Coefficient of Variation 69
PF-06647020 2.8 mg/kg (Q3W Regimen)Cmax for PF-06380101 - Q3W RegimenCycle 4, Multiple Dose5.746 nanogram/milliliter (ng/mL)Geometric Coefficient of Variation 60
PF-06647020 3.7 mg/kg (Q3W Regimen)Cmax for PF-06380101 - Q3W RegimenCycle 4, Multiple DoseNA nanogram/milliliter (ng/mL)
PF-06647020 3.7 mg/kg (Q3W Regimen)Cmax for PF-06380101 - Q3W RegimenCycle 1, Single Dose7.660 nanogram/milliliter (ng/mL)Geometric Coefficient of Variation 47
Secondary

Cmax for PF-06647020 -Q2W Regimen

Cmax is maximum observed serum concentration. Cmax for PF-06647020 was observed directly from data.

Time frame: pre-dose, end of infusion, 4, 24, 72, 168 hours post-dose, Day 15 (pre-dose, end of infusion) for Cycle 1 and Cycle 3 (28 days cycle).

Population: All participants enrolled in Q2W regimen who received at least 1 dose of study treatment and had sufficient information to estimate at least 1 of the PK parameters of interest.

ArmMeasureGroupValue (GEOMETRIC_MEAN)Dispersion
PF-06647020 0.2 mg/kg(Q3W Regimen)Cmax for PF-06647020 -Q2W RegimenCycle 1, Single Dose97.79 µg/mLGeometric Coefficient of Variation 14
PF-06647020 0.2 mg/kg(Q3W Regimen)Cmax for PF-06647020 -Q2W RegimenCycle 3, Multiple DoseNA µg/mL
PF-06647020 0.5 mg/kg (Q3W Regimen)Cmax for PF-06647020 -Q2W RegimenCycle 1, Single Dose99.69 µg/mLGeometric Coefficient of Variation 32
PF-06647020 0.5 mg/kg (Q3W Regimen)Cmax for PF-06647020 -Q2W RegimenCycle 3, Multiple Dose114.7 µg/mLGeometric Coefficient of Variation 26
PF-06647020 1.25 mg/kg (Q3W Regimen)Cmax for PF-06647020 -Q2W RegimenCycle 1, Single Dose90.28 µg/mLGeometric Coefficient of Variation 32
PF-06647020 1.25 mg/kg (Q3W Regimen)Cmax for PF-06647020 -Q2W RegimenCycle 3, Multiple Dose81.91 µg/mLGeometric Coefficient of Variation 34
Secondary

Disease Control Rate - Q2W Regimen

The disease control rate (DCR) was defined as the percentage of participants with a confirmed CR, PR or SD according to the appropriate analysis set. CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis \<10 mm). No new lesions. PR was defined as \>=30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.

Time frame: Baseline, every 8 weeks from the start of study treatment until disease progression, death or withdrawal from treatment (approximately 19 months).

Population: Participants enrolled in Q2W regimen with measurable disease (NSCLC, OVCA) who had received at least 1 dose of study medication and had a baseline tumor assessment.

ArmMeasureValue (NUMBER)
PF-06647020 0.2 mg/kg(Q3W Regimen)Disease Control Rate - Q2W Regimen50 Percentage of participants
PF-06647020 0.5 mg/kg (Q3W Regimen)Disease Control Rate - Q2W Regimen84.2 Percentage of participants
Secondary

Disease Control Rate - Q3W Regimen

The disease control rate (DCR) was defined as the percentage of participants with a confirmed CR, PR, non-CR/non-PD or stable disease (SD) according to the appropriate analysis set. CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis \<10 mm). No new lesions. PR was defined as \>=30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.

Time frame: Baseline, every 6 weeks from the start of treatment until disease progression, death or withdrawal from treatment (approximately 32 months).

Population: Participants enrolled in Q3W regimen with measurable disease (NSCLC, OVCA, TNBC) who had received at least 1 dose of study medication and had a baseline tumor assessment.

ArmMeasureValue (NUMBER)
PF-06647020 0.2 mg/kg(Q3W Regimen)Disease Control Rate - Q3W Regimen56.0 Percentage of participants
PF-06647020 0.5 mg/kg (Q3W Regimen)Disease Control Rate - Q3W Regimen72.7 Percentage of participants
PF-06647020 1.25 mg/kg (Q3W Regimen)Disease Control Rate - Q3W Regimen48.3 Percentage of participants
Secondary

Dose Normalized AUCinf [AUCinf(dn)] for PF-06647020 [DDI Sub-Study]

AUCinf is the area under the serum concentration-time profile from time 0 extrapolated to infinite time. AUCinf(dn) was defined as dose normalized AUCinf and calculated as AUCinf/dose.

Time frame: pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 2 (21 days cycle).

Population: The drug-drug interaction (DDI) sub-study was determined to evaluate the effect of multiple dose fluconazole on the PK of PF-06380101 (payload), when fluconazole was co-administered with PF-06647020. The analysis population included participants who participated in the DDI sub-study, and had at least one of the study required PK samples.

ArmMeasureValue (GEOMETRIC_MEAN)Dispersion
PF-06647020 0.2 mg/kg(Q3W Regimen)Dose Normalized AUCinf [AUCinf(dn)] for PF-06647020 [DDI Sub-Study]29.56 µg•hr/mL/mgGeometric Coefficient of Variation 46
PF-06647020 0.5 mg/kg (Q3W Regimen)Dose Normalized AUCinf [AUCinf(dn)] for PF-06647020 [DDI Sub-Study]23.47 µg•hr/mL/mgGeometric Coefficient of Variation 53
Comparison: Test: PF-06647020 1.4 mg/kg + Fluconazole(Q3W-DDI) group; Reference: PF-06647020 2.8 mg/kg (Q3W-DDI) group.p-value: 0.310590% CI: [54.01, 116.65]ANOVA
Secondary

Dose Normalized AUClast [AUClast(dn)] for PF-06647020 [DDI Sub-Study]

AUClast is the area under the serum concentration-time profile from time 0 to the time of the last quantifiable concentration. AUClast(dn) was defined as dose normalized AUClast and calculated as AUClast/dose.

Time frame: pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 2 (21 days cycle).

Population: Participants who participated in the DDI sub-study, and had at least one of the study required PK samples.

ArmMeasureValue (GEOMETRIC_MEAN)Dispersion
PF-06647020 0.2 mg/kg(Q3W Regimen)Dose Normalized AUClast [AUClast(dn)] for PF-06647020 [DDI Sub-Study]31.51 µg•hr/mL/mgGeometric Coefficient of Variation 51
PF-06647020 0.5 mg/kg (Q3W Regimen)Dose Normalized AUClast [AUClast(dn)] for PF-06647020 [DDI Sub-Study]24.34 µg•hr/mL/mgGeometric Coefficient of Variation 50
Comparison: Test: PF-06647020 1.4 mg/kg + Fluconazole(Q3W-DDI) group; Reference: PF-06647020 2.8 mg/kg (Q3W-DDI) group.p-value: 0.231690% CI: [53.8, 110.87]ANOVA
Secondary

Dose Normalized AUCtau [AUCtau(dn)] for PF-06647020 [DDI Sub-Study]

AUCtau is the area under the concentration-time profile from time 0 to time tau. AUCtau(dn) was defined as dose normalized AUCtau and calculated as AUCtau/dose.

Time frame: pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 2 (21 days cycle).

Population: Participants who participated in the DDI sub-study, and had at least one of the study required PK samples.

ArmMeasureValue (GEOMETRIC_MEAN)Dispersion
PF-06647020 0.2 mg/kg(Q3W Regimen)Dose Normalized AUCtau [AUCtau(dn)] for PF-06647020 [DDI Sub-Study]29.25 µg•hr/mL/mgGeometric Coefficient of Variation 46
PF-06647020 0.5 mg/kg (Q3W Regimen)Dose Normalized AUCtau [AUCtau(dn)] for PF-06647020 [DDI Sub-Study]24.85 µg•hr/mL/mgGeometric Coefficient of Variation 48
Comparison: Test: PF-06647020 1.4 mg/kg + Fluconazole(Q3W-DDI) group; Reference: PF-06647020 2.8 mg/kg (Q3W-DDI) group.p-value: 0.426490% CI: [60.05, 120.22]ANOVA
Secondary

Dose Normalized Cmax [Cmax(dn)] for PF-06647020 [DDI Sub-Study]

Cmax is maximum observed serum concentration. Cmax(dn) was defined as dose normalized Cmax and calculated as Cmax/dose.

Time frame: pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 2 (21 days cycle).

Population: Participants who participated in the DDI sub-study, and had at least one of the study required PK samples.

ArmMeasureValue (GEOMETRIC_MEAN)Dispersion
PF-06647020 0.2 mg/kg(Q3W Regimen)Dose Normalized Cmax [Cmax(dn)] for PF-06647020 [DDI Sub-Study]0.5010 µg/mL/mgGeometric Coefficient of Variation 49
PF-06647020 0.5 mg/kg (Q3W Regimen)Dose Normalized Cmax [Cmax(dn)] for PF-06647020 [DDI Sub-Study]0.4425 µg/mL/mgGeometric Coefficient of Variation 39
Comparison: Test: PF-06647020 1.4 mg/kg + Fluconazole(Q3W-DDI) group; Reference: PF-06647020 2.8 mg/kg (Q3W-DDI) group.p-value: 0.512390% CI: [64.03, 121.82]ANOVA
Secondary

Duration of Response - Q2W Regimen

For participants with an objective response, duration of response (DoR) was the time from first documentation of PR or CR to date of first documentation of PD or death due to any cause. CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis \<10 mm). No new lesions. PR was defined as \>=30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions. PD was defined as at least a 20% increase (including an absolute increase of at least 5 mm) in the sum of diameters of target lesions, taking as reference the smallest sum on study and/or unequivocal progression of existing non-target lesions and/or appearance of one or more new lesions.

Time frame: Baseline, every 8 weeks from the start of study treatment until disease progression, death or withdrawal from treatment (approximately 19 months).

Population: Participants enrolled in Q2W regimen with measurable disease (NSCLC, OVCA) who had received at least 1 dose of study medication and had a baseline tumor assessment. DoR was only for the subset participants with an objective response.

ArmMeasureValue (MEDIAN)
PF-06647020 0.2 mg/kg(Q3W Regimen)Duration of Response - Q2W RegimenNA month
PF-06647020 0.5 mg/kg (Q3W Regimen)Duration of Response - Q2W Regimen6.5 month
Secondary

Duration of Response - Q3W Regimen

Duration of response (DoR) was the time from first documentation of PR or CR to date of first documentation of progressive disease (PD) or death due to any cause. CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis \<10 mm). No new lesions. PR was defined as \>=30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions. PD was defined as at least a 20% increase (including an absolute increase of at least 5 mm) in the sum of diameters of target lesions, taking as reference the smallest sum on study and/or unequivocal progression of existing non-target lesions and/or appearance of one or more new lesions.

Time frame: Baseline, every 6 weeks from the start of treatment until disease progression, death or withdrawal from treatment (approximately 32 months).

Population: Participants enrolled in Q3W regimen with measurable disease (NSCLC, OVCA, TNBC) who had received at least 1 dose of study medication and had a baseline tumor assessment. DoR was only for the subset participants with an objective response.

ArmMeasureValue (MEDIAN)
PF-06647020 0.2 mg/kg(Q3W Regimen)Duration of Response - Q3W Regimen5.7 month
PF-06647020 0.5 mg/kg (Q3W Regimen)Duration of Response - Q3W Regimen4.2 month
PF-06647020 1.25 mg/kg (Q3W Regimen)Duration of Response - Q3W Regimen4.3 month
Secondary

Maximum Observed Serum Concentration (Cmax) for PF-06647020 -Q3W Regimen

Cmax is maximum observed serum concentration. Cmax for PF-06647020 was observed directly from data.

Time frame: pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 4 (21 days cycle).

Population: All participants enrolled in Q3W regimen (except DDI sub-study) who received at least 1 dose of study treatment and had sufficient information to estimate at least 1 of the PK parameters of interest.

ArmMeasureGroupValue (GEOMETRIC_MEAN)Dispersion
PF-06647020 0.2 mg/kg(Q3W Regimen)Maximum Observed Serum Concentration (Cmax) for PF-06647020 -Q3W RegimenCycle 4, Multiple DoseNA microgram/milliliter (µg/mL)
PF-06647020 0.2 mg/kg(Q3W Regimen)Maximum Observed Serum Concentration (Cmax) for PF-06647020 -Q3W RegimenCycle 1, Single DoseNA microgram/milliliter (µg/mL)
PF-06647020 0.5 mg/kg (Q3W Regimen)Maximum Observed Serum Concentration (Cmax) for PF-06647020 -Q3W RegimenCycle 1, Single DoseNA microgram/milliliter (µg/mL)
PF-06647020 1.25 mg/kg (Q3W Regimen)Maximum Observed Serum Concentration (Cmax) for PF-06647020 -Q3W RegimenCycle 1, Single DoseNA microgram/milliliter (µg/mL)
PF-06647020 1.25 mg/kg (Q3W Regimen)Maximum Observed Serum Concentration (Cmax) for PF-06647020 -Q3W RegimenCycle 4, Multiple DoseNA microgram/milliliter (µg/mL)
PF-06647020 2.1 mg/kg (Q3W Regimen)Maximum Observed Serum Concentration (Cmax) for PF-06647020 -Q3W RegimenCycle 1, Single Dose65.77 microgram/milliliter (µg/mL)Geometric Coefficient of Variation 25
PF-06647020 2.1 mg/kg (Q3W Regimen)Maximum Observed Serum Concentration (Cmax) for PF-06647020 -Q3W RegimenCycle 4, Multiple Dose55.41 microgram/milliliter (µg/mL)Geometric Coefficient of Variation 53
PF-06647020 2.8 mg/kg (Q3W Regimen)Maximum Observed Serum Concentration (Cmax) for PF-06647020 -Q3W RegimenCycle 1, Single Dose79.77 microgram/milliliter (µg/mL)Geometric Coefficient of Variation 45
PF-06647020 2.8 mg/kg (Q3W Regimen)Maximum Observed Serum Concentration (Cmax) for PF-06647020 -Q3W RegimenCycle 4, Multiple Dose92.94 microgram/milliliter (µg/mL)Geometric Coefficient of Variation 50
PF-06647020 3.7 mg/kg (Q3W Regimen)Maximum Observed Serum Concentration (Cmax) for PF-06647020 -Q3W RegimenCycle 4, Multiple DoseNA microgram/milliliter (µg/mL)
PF-06647020 3.7 mg/kg (Q3W Regimen)Maximum Observed Serum Concentration (Cmax) for PF-06647020 -Q3W RegimenCycle 1, Single Dose96.11 microgram/milliliter (µg/mL)Geometric Coefficient of Variation 47
Secondary

Number of Participants With ADA and NAb of PF-06647020 - Q2W Regimen

To evaluate the immunogenicity as measured by presence of ADA and NAb in participants treated with PF-06647020.

Time frame: 2 hours before the first dose up to 30 days after the last dose (approximately 18 months).

Population: All participants enrolled in Q2W regimen who received at least 1 dose of study treatment and had at least 1 ADA sample collected.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
PF-06647020 0.2 mg/kg(Q3W Regimen)Number of Participants With ADA and NAb of PF-06647020 - Q2W RegimenOverall incidence of ADA1 Participants
PF-06647020 0.2 mg/kg(Q3W Regimen)Number of Participants With ADA and NAb of PF-06647020 - Q2W RegimenOverall incidence of NAb1 Participants
PF-06647020 0.5 mg/kg (Q3W Regimen)Number of Participants With ADA and NAb of PF-06647020 - Q2W RegimenOverall incidence of ADA0 Participants
PF-06647020 0.5 mg/kg (Q3W Regimen)Number of Participants With ADA and NAb of PF-06647020 - Q2W RegimenOverall incidence of NAb0 Participants
PF-06647020 1.25 mg/kg (Q3W Regimen)Number of Participants With ADA and NAb of PF-06647020 - Q2W RegimenOverall incidence of ADA0 Participants
PF-06647020 1.25 mg/kg (Q3W Regimen)Number of Participants With ADA and NAb of PF-06647020 - Q2W RegimenOverall incidence of NAb0 Participants
Secondary

Number of Participants With Anti-Drug Antibodies (ADA) and Neutralizing Antibody (NAb) of PF-06647020 - Q3W Regimen

To evaluate the immunogenicity as measured by presence of ADA and NAb in participants treated with PF-06647020.

Time frame: Prior to the start of treatment on Day 1 of Cycle 1 up to end of treatment (approximately 31 months).

Population: All participants enrolled in Q3W regimen who received at least 1 dose of study treatment and had at least 1 ADA sample collected.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
PF-06647020 0.2 mg/kg(Q3W Regimen)Number of Participants With Anti-Drug Antibodies (ADA) and Neutralizing Antibody (NAb) of PF-06647020 - Q3W RegimenOverall incidence of ADA1 Participants
PF-06647020 0.2 mg/kg(Q3W Regimen)Number of Participants With Anti-Drug Antibodies (ADA) and Neutralizing Antibody (NAb) of PF-06647020 - Q3W RegimenOverall incidence of NAb1 Participants
PF-06647020 0.5 mg/kg (Q3W Regimen)Number of Participants With Anti-Drug Antibodies (ADA) and Neutralizing Antibody (NAb) of PF-06647020 - Q3W RegimenOverall incidence of ADA0 Participants
PF-06647020 0.5 mg/kg (Q3W Regimen)Number of Participants With Anti-Drug Antibodies (ADA) and Neutralizing Antibody (NAb) of PF-06647020 - Q3W RegimenOverall incidence of NAb0 Participants
PF-06647020 1.25 mg/kg (Q3W Regimen)Number of Participants With Anti-Drug Antibodies (ADA) and Neutralizing Antibody (NAb) of PF-06647020 - Q3W RegimenOverall incidence of ADA0 Participants
PF-06647020 1.25 mg/kg (Q3W Regimen)Number of Participants With Anti-Drug Antibodies (ADA) and Neutralizing Antibody (NAb) of PF-06647020 - Q3W RegimenOverall incidence of NAb0 Participants
PF-06647020 2.1 mg/kg (Q3W Regimen)Number of Participants With Anti-Drug Antibodies (ADA) and Neutralizing Antibody (NAb) of PF-06647020 - Q3W RegimenOverall incidence of ADA0 Participants
PF-06647020 2.1 mg/kg (Q3W Regimen)Number of Participants With Anti-Drug Antibodies (ADA) and Neutralizing Antibody (NAb) of PF-06647020 - Q3W RegimenOverall incidence of NAb0 Participants
PF-06647020 2.8 mg/kg (Q3W Regimen)Number of Participants With Anti-Drug Antibodies (ADA) and Neutralizing Antibody (NAb) of PF-06647020 - Q3W RegimenOverall incidence of ADA10 Participants
PF-06647020 2.8 mg/kg (Q3W Regimen)Number of Participants With Anti-Drug Antibodies (ADA) and Neutralizing Antibody (NAb) of PF-06647020 - Q3W RegimenOverall incidence of NAb9 Participants
PF-06647020 3.7 mg/kg (Q3W Regimen)Number of Participants With Anti-Drug Antibodies (ADA) and Neutralizing Antibody (NAb) of PF-06647020 - Q3W RegimenOverall incidence of ADA0 Participants
PF-06647020 3.7 mg/kg (Q3W Regimen)Number of Participants With Anti-Drug Antibodies (ADA) and Neutralizing Antibody (NAb) of PF-06647020 - Q3W RegimenOverall incidence of NAb0 Participants
Secondary

Observed Accumulation Ratio (Rac) for PF-06647020 - Q3W Regimen

Rac is defined as observed accumulation ratio based on dose normalized AUCtau (AUCtau\[dn\]), where AUCtau is the area under the concentration-time profile from time 0 to time tau (tau equals to 504 hours for the Q3W dosing). Rac=Cycle 4 Day 1 AUCtau(dn) (multiple dose) /Cycle 1 Day 1 AUCtau(dn) (single Dose).

Time frame: pre-dose, 1, 4 hours post-dose on Day 1 of Cycle 1 and Day 1 of Cycle 4 (21 days cycle).

Population: All participants enrolled in Q3W regimen (except DDI sub-study) who received at least 1 dose of study treatment and had sufficient information to estimate at least 1 of the PK parameters of interest.

ArmMeasureValue (GEOMETRIC_MEAN)Dispersion
PF-06647020 0.2 mg/kg(Q3W Regimen)Observed Accumulation Ratio (Rac) for PF-06647020 - Q3W RegimenNA Ratio
PF-06647020 1.25 mg/kg (Q3W Regimen)Observed Accumulation Ratio (Rac) for PF-06647020 - Q3W RegimenNA Ratio
PF-06647020 2.1 mg/kg (Q3W Regimen)Observed Accumulation Ratio (Rac) for PF-06647020 - Q3W Regimen1.046 RatioGeometric Coefficient of Variation 61
PF-06647020 2.8 mg/kg (Q3W Regimen)Observed Accumulation Ratio (Rac) for PF-06647020 - Q3W Regimen1.094 RatioGeometric Coefficient of Variation 39
PF-06647020 3.7 mg/kg (Q3W Regimen)Observed Accumulation Ratio (Rac) for PF-06647020 - Q3W RegimenNA Ratio
Secondary

Percentage of Participants With Objective Response - Q2W Regimen

Percentage of participants with objective response based on assessment of CR or PR according to RECIST version 1.1. CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis \<10 mm). No new lesions. PR was defined as \>=30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions.

Time frame: Baseline, every 8 weeks from the start of study treatment until disease progression, death or withdrawal from treatment (approximately 19 months).

Population: Participants enrolled in Q2W with measurable disease (NSCLC, OVCA) who had received at least 1 dose of study medication and had a baseline tumor assessment.

ArmMeasureValue (NUMBER)
PF-06647020 0.2 mg/kg(Q3W Regimen)Percentage of Participants With Objective Response - Q2W Regimen33.3 Percentage of participants
PF-06647020 0.5 mg/kg (Q3W Regimen)Percentage of Participants With Objective Response - Q2W Regimen26.3 Percentage of participants
Secondary

Percentage of Participants With Objective Response - Q3W Regimen

Percentage of participants with objective response based on assessment of complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis \<10 mm). No new lesions. PR was defined as \>=30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions.

Time frame: Baseline, every 6 weeks from the start of treatment until disease progression, death or withdrawal from treatment (approximately 32 months).

Population: Participants enrolled in Q3W regimen with measurable disease (non-small cell lung cancer \[NSCLC\], ovarian cancer \[OVCA\], triple negative breast cancer \[TNBC\]) who had received at least 1 dose of study medication and had a baseline tumor assessment.

ArmMeasureValue (NUMBER)
PF-06647020 0.2 mg/kg(Q3W Regimen)Percentage of Participants With Objective Response - Q3W Regimen16.0 Percentage of participants
PF-06647020 0.5 mg/kg (Q3W Regimen)Percentage of Participants With Objective Response - Q3W Regimen27.3 Percentage of participants
PF-06647020 1.25 mg/kg (Q3W Regimen)Percentage of Participants With Objective Response - Q3W Regimen20.7 Percentage of participants
Secondary

Progression Free Survival - Q2W Regimen

Progression free survival (PFS) was the time from randomization date to date of first documentation of PD or death due to any cause. PD was defined as at least a 20% increase (including an absolute increase of at least 5 mm) in the sum of diameters of target lesions, taking as reference the smallest sum on study and/or unequivocal progression of existing non-target lesions and/or appearance of one or more new lesions.

Time frame: Baseline, every 8 weeks from the start of study treatment until disease progression, death or withdrawal from treatment (approximately 19 months).

Population: Participants enrolled in Q2W regimen with measurable disease (NSCLC, OVCA) who had received at least 1 dose of study medication and had a baseline tumor assessment.

ArmMeasureValue (MEDIAN)
PF-06647020 0.2 mg/kg(Q3W Regimen)Progression Free Survival - Q2W Regimen2.7 month
PF-06647020 0.5 mg/kg (Q3W Regimen)Progression Free Survival - Q2W Regimen3.8 month
Secondary

Progression Free Survival - Q3W Regimen

Progression free survival (PFS) was the time from randomization date to date of first documentation of PD or death due to any cause. PD was defined as at least a 20% increase (including an absolute increase of at least 5 mm) in the sum of diameters of target lesions, taking as reference the smallest sum on study and/or unequivocal progression of existing non-target lesions and/or appearance of one or more new lesions.

Time frame: Baseline, every 6 weeks from the start of treatment until disease progression, death or withdrawal from treatment (approximately 32 months).

Population: Participants enrolled in Q3W regimen with measurable disease (NSCLC, OVCA, TNBC) who had received at least 1 dose of study medication and had a baseline tumor assessment.

ArmMeasureValue (MEDIAN)
PF-06647020 0.2 mg/kg(Q3W Regimen)Progression Free Survival - Q3W Regimen2.9 month
PF-06647020 0.5 mg/kg (Q3W Regimen)Progression Free Survival - Q3W Regimen2.9 month
PF-06647020 1.25 mg/kg (Q3W Regimen)Progression Free Survival - Q3W Regimen1.5 month
Secondary

Rac for hu6M024 mAb - Q2W Regimen

Rac is defined as observed accumulation ratio based on dose normalized AUCtau (AUCtau\[dn\]), where AUCtau is the area under the concentration-time profile from time 0 to time tau (tau equals to 336 hours for the Q2W dosing). Rac= Cycle 3 Day 1 AUCtau(dn) (multiple dose) /Cycle 1 Day 1 AUCtau(dn) (single Dose).

Time frame: pre-dose, end of infusion, 4 hours post-dose on Day 1 of Cycle 1 and Day 1 of Cycle 3 (28 days cycle).

Population: All participants enrolled in Q2W regimen who received at least 1 dose of study treatment and had sufficient information to estimate at least 1 of the PK parameters of interest.

ArmMeasureValue (GEOMETRIC_MEAN)Dispersion
PF-06647020 0.2 mg/kg(Q3W Regimen)Rac for hu6M024 mAb - Q2W RegimenNA Ratio
PF-06647020 0.5 mg/kg (Q3W Regimen)Rac for hu6M024 mAb - Q2W Regimen1.280 RatioGeometric Coefficient of Variation 32
PF-06647020 1.25 mg/kg (Q3W Regimen)Rac for hu6M024 mAb - Q2W Regimen1.301 RatioGeometric Coefficient of Variation 35
Secondary

Rac for hu6M024 mAb - Q3W Regimen

Rac is defined as observed accumulation ratio based on dose normalized AUCtau (AUCtau\[dn\]), where AUCtau is the area under the concentration-time profile from time 0 to time tau (tau equals to 504 hours for the Q3W dosing). Rac=Cycle 4 Day 1 AUCtau(dn) (multiple dose) /Cycle 1 Day 1 AUCtau(dn) (single Dose).

Time frame: pre-dose, 1, 4 hours post-dose on Day 1 of Cycle 1 and Day 1 of Cycle 4 (21 days cycle).

Population: All participants enrolled in Q3W regimen (except DDI sub-study) who received at least 1 dose of study treatment and had sufficient information to estimate at least 1 of the PK parameters of interest.

ArmMeasureValue (GEOMETRIC_MEAN)Dispersion
PF-06647020 0.2 mg/kg(Q3W Regimen)Rac for hu6M024 mAb - Q3W RegimenNA Ratio
PF-06647020 1.25 mg/kg (Q3W Regimen)Rac for hu6M024 mAb - Q3W RegimenNA Ratio
PF-06647020 2.1 mg/kg (Q3W Regimen)Rac for hu6M024 mAb - Q3W Regimen1.022 RatioGeometric Coefficient of Variation 108
PF-06647020 2.8 mg/kg (Q3W Regimen)Rac for hu6M024 mAb - Q3W Regimen0.9865 RatioGeometric Coefficient of Variation 48
PF-06647020 3.7 mg/kg (Q3W Regimen)Rac for hu6M024 mAb - Q3W RegimenNA Ratio
Secondary

Rac for PF-06380101 - Q2W Regimen

Rac is defined as observed accumulation ratio based on dose normalized AUCtau (AUCtau\[dn\]), where AUCtau is the area under the concentration-time profile from time 0 to time tau (tau equals to 336 hours for the Q2W dosing). Rac= Cycle 3 Day 1 AUCtau(dn) (multiple dose) /Cycle 1 Day 1 AUCtau(dn) (single Dose).

Time frame: pre-dose, end of infusion, 4 hours post-dose on Day 1 of Cycle 1 and Day 1 of Cycle 3 (28 days cycle).

Population: All participants enrolled in Q2W regimen who received at least 1 dose of study treatment and had sufficient information to estimate at least 1 of the PK parameters of interest.

ArmMeasureValue (GEOMETRIC_MEAN)Dispersion
PF-06647020 0.2 mg/kg(Q3W Regimen)Rac for PF-06380101 - Q2W RegimenNA Ratio
PF-06647020 0.5 mg/kg (Q3W Regimen)Rac for PF-06380101 - Q2W Regimen0.9980 RatioGeometric Coefficient of Variation 26
PF-06647020 1.25 mg/kg (Q3W Regimen)Rac for PF-06380101 - Q2W Regimen0.9657 RatioGeometric Coefficient of Variation 25
Secondary

Rac for PF-06380101 - Q3W Regimen

Rac is defined as observed accumulation ratio based on dose normalized AUCtau (AUCtau\[dn\]), where AUCtau is the area under the concentration-time profile from time 0 to time tau (tau equals to 504 hours for the Q3W dosing). Rac=Cycle 4 Day 1 AUCtau(dn) (multiple dose) /Cycle 1 Day 1 AUCtau(dn) (single Dose).

Time frame: pre-dose, 1, 4 hours post-dose on Day 1 of Cycle 1 and Day 1 of Cycle 4 (21 days cycle).

Population: All participants enrolled in Q3W regimen (except DDI sub-study) who received at least 1 dose of study treatment and had sufficient information to estimate at least 1 of the PK parameters of interest.

ArmMeasureValue (GEOMETRIC_MEAN)Dispersion
PF-06647020 0.2 mg/kg(Q3W Regimen)Rac for PF-06380101 - Q3W RegimenNA Ratio
PF-06647020 1.25 mg/kg (Q3W Regimen)Rac for PF-06380101 - Q3W RegimenNA Ratio
PF-06647020 2.1 mg/kg (Q3W Regimen)Rac for PF-06380101 - Q3W Regimen0.5454 RatioGeometric Coefficient of Variation 40
PF-06647020 2.8 mg/kg (Q3W Regimen)Rac for PF-06380101 - Q3W Regimen0.8916 RatioGeometric Coefficient of Variation 41
PF-06647020 3.7 mg/kg (Q3W Regimen)Rac for PF-06380101 - Q3W RegimenNA Ratio
Secondary

Rac for PF-06647020 - Q2W Regimen

Rac is defined as observed accumulation ratio based on dose normalized AUCtau (AUCtau\[dn\]), where AUCtau is the area under the concentration-time profile from time 0 to time tau (tau equals to 336 hours for the Q2W dosing). Rac= Cycle 3 Day 1 AUCtau(dn) (multiple dose) /Cycle 1 Day 1 AUCtau(dn) (single Dose).

Time frame: pre-dose, end of infusion, 4 hours post-dose on Day 1 of Cycle 1 and Day 1 of Cycle 3 (28 days cycle).

Population: All participants enrolled in Q2W regimen who received at least 1 dose of study treatment and had sufficient information to estimate at least 1 of the PK parameters of interest.

ArmMeasureValue (GEOMETRIC_MEAN)Dispersion
PF-06647020 0.2 mg/kg(Q3W Regimen)Rac for PF-06647020 - Q2W RegimenNA Ratio
PF-06647020 0.5 mg/kg (Q3W Regimen)Rac for PF-06647020 - Q2W Regimen1.425 RatioGeometric Coefficient of Variation 35
PF-06647020 1.25 mg/kg (Q3W Regimen)Rac for PF-06647020 - Q2W Regimen1.211 RatioGeometric Coefficient of Variation 18
Secondary

t1/2 for hu6M024 mAb - Q2W Regimen

Terminal half-life (t1/2) is the time measured for the plasma concentration of drug to decrease by one half.

Time frame: pre-dose, end of infusion, 4, 24, 72, 168 hours post-dose, Day 15 (pre-dose, end of infusion) for Cycle 1 and Cycle 3 (28 days cycle).

Population: All participants enrolled in Q2W regimen who received at least 1 dose of study treatment and had sufficient information to estimate at least 1 of the PK parameters of interest.

ArmMeasureGroupValue (MEAN)Dispersion
PF-06647020 0.2 mg/kg(Q3W Regimen)t1/2 for hu6M024 mAb - Q2W RegimenCycle 1, Single DoseNA day
PF-06647020 0.2 mg/kg(Q3W Regimen)t1/2 for hu6M024 mAb - Q2W RegimenCycle 3, Multiple DoseNA day
PF-06647020 0.5 mg/kg (Q3W Regimen)t1/2 for hu6M024 mAb - Q2W RegimenCycle 1, Single Dose3.436 dayStandard Deviation 0.75
PF-06647020 0.5 mg/kg (Q3W Regimen)t1/2 for hu6M024 mAb - Q2W RegimenCycle 3, Multiple Dose4.734 dayStandard Deviation 0.67
PF-06647020 1.25 mg/kg (Q3W Regimen)t1/2 for hu6M024 mAb - Q2W RegimenCycle 1, Single Dose3.645 dayStandard Deviation 0.752
PF-06647020 1.25 mg/kg (Q3W Regimen)t1/2 for hu6M024 mAb - Q2W RegimenCycle 3, Multiple Dose4.124 dayStandard Deviation 1.218
Secondary

t1/2 for hu6M024 mAb - Q3W Regimen

Terminal half-life (t1/2) is the time measured for the plasma concentration of drug to decrease by one half.

Time frame: pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 4 (21 days cycle).

Population: All participants enrolled in Q3W regimen (except DDI sub-study) who received at least 1 dose of study treatment and had sufficient information to estimate at least 1 of the PK parameters of interest.

ArmMeasureGroupValue (MEAN)Dispersion
PF-06647020 0.2 mg/kg(Q3W Regimen)t1/2 for hu6M024 mAb - Q3W RegimenCycle 1, Single DoseNA day
PF-06647020 0.5 mg/kg (Q3W Regimen)t1/2 for hu6M024 mAb - Q3W RegimenCycle 1, Single DoseNA day
PF-06647020 1.25 mg/kg (Q3W Regimen)t1/2 for hu6M024 mAb - Q3W RegimenCycle 4, Multiple DoseNA day
PF-06647020 1.25 mg/kg (Q3W Regimen)t1/2 for hu6M024 mAb - Q3W RegimenCycle 1, Single DoseNA day
PF-06647020 2.1 mg/kg (Q3W Regimen)t1/2 for hu6M024 mAb - Q3W RegimenCycle 4, Multiple Dose5.087 dayStandard Deviation 2.626
PF-06647020 2.1 mg/kg (Q3W Regimen)t1/2 for hu6M024 mAb - Q3W RegimenCycle 1, Single Dose4.505 dayStandard Deviation 0.65
PF-06647020 2.8 mg/kg (Q3W Regimen)t1/2 for hu6M024 mAb - Q3W RegimenCycle 1, Single Dose3.674 dayStandard Deviation 1.512
PF-06647020 2.8 mg/kg (Q3W Regimen)t1/2 for hu6M024 mAb - Q3W RegimenCycle 4, Multiple Dose5.232 dayStandard Deviation 2.259
PF-06647020 3.7 mg/kg (Q3W Regimen)t1/2 for hu6M024 mAb - Q3W RegimenCycle 4, Multiple DoseNA day
PF-06647020 3.7 mg/kg (Q3W Regimen)t1/2 for hu6M024 mAb - Q3W RegimenCycle 1, Single Dose4.386 dayStandard Deviation 0.895
Secondary

t1/2 for PF-06380101 - Q2W Regimen

Terminal half-life (t1/2) is the time measured for the plasma concentration of drug to decrease by one half.

Time frame: pre-dose, end of infusion, 4, 24, 72, 168 hours post-dose, Day 15 (pre-dose, end of infusion) for Cycle 1 and Cycle 3 (28 days cycle).

Population: All participants enrolled in Q2W regimen who received at least 1 dose of study treatment and had sufficient information to estimate at least 1 of the PK parameters of interest.

ArmMeasureGroupValue (MEAN)Dispersion
PF-06647020 0.2 mg/kg(Q3W Regimen)t1/2 for PF-06380101 - Q2W RegimenCycle 1, Single Dose2.507 dayStandard Deviation 0.411
PF-06647020 0.2 mg/kg(Q3W Regimen)t1/2 for PF-06380101 - Q2W RegimenCycle 3, Multiple DoseNA day
PF-06647020 0.5 mg/kg (Q3W Regimen)t1/2 for PF-06380101 - Q2W RegimenCycle 1, Single Dose2.646 dayStandard Deviation 0.453
PF-06647020 0.5 mg/kg (Q3W Regimen)t1/2 for PF-06380101 - Q2W RegimenCycle 3, Multiple Dose2.755 dayStandard Deviation 0.653
PF-06647020 1.25 mg/kg (Q3W Regimen)t1/2 for PF-06380101 - Q2W RegimenCycle 1, Single Dose2.592 dayStandard Deviation 0.331
PF-06647020 1.25 mg/kg (Q3W Regimen)t1/2 for PF-06380101 - Q2W RegimenCycle 3, Multiple Dose3.007 dayStandard Deviation 0.373
Secondary

t1/2 for PF-06380101 - Q3W Regimen

Terminal half-life (t1/2) is the time measured for the plasma concentration of drug to decrease by one half.

Time frame: pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 4 (21 days cycle).

Population: All participants enrolled in Q3W regimen (except DDI sub-study) who received at least 1 dose of study treatment and had sufficient information to estimate at least 1 of the PK parameters of interest.

ArmMeasureGroupValue (MEAN)Dispersion
PF-06647020 0.2 mg/kg(Q3W Regimen)t1/2 for PF-06380101 - Q3W RegimenCycle 4, Multiple DoseNA day
PF-06647020 0.2 mg/kg(Q3W Regimen)t1/2 for PF-06380101 - Q3W RegimenCycle 1, Single DoseNA day
PF-06647020 0.5 mg/kg (Q3W Regimen)t1/2 for PF-06380101 - Q3W RegimenCycle 1, Single DoseNA day
PF-06647020 1.25 mg/kg (Q3W Regimen)t1/2 for PF-06380101 - Q3W RegimenCycle 1, Single DoseNA day
PF-06647020 1.25 mg/kg (Q3W Regimen)t1/2 for PF-06380101 - Q3W RegimenCycle 4, Multiple DoseNA day
PF-06647020 2.1 mg/kg (Q3W Regimen)t1/2 for PF-06380101 - Q3W RegimenCycle 1, Single Dose3.150 dayStandard Deviation 0.426
PF-06647020 2.1 mg/kg (Q3W Regimen)t1/2 for PF-06380101 - Q3W RegimenCycle 4, Multiple Dose2.827 dayStandard Deviation 0.391
PF-06647020 2.8 mg/kg (Q3W Regimen)t1/2 for PF-06380101 - Q3W RegimenCycle 1, Single Dose2.881 dayStandard Deviation 0.604
PF-06647020 2.8 mg/kg (Q3W Regimen)t1/2 for PF-06380101 - Q3W RegimenCycle 4, Multiple Dose2.781 dayStandard Deviation 0.676
PF-06647020 3.7 mg/kg (Q3W Regimen)t1/2 for PF-06380101 - Q3W RegimenCycle 4, Multiple DoseNA day
PF-06647020 3.7 mg/kg (Q3W Regimen)t1/2 for PF-06380101 - Q3W RegimenCycle 1, Single Dose3.210 dayStandard Deviation 0.473
Secondary

t1/2 for PF-06647020 - Q2W Regimen

Terminal half-life (t1/2) is the time measured for the plasma concentration of drug to decrease by one half.

Time frame: pre-dose, end of infusion, 4, 24, 72, 168 hours post-dose, Day 15 (pre-dose, end of infusion) for Cycle 1 and Cycle 3 (28 days cycle).

Population: All participants enrolled in Q2W regimen who received at least 1 dose of study treatment and had sufficient information to estimate at least 1 of the PK parameters of interest.

ArmMeasureGroupValue (MEAN)Dispersion
PF-06647020 0.2 mg/kg(Q3W Regimen)t1/2 for PF-06647020 - Q2W RegimenCycle 1, Single DoseNA day
PF-06647020 0.2 mg/kg(Q3W Regimen)t1/2 for PF-06647020 - Q2W RegimenCycle 3, Multiple DoseNA day
PF-06647020 0.5 mg/kg (Q3W Regimen)t1/2 for PF-06647020 - Q2W RegimenCycle 1, Single Dose2.700 dayStandard Deviation 0.625
PF-06647020 0.5 mg/kg (Q3W Regimen)t1/2 for PF-06647020 - Q2W RegimenCycle 3, Multiple Dose3.633 dayStandard Deviation 0.415
PF-06647020 1.25 mg/kg (Q3W Regimen)t1/2 for PF-06647020 - Q2W RegimenCycle 1, Single Dose2.874 dayStandard Deviation 0.385
PF-06647020 1.25 mg/kg (Q3W Regimen)t1/2 for PF-06647020 - Q2W RegimenCycle 3, Multiple Dose3.600 dayStandard Deviation 0.583
Secondary

Terminal Half-Life (t1/2) for PF-06647020 - Q3W Regimen

Terminal half-life (t1/2) is the time measured for the plasma concentration of drug to decrease by one half.

Time frame: pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 4 (21 days cycle).

Population: All participants enrolled in Q3W regimen (except DDI sub-study) who received at least 1 dose of study treatment and had sufficient information to estimate at least 1 of the PK parameters of interest.

ArmMeasureGroupValue (MEAN)Dispersion
PF-06647020 0.2 mg/kg(Q3W Regimen)Terminal Half-Life (t1/2) for PF-06647020 - Q3W RegimenCycle 4, Multiple DoseNA day
PF-06647020 0.2 mg/kg(Q3W Regimen)Terminal Half-Life (t1/2) for PF-06647020 - Q3W RegimenCycle 1, Single DoseNA day
PF-06647020 0.5 mg/kg (Q3W Regimen)Terminal Half-Life (t1/2) for PF-06647020 - Q3W RegimenCycle 1, Single DoseNA day
PF-06647020 1.25 mg/kg (Q3W Regimen)Terminal Half-Life (t1/2) for PF-06647020 - Q3W RegimenCycle 4, Multiple DoseNA day
PF-06647020 1.25 mg/kg (Q3W Regimen)Terminal Half-Life (t1/2) for PF-06647020 - Q3W RegimenCycle 1, Single DoseNA day
PF-06647020 2.1 mg/kg (Q3W Regimen)Terminal Half-Life (t1/2) for PF-06647020 - Q3W RegimenCycle 4, Multiple Dose4.013 dayStandard Deviation 2.891
PF-06647020 2.1 mg/kg (Q3W Regimen)Terminal Half-Life (t1/2) for PF-06647020 - Q3W RegimenCycle 1, Single Dose3.600 dayStandard Deviation 0.487
PF-06647020 2.8 mg/kg (Q3W Regimen)Terminal Half-Life (t1/2) for PF-06647020 - Q3W RegimenCycle 1, Single Dose3.107 dayStandard Deviation 1.161
PF-06647020 2.8 mg/kg (Q3W Regimen)Terminal Half-Life (t1/2) for PF-06647020 - Q3W RegimenCycle 4, Multiple Dose4.007 dayStandard Deviation 1.496
PF-06647020 3.7 mg/kg (Q3W Regimen)Terminal Half-Life (t1/2) for PF-06647020 - Q3W RegimenCycle 4, Multiple DoseNA day
PF-06647020 3.7 mg/kg (Q3W Regimen)Terminal Half-Life (t1/2) for PF-06647020 - Q3W RegimenCycle 1, Single Dose3.514 dayStandard Deviation 0.696
Secondary

Time for Cmax (Tmax) for PF-06647020 - Q3W Regimen

Tmax is the time for Cmax. Tmax for PF-06647020 was observed directly from data as time of first occurrence.

Time frame: pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 4 (21 days cycle).

Population: All participants enrolled in Q3W regimen (except DDI sub-study) who received at least 1 dose of study treatment and had sufficient information to estimate at least 1 of the PK parameters of interest.

ArmMeasureGroupValue (MEDIAN)
PF-06647020 0.2 mg/kg(Q3W Regimen)Time for Cmax (Tmax) for PF-06647020 - Q3W RegimenCycle 4, Multiple DoseNA hour
PF-06647020 0.2 mg/kg(Q3W Regimen)Time for Cmax (Tmax) for PF-06647020 - Q3W RegimenCycle 1, Single DoseNA hour
PF-06647020 0.5 mg/kg (Q3W Regimen)Time for Cmax (Tmax) for PF-06647020 - Q3W RegimenCycle 1, Single DoseNA hour
PF-06647020 1.25 mg/kg (Q3W Regimen)Time for Cmax (Tmax) for PF-06647020 - Q3W RegimenCycle 1, Single DoseNA hour
PF-06647020 1.25 mg/kg (Q3W Regimen)Time for Cmax (Tmax) for PF-06647020 - Q3W RegimenCycle 4, Multiple DoseNA hour
PF-06647020 2.1 mg/kg (Q3W Regimen)Time for Cmax (Tmax) for PF-06647020 - Q3W RegimenCycle 1, Single Dose2.48 hour
PF-06647020 2.1 mg/kg (Q3W Regimen)Time for Cmax (Tmax) for PF-06647020 - Q3W RegimenCycle 4, Multiple Dose3.05 hour
PF-06647020 2.8 mg/kg (Q3W Regimen)Time for Cmax (Tmax) for PF-06647020 - Q3W RegimenCycle 1, Single Dose1.08 hour
PF-06647020 2.8 mg/kg (Q3W Regimen)Time for Cmax (Tmax) for PF-06647020 - Q3W RegimenCycle 4, Multiple Dose1.65 hour
PF-06647020 3.7 mg/kg (Q3W Regimen)Time for Cmax (Tmax) for PF-06647020 - Q3W RegimenCycle 4, Multiple DoseNA hour
PF-06647020 3.7 mg/kg (Q3W Regimen)Time for Cmax (Tmax) for PF-06647020 - Q3W RegimenCycle 1, Single Dose2.49 hour
Secondary

Time to Progression - Q2W Regimen

Time to progression (TTP) was the time from start date to the date of the first documentation of PD. PD was defined as at least a 20% increase (including an absolute increase of at least 5 mm) in the sum of diameters of target lesions, taking as reference the smallest sum on study and/or unequivocal progression of existing non-target lesions and/or appearance of one or more new lesions.

Time frame: Baseline, every 8 weeks from the start of study treatment until disease progression, death or withdrawal from treatment (approximately 19 months).

Population: Participants enrolled in Q2W regimen with measurable disease (NSCLC, OVCA) who had received at least 1 dose of study medication and had a baseline tumor assessment.

ArmMeasureValue (MEDIAN)
PF-06647020 0.2 mg/kg(Q3W Regimen)Time to Progression - Q2W Regimen2.7 month
PF-06647020 0.5 mg/kg (Q3W Regimen)Time to Progression - Q2W Regimen3.8 month
Secondary

Time to Progression - Q3W Regimen

Time to progression (TTP) was the time from start date to the date of the first documentation of PD. PD was defined as at least a 20% increase (including an absolute increase of at least 5 mm) in the sum of diameters of target lesions, taking as reference the smallest sum on study and/or unequivocal progression of existing non-target lesions and/or appearance of one or more new lesions.

Time frame: Baseline, every 6 weeks from the start of treatment until disease progression, death or withdrawal from treatment (approximately 32 months).

Population: Participants enrolled in Q3W regimen with measurable disease (NSCLC, OVCA, TNBC) who had received at least 1 dose of study medication and had a baseline tumor assessment.

ArmMeasureValue (MEDIAN)
PF-06647020 0.2 mg/kg(Q3W Regimen)Time to Progression - Q3W Regimen2.9 month
PF-06647020 0.5 mg/kg (Q3W Regimen)Time to Progression - Q3W Regimen3.1 month
PF-06647020 1.25 mg/kg (Q3W Regimen)Time to Progression - Q3W Regimen2.2 month
Secondary

Tmax for hu6M024 mAb - Q2W Regimen

Tmax is the time for Cmax. Tmax for hu6M024 mAb was observed directly from data as time of first occurrence.

Time frame: pre-dose, end of infusion, 4, 24, 72, 168 hours post-dose, Day 15 (pre-dose, end of infusion) for Cycle 1 and Cycle 3 (28 days cycle).

Population: All participants enrolled in Q2W regimen who received at least 1 dose of study treatment and had sufficient information to estimate at least 1 of the PK parameters of interest.

ArmMeasureGroupValue (MEDIAN)
PF-06647020 0.2 mg/kg(Q3W Regimen)Tmax for hu6M024 mAb - Q2W RegimenCycle 1, Single Dose3.98 hour
PF-06647020 0.2 mg/kg(Q3W Regimen)Tmax for hu6M024 mAb - Q2W RegimenCycle 3, Multiple DoseNA hour
PF-06647020 0.5 mg/kg (Q3W Regimen)Tmax for hu6M024 mAb - Q2W RegimenCycle 3, Multiple Dose1.05 hour
PF-06647020 0.5 mg/kg (Q3W Regimen)Tmax for hu6M024 mAb - Q2W RegimenCycle 1, Single Dose3.87 hour
PF-06647020 1.25 mg/kg (Q3W Regimen)Tmax for hu6M024 mAb - Q2W RegimenCycle 1, Single Dose1.05 hour
PF-06647020 1.25 mg/kg (Q3W Regimen)Tmax for hu6M024 mAb - Q2W RegimenCycle 3, Multiple Dose2.36 hour
Secondary

Tmax for hu6M024 mAb - Q3W Regimen

Tmax is the time for Cmax. Tmax for hu6M024 mAb was observed directly from data as time of first occurrence.

Time frame: pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 4 (21 days cycle).

Population: All participants enrolled in Q3W regimen (except DDI sub-study) who received at least 1 dose of study treatment and had sufficient information to estimate at least 1 of the PK parameters of interest.

ArmMeasureGroupValue (MEDIAN)
PF-06647020 0.2 mg/kg(Q3W Regimen)Tmax for hu6M024 mAb - Q3W RegimenCycle 4, Multiple DoseNA hour
PF-06647020 0.2 mg/kg(Q3W Regimen)Tmax for hu6M024 mAb - Q3W RegimenCycle 1, Single DoseNA hour
PF-06647020 0.5 mg/kg (Q3W Regimen)Tmax for hu6M024 mAb - Q3W RegimenCycle 1, Single DoseNA hour
PF-06647020 1.25 mg/kg (Q3W Regimen)Tmax for hu6M024 mAb - Q3W RegimenCycle 1, Single DoseNA hour
PF-06647020 1.25 mg/kg (Q3W Regimen)Tmax for hu6M024 mAb - Q3W RegimenCycle 4, Multiple DoseNA hour
PF-06647020 2.1 mg/kg (Q3W Regimen)Tmax for hu6M024 mAb - Q3W RegimenCycle 1, Single Dose4.00 hour
PF-06647020 2.1 mg/kg (Q3W Regimen)Tmax for hu6M024 mAb - Q3W RegimenCycle 4, Multiple Dose3.05 hour
PF-06647020 2.8 mg/kg (Q3W Regimen)Tmax for hu6M024 mAb - Q3W RegimenCycle 1, Single Dose3.70 hour
PF-06647020 2.8 mg/kg (Q3W Regimen)Tmax for hu6M024 mAb - Q3W RegimenCycle 4, Multiple Dose3.90 hour
PF-06647020 3.7 mg/kg (Q3W Regimen)Tmax for hu6M024 mAb - Q3W RegimenCycle 4, Multiple DoseNA hour
PF-06647020 3.7 mg/kg (Q3W Regimen)Tmax for hu6M024 mAb - Q3W RegimenCycle 1, Single Dose2.31 hour
Secondary

Tmax for PF-06380101 - Q2W Regimen

Tmax is the time for Cmax. Tmax for PF-06380101 was observed directly from data as time of first occurrence.

Time frame: pre-dose, end of infusion, 4, 24, 72, 168 hours post-dose, Day 15 (pre-dose, end of infusion) for Cycle 1 and Cycle 3 (28 days cycle).

Population: All participants enrolled in Q2W regimen who received at least 1 dose of study treatment and had sufficient information to estimate at least 1 of the PK parameters of interest.

ArmMeasureGroupValue (MEDIAN)
PF-06647020 0.2 mg/kg(Q3W Regimen)Tmax for PF-06380101 - Q2W RegimenCycle 1, Single Dose3.98 hour
PF-06647020 0.2 mg/kg(Q3W Regimen)Tmax for PF-06380101 - Q2W RegimenCycle 3, Multiple DoseNA hour
PF-06647020 0.5 mg/kg (Q3W Regimen)Tmax for PF-06380101 - Q2W RegimenCycle 1, Single Dose4.05 hour
PF-06647020 0.5 mg/kg (Q3W Regimen)Tmax for PF-06380101 - Q2W RegimenCycle 3, Multiple Dose71.7 hour
PF-06647020 1.25 mg/kg (Q3W Regimen)Tmax for PF-06380101 - Q2W RegimenCycle 1, Single Dose24.7 hour
PF-06647020 1.25 mg/kg (Q3W Regimen)Tmax for PF-06380101 - Q2W RegimenCycle 3, Multiple Dose22.8 hour
Secondary

Tmax for PF-06380101 - Q3W Regimen

Tmax is the time for Cmax. Tmax for PF-06380101 was observed directly from data as time of first occurrence.

Time frame: pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 4 (21 days cycle).

Population: All participants enrolled in Q3W regimen (except DDI sub-study) who received at least 1 dose of study treatment and had sufficient information to estimate at least 1 of the PK parameters of interest.

ArmMeasureGroupValue (MEDIAN)
PF-06647020 0.2 mg/kg(Q3W Regimen)Tmax for PF-06380101 - Q3W RegimenCycle 4, Multiple DoseNA hour
PF-06647020 0.2 mg/kg(Q3W Regimen)Tmax for PF-06380101 - Q3W RegimenCycle 1, Single DoseNA hour
PF-06647020 0.5 mg/kg (Q3W Regimen)Tmax for PF-06380101 - Q3W RegimenCycle 1, Single DoseNA hour
PF-06647020 1.25 mg/kg (Q3W Regimen)Tmax for PF-06380101 - Q3W RegimenCycle 1, Single DoseNA hour
PF-06647020 1.25 mg/kg (Q3W Regimen)Tmax for PF-06380101 - Q3W RegimenCycle 4, Multiple DoseNA hour
PF-06647020 2.1 mg/kg (Q3W Regimen)Tmax for PF-06380101 - Q3W RegimenCycle 4, Multiple Dose23.8 hour
PF-06647020 2.1 mg/kg (Q3W Regimen)Tmax for PF-06380101 - Q3W RegimenCycle 1, Single Dose23.6 hour
PF-06647020 2.8 mg/kg (Q3W Regimen)Tmax for PF-06380101 - Q3W RegimenCycle 1, Single Dose23.9 hour
PF-06647020 2.8 mg/kg (Q3W Regimen)Tmax for PF-06380101 - Q3W RegimenCycle 4, Multiple Dose21.9 hour
PF-06647020 3.7 mg/kg (Q3W Regimen)Tmax for PF-06380101 - Q3W RegimenCycle 4, Multiple DoseNA hour
PF-06647020 3.7 mg/kg (Q3W Regimen)Tmax for PF-06380101 - Q3W RegimenCycle 1, Single Dose23.4 hour
Secondary

Tmax for PF-06647020 - Q2W Regimen

Tmax is the time for Cmax. Tmax for PF-06647020 was observed directly from data as time of first occurrence.

Time frame: pre-dose, end of infusion, 4, 24, 72, 168 hours post-dose, Day 15 (pre-dose, end of infusion) for Cycle 1 and Cycle 3 (28 days cycle).

Population: All participants enrolled in Q2W regimen who received at least 1 dose of study treatment and had sufficient information to estimate at least 1 of the PK parameters of interest.

ArmMeasureGroupValue (MEDIAN)
PF-06647020 0.2 mg/kg(Q3W Regimen)Tmax for PF-06647020 - Q2W RegimenCycle 1, Single Dose3.98 hour
PF-06647020 0.2 mg/kg(Q3W Regimen)Tmax for PF-06647020 - Q2W RegimenCycle 3, Multiple DoseNA hour
PF-06647020 0.5 mg/kg (Q3W Regimen)Tmax for PF-06647020 - Q2W RegimenCycle 1, Single Dose2.45 hour
PF-06647020 0.5 mg/kg (Q3W Regimen)Tmax for PF-06647020 - Q2W RegimenCycle 3, Multiple Dose1.07 hour
PF-06647020 1.25 mg/kg (Q3W Regimen)Tmax for PF-06647020 - Q2W RegimenCycle 1, Single Dose1.05 hour
PF-06647020 1.25 mg/kg (Q3W Regimen)Tmax for PF-06647020 - Q2W RegimenCycle 3, Multiple Dose2.36 hour
Secondary

Volume of Distribution at Steady State (Vss) for PF-06647020 - Q3W Regimen

Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady-state.

Time frame: pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 4 (21 days cycle).

Population: All participants enrolled in Q3W regimen (except DDI sub-study) who received at least 1 dose of study treatment and had sufficient information to estimate at least 1 of the PK parameters of interest.

ArmMeasureGroupValue (GEOMETRIC_MEAN)Dispersion
PF-06647020 0.2 mg/kg(Q3W Regimen)Volume of Distribution at Steady State (Vss) for PF-06647020 - Q3W RegimenCycle 4, Multiple DoseNA Liter (L)
PF-06647020 0.2 mg/kg(Q3W Regimen)Volume of Distribution at Steady State (Vss) for PF-06647020 - Q3W RegimenCycle 1, Single DoseNA Liter (L)
PF-06647020 0.5 mg/kg (Q3W Regimen)Volume of Distribution at Steady State (Vss) for PF-06647020 - Q3W RegimenCycle 1, Single DoseNA Liter (L)
PF-06647020 1.25 mg/kg (Q3W Regimen)Volume of Distribution at Steady State (Vss) for PF-06647020 - Q3W RegimenCycle 1, Single DoseNA Liter (L)
PF-06647020 1.25 mg/kg (Q3W Regimen)Volume of Distribution at Steady State (Vss) for PF-06647020 - Q3W RegimenCycle 4, Multiple DoseNA Liter (L)
PF-06647020 2.1 mg/kg (Q3W Regimen)Volume of Distribution at Steady State (Vss) for PF-06647020 - Q3W RegimenCycle 1, Single Dose3.498 Liter (L)Geometric Coefficient of Variation 26
PF-06647020 2.1 mg/kg (Q3W Regimen)Volume of Distribution at Steady State (Vss) for PF-06647020 - Q3W RegimenCycle 4, Multiple Dose3.230 Liter (L)Geometric Coefficient of Variation 46
PF-06647020 2.8 mg/kg (Q3W Regimen)Volume of Distribution at Steady State (Vss) for PF-06647020 - Q3W RegimenCycle 1, Single Dose3.199 Liter (L)Geometric Coefficient of Variation 40
PF-06647020 2.8 mg/kg (Q3W Regimen)Volume of Distribution at Steady State (Vss) for PF-06647020 - Q3W RegimenCycle 4, Multiple Dose2.808 Liter (L)Geometric Coefficient of Variation 47
PF-06647020 3.7 mg/kg (Q3W Regimen)Volume of Distribution at Steady State (Vss) for PF-06647020 - Q3W RegimenCycle 4, Multiple DoseNA Liter (L)
PF-06647020 3.7 mg/kg (Q3W Regimen)Volume of Distribution at Steady State (Vss) for PF-06647020 - Q3W RegimenCycle 1, Single Dose3.947 Liter (L)Geometric Coefficient of Variation 52
Secondary

Vss for PF-06647020 - Q2W Regimen

Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady-state.

Time frame: pre-dose, end of infusion, 4, 24, 72, 168 hours post-dose, Day 15 (pre-dose, end of infusion) for Cycle 1 and Cycle 3 (28 days cycle).

Population: All participants enrolled in Q2W regimen who received at least 1 dose of study treatment and had sufficient information to estimate at least 1 of the PK parameters of interest.

ArmMeasureGroupValue (GEOMETRIC_MEAN)Dispersion
PF-06647020 0.2 mg/kg(Q3W Regimen)Vss for PF-06647020 - Q2W RegimenCycle 1, Single DoseNA Liter
PF-06647020 0.2 mg/kg(Q3W Regimen)Vss for PF-06647020 - Q2W RegimenCycle 3, Multiple DoseNA Liter
PF-06647020 0.5 mg/kg (Q3W Regimen)Vss for PF-06647020 - Q2W RegimenCycle 1, Single Dose2.566 LiterGeometric Coefficient of Variation 44
PF-06647020 0.5 mg/kg (Q3W Regimen)Vss for PF-06647020 - Q2W RegimenCycle 3, Multiple Dose2.349 LiterGeometric Coefficient of Variation 24
PF-06647020 1.25 mg/kg (Q3W Regimen)Vss for PF-06647020 - Q2W RegimenCycle 1, Single Dose2.953 LiterGeometric Coefficient of Variation 36
PF-06647020 1.25 mg/kg (Q3W Regimen)Vss for PF-06647020 - Q2W RegimenCycle 3, Multiple Dose3.106 LiterGeometric Coefficient of Variation 32

Source: ClinicalTrials.gov · Data processed: Feb 24, 2026