Advanced Solid Tumors, Cancer, Carcinoma, Malignancy, Neoplasms
Conditions
Keywords
Phase 1, Tumors, CVX-060
Brief summary
The purpose of this study is to determine the safety and tolerability of CVX-060 in patients with advanced solid tumors.
Interventions
BIOLOGICALCVX-060
Weekly, intravenous dose
Sponsors
Pfizer
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Confirmed advanced solid tumors unresponsive to currently available therapies or for which there is no standard therapy. * Adequate coagulation, liver, and renal function. * Candidate for DCE-MRI evaluations. * ECOG (Eastern Cooperative Oncology Group) performance status of 0 or 1.
Exclusion criteria
* Evidence of significant bleeding problems. * History of certain gastrointestinal problems including fistula and abscess. * Chronic, uncontrolled hypertension. * Patients with any history of primary or metastatic tumor involvement of the brain or with tumors that encase great vessels.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs) | Baseline (Day 0) up to 30 days after last dose of study medication | Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. 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 are events between first dose of study drug and up to 30 days after last dose that were absent before treatment or that worsened relative to pretreatment state. Relatedness to CVX-060 was assessed by the investigator (Yes/No). Participants with multiple occurrences of an AE within a category were counted once within the category. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serum Decay Half-Life (t1/2) | 0 hour (pre-dose) on Day 0 up to Day 7 of cycle 1 (28 days cycle) | Serum decay half-life is the time measured for the serum concentration to decrease by one half. |
| Area Under the Curve From Time Zero to 168 Hours [AUC (0-168)] | 0 hour (pre-dose) on Day 0 up to Day 7 of cycle 1 (28 days cycle) | AUC (0-168)= Area under the serum concentration versus time curve from time zero (pre-dose) to 168 hours after dosing (Day 7). |
| Apparent Volume of Distribution (Vss) | 0 hour (pre-dose) on Day 0 up to Day 7 of cycle 1 (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 plasma concentration of a drug. Apparent volume of distribution after intravenous infusion dose (Vss) is influenced by the fraction absorbed. |
| Apparent Clearance (CL) | 0 hour (pre-dose) on Day 0 up to Day 7 of cycle 1 (28 days cycle) | Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood (rate at which a drug is metabolized or eliminated by normal biological processes). Clearance obtained after intravenous infusion dose (apparent clearance) is influenced by the fraction of the dose absorbed. |
| Maximum Observed Serum Concentration (Cmax) | 0 hour (pre-dose) on Day 0 up to Day 7 of cycle 1 (28 days cycle) | — |
| Recommended Phase 2 Dose (RP2D): Stage 1 | Baseline (Day 0) up to 42 days after the last dose of study medication | RP2D was determined as the highest dose where none out of 3 (0/3) or less than or equal to 1 out of 6 (\<=1/6) participants experienced a dose limiting toxicity (DLT) or was determined based on the safety, pharmacokinetic, and pharmacodynamic findings. DLT was first course AE defined based on National Cancer Institute common toxicity criteria for adverse events version 3 (NCI-CTCAE Version 3) as any hematologic or non-hematologic toxicity greater than or equal to (\>=) Grade 3. |
| Number of Participants With Anti-CVX-060 Antibodies | Baseline (Day 0) up to 42 days after last dose | — |
| Number of Samples From Participants With Anti-CVX-060 Antibodies | Baseline (Day 0) up to 42 days after last dose | — |
| Number of Participants With Best Overall Response (BOR) | Day 0 (predose), assessed every 8 weeks (2 cycles) until disease progression, unacceptable toxicity, or withdrawal for other reasons (up to Week 133) | BOR: best response recorded from treatment start until disease progression/recurrence based on Response Evaluation Criteria in Solid Tumors (RECIST). Complete Response (CR): disappearance of all lesions. Partial Response (PR): \>=30% decrease in sum of longest diameters (SLDs) of target lesions taking as reference baseline SLDs, associated to non-progressive disease (non-PD) response for non-target (NT) lesions. PD: \>=20% increase in SLDs of target lesions taking as reference smallest SLDs since treatment start, or appearance of \>=1 new lesion, or unequivocal progression in NT lesions. Stable disease (SD): neither shrinkage for CR/PR nor increase for PD taking as reference smallest SLDs since treatment start. CR and PR had to be confirmed on a follow up imaging assessment \>=4 weeks after initial objective documentation of response. SD criteria should be met at least once after start of treatment in a minimum interval of 8 weeks. Participants with \>=3 treatments cycles were reported. |
| Time to Reach Maximum Observed Serum Concentration (Tmax) | 0 hour (pre-dose) on Day 0 up to Day 7 of cycle 1 (28 days cycle) | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| CVX-060 (Stage 1 and 2) CVX-060 0.3, 1, 3, 6, 12, 15 mg/kg of body weight intravenous infusion in Stage 1 and CVX-060 15 mg/kg of body weight intravenous infusion in Stage 2, administered once-weekly in a 4-week cycle. | 34 |
| Total | 34 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 |
|---|---|---|---|---|---|---|---|---|
| Stage 1: Dose Escalation | Adverse Event | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
| Stage 1: Dose Escalation | Death | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
| Stage 1: Dose Escalation | Investigator declined participation | 0 | 0 | 2 | 2 | 0 | 0 | 0 |
| Stage 1: Dose Escalation | Progressive Disease | 2 | 3 | 0 | 4 | 3 | 3 | 0 |
| Stage 2: Expanded Cohort | Investigator declined participation | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
| Stage 2: Expanded Cohort | Lost to Follow-up | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
| Stage 2: Expanded Cohort | Progressive Disease | 0 | 0 | 0 | 0 | 0 | 0 | 11 |
Baseline characteristics
| Characteristic | CVX-060 (Stage 1 and 2) |
|---|---|
| Age, Continuous | 59.8 years STANDARD_DEVIATION 14.62 |
| Sex: Female, Male Female | 21 Participants |
| Sex: Female, Male Male | 13 Participants |
Adverse events
| Event type | EG000 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 |
|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 3 / 3 | 3 / 3 | 3 / 3 | 6 / 6 | 3 / 3 | 3 / 3 | 12 / 13 |
| serious Total, serious adverse events | 1 / 3 | 0 / 3 | 2 / 3 | 3 / 6 | 0 / 3 | 0 / 3 | 3 / 13 |
Outcome results
Primary
Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs)
Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. 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 are events between first dose of study drug and up to 30 days after last dose that were absent before treatment or that worsened relative to pretreatment state. Relatedness to CVX-060 was assessed by the investigator (Yes/No). Participants with multiple occurrences of an AE within a category were counted once within the category.
Time frame: Baseline (Day 0) up to 30 days after last dose of study medication
Population: Safety population included all enrolled participants in the study who received any study medication.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CVX-060 0.3 mg/kg (Stage 1) | Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs) | 2 participants |
| CVX-060 1 mg/kg (Stage 1) | Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs) | 3 participants |
| CVX-060 3 mg/kg (Stage 1) | Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs) | 1 participants |
| CVX-060 6 mg/kg (Stage 1) | Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs) | 2 participants |
| CVX-060 12 mg/kg (Stage 1) | Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs) | 2 participants |
| CVX-060 15 mg/kg (Stage 1) | Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs) | 1 participants |
| CVX-060 15 mg/kg (Stage 2) | Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs) | 2 participants |
Secondary
Apparent Clearance (CL)
Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood (rate at which a drug is metabolized or eliminated by normal biological processes). Clearance obtained after intravenous infusion dose (apparent clearance) is influenced by the fraction of the dose absorbed.
Time frame: 0 hour (pre-dose) on Day 0 up to Day 7 of cycle 1 (28 days cycle)
Population: PK analysis set included all participants who received at least 1 dose of CVX-060 and had PK data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| CVX-060 0.3 mg/kg (Stage 1) | Apparent Clearance (CL) | 0.1684 (mL/hr)/kg | Standard Deviation 0.02788 |
| CVX-060 1 mg/kg (Stage 1) | Apparent Clearance (CL) | 0.4399 (mL/hr)/kg | Standard Deviation 0.30607 |
| CVX-060 3 mg/kg (Stage 1) | Apparent Clearance (CL) | 0.4225 (mL/hr)/kg | Standard Deviation 0.12469 |
| CVX-060 6 mg/kg (Stage 1) | Apparent Clearance (CL) | 0.3222 (mL/hr)/kg | Standard Deviation 0.10413 |
| CVX-060 12 mg/kg (Stage 1) | Apparent Clearance (CL) | 0.3078 (mL/hr)/kg | Standard Deviation 0.05 |
| CVX-060 15 mg/kg (Stage 1) | Apparent Clearance (CL) | 0.3483 (mL/hr)/kg | Standard Deviation 0.16529 |
Secondary
Apparent Volume of Distribution (Vss)
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 plasma concentration of a drug. Apparent volume of distribution after intravenous infusion dose (Vss) is influenced by the fraction absorbed.
Time frame: 0 hour (pre-dose) on Day 0 up to Day 7 of cycle 1 (28 days cycle)
Population: PK analysis set included all participants who received at least 1 dose of CVX-060 and had PK data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| CVX-060 0.3 mg/kg (Stage 1) | Apparent Volume of Distribution (Vss) | 32.34 milliliter per kilogram (mL/kg) | Standard Deviation 7.8869 |
| CVX-060 1 mg/kg (Stage 1) | Apparent Volume of Distribution (Vss) | 54.15 milliliter per kilogram (mL/kg) | Standard Deviation 9.4875 |
| CVX-060 3 mg/kg (Stage 1) | Apparent Volume of Distribution (Vss) | 50.70 milliliter per kilogram (mL/kg) | Standard Deviation 7.99 |
| CVX-060 6 mg/kg (Stage 1) | Apparent Volume of Distribution (Vss) | 51.07 milliliter per kilogram (mL/kg) | Standard Deviation 12.451 |
| CVX-060 12 mg/kg (Stage 1) | Apparent Volume of Distribution (Vss) | 54.58 milliliter per kilogram (mL/kg) | Standard Deviation 5.1033 |
| CVX-060 15 mg/kg (Stage 1) | Apparent Volume of Distribution (Vss) | 59.67 milliliter per kilogram (mL/kg) | Standard Deviation 12.711 |
Secondary
Area Under the Curve From Time Zero to 168 Hours [AUC (0-168)]
AUC (0-168)= Area under the serum concentration versus time curve from time zero (pre-dose) to 168 hours after dosing (Day 7).
Time frame: 0 hour (pre-dose) on Day 0 up to Day 7 of cycle 1 (28 days cycle)
Population: PK analysis set included all participants who received at least 1 dose of CVX-060 and had PK data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| CVX-060 0.3 mg/kg (Stage 1) | Area Under the Curve From Time Zero to 168 Hours [AUC (0-168)] | 1030000 nanogram*hour per milliliter (ng*hr/mL) | Standard Deviation 155260 |
| CVX-060 1 mg/kg (Stage 1) | Area Under the Curve From Time Zero to 168 Hours [AUC (0-168)] | 1644000 nanogram*hour per milliliter (ng*hr/mL) | Standard Deviation 606660 |
| CVX-060 3 mg/kg (Stage 1) | Area Under the Curve From Time Zero to 168 Hours [AUC (0-168)] | 5259000 nanogram*hour per milliliter (ng*hr/mL) | Standard Deviation 1127200 |
| CVX-060 6 mg/kg (Stage 1) | Area Under the Curve From Time Zero to 168 Hours [AUC (0-168)] | 11990000 nanogram*hour per milliliter (ng*hr/mL) | Standard Deviation 3437600 |
| CVX-060 12 mg/kg (Stage 1) | Area Under the Curve From Time Zero to 168 Hours [AUC (0-168)] | 23700000 nanogram*hour per milliliter (ng*hr/mL) | Standard Deviation 2254600 |
| CVX-060 15 mg/kg (Stage 1) | Area Under the Curve From Time Zero to 168 Hours [AUC (0-168)] | 26410000 nanogram*hour per milliliter (ng*hr/mL) | Standard Deviation 6658800 |
Secondary
Maximum Observed Serum Concentration (Cmax)
Time frame: 0 hour (pre-dose) on Day 0 up to Day 7 of cycle 1 (28 days cycle)
Population: Pharmacokinetic (PK) analysis set included all participants who received at least 1 dose of CVX-060 and had PK data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| CVX-060 0.3 mg/kg (Stage 1) | Maximum Observed Serum Concentration (Cmax) | 10550 nanogram per milliliter (ng/mL) | Standard Deviation 1358.4 |
| CVX-060 1 mg/kg (Stage 1) | Maximum Observed Serum Concentration (Cmax) | 22660 nanogram per milliliter (ng/mL) | Standard Deviation 5230.7 |
| CVX-060 3 mg/kg (Stage 1) | Maximum Observed Serum Concentration (Cmax) | 68280 nanogram per milliliter (ng/mL) | Standard Deviation 11149 |
| CVX-060 6 mg/kg (Stage 1) | Maximum Observed Serum Concentration (Cmax) | 140300 nanogram per milliliter (ng/mL) | Standard Deviation 28247 |
| CVX-060 12 mg/kg (Stage 1) | Maximum Observed Serum Concentration (Cmax) | 249600 nanogram per milliliter (ng/mL) | Standard Deviation 58381 |
| CVX-060 15 mg/kg (Stage 1) | Maximum Observed Serum Concentration (Cmax) | 318600 nanogram per milliliter (ng/mL) | Standard Deviation 66472 |
Secondary
Number of Participants With Anti-CVX-060 Antibodies
Time frame: Baseline (Day 0) up to 42 days after last dose
Population: Anti-drug antibodies (ADA) analysis set included all participants who received at least 1 dose of CVX-060 and had PK data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CVX-060 0.3 mg/kg (Stage 1) | Number of Participants With Anti-CVX-060 Antibodies | 20 participants |
Secondary
Number of Participants With Best Overall Response (BOR)
BOR: best response recorded from treatment start until disease progression/recurrence based on Response Evaluation Criteria in Solid Tumors (RECIST). Complete Response (CR): disappearance of all lesions. Partial Response (PR): \>=30% decrease in sum of longest diameters (SLDs) of target lesions taking as reference baseline SLDs, associated to non-progressive disease (non-PD) response for non-target (NT) lesions. PD: \>=20% increase in SLDs of target lesions taking as reference smallest SLDs since treatment start, or appearance of \>=1 new lesion, or unequivocal progression in NT lesions. Stable disease (SD): neither shrinkage for CR/PR nor increase for PD taking as reference smallest SLDs since treatment start. CR and PR had to be confirmed on a follow up imaging assessment \>=4 weeks after initial objective documentation of response. SD criteria should be met at least once after start of treatment in a minimum interval of 8 weeks. Participants with \>=3 treatments cycles were reported.
Time frame: Day 0 (predose), assessed every 8 weeks (2 cycles) until disease progression, unacceptable toxicity, or withdrawal for other reasons (up to Week 133)
Population: Safety population included all enrolled participants in the study who received any study medication.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CVX-060 0.3 mg/kg (Stage 1) | Number of Participants With Best Overall Response (BOR) | Partial Response | 0 participants |
| CVX-060 0.3 mg/kg (Stage 1) | Number of Participants With Best Overall Response (BOR) | Progressive Disease | 1 participants |
| CVX-060 0.3 mg/kg (Stage 1) | Number of Participants With Best Overall Response (BOR) | Stable Disease | 2 participants |
| CVX-060 0.3 mg/kg (Stage 1) | Number of Participants With Best Overall Response (BOR) | Complete Response | 0 participants |
| CVX-060 1 mg/kg (Stage 1) | Number of Participants With Best Overall Response (BOR) | Complete Response | 0 participants |
| CVX-060 1 mg/kg (Stage 1) | Number of Participants With Best Overall Response (BOR) | Progressive Disease | 1 participants |
| CVX-060 1 mg/kg (Stage 1) | Number of Participants With Best Overall Response (BOR) | Stable Disease | 2 participants |
| CVX-060 1 mg/kg (Stage 1) | Number of Participants With Best Overall Response (BOR) | Partial Response | 0 participants |
| CVX-060 3 mg/kg (Stage 1) | Number of Participants With Best Overall Response (BOR) | Progressive Disease | 0 participants |
| CVX-060 3 mg/kg (Stage 1) | Number of Participants With Best Overall Response (BOR) | Partial Response | 0 participants |
| CVX-060 3 mg/kg (Stage 1) | Number of Participants With Best Overall Response (BOR) | Complete Response | 0 participants |
| CVX-060 3 mg/kg (Stage 1) | Number of Participants With Best Overall Response (BOR) | Stable Disease | 1 participants |
| CVX-060 6 mg/kg (Stage 1) | Number of Participants With Best Overall Response (BOR) | Progressive Disease | 0 participants |
| CVX-060 6 mg/kg (Stage 1) | Number of Participants With Best Overall Response (BOR) | Partial Response | 0 participants |
| CVX-060 6 mg/kg (Stage 1) | Number of Participants With Best Overall Response (BOR) | Stable Disease | 3 participants |
| CVX-060 6 mg/kg (Stage 1) | Number of Participants With Best Overall Response (BOR) | Complete Response | 0 participants |
| CVX-060 12 mg/kg (Stage 1) | Number of Participants With Best Overall Response (BOR) | Complete Response | 0 participants |
| CVX-060 12 mg/kg (Stage 1) | Number of Participants With Best Overall Response (BOR) | Progressive Disease | 2 participants |
| CVX-060 12 mg/kg (Stage 1) | Number of Participants With Best Overall Response (BOR) | Stable Disease | 1 participants |
| CVX-060 12 mg/kg (Stage 1) | Number of Participants With Best Overall Response (BOR) | Partial Response | 0 participants |
| CVX-060 15 mg/kg (Stage 1) | Number of Participants With Best Overall Response (BOR) | Stable Disease | 1 participants |
| CVX-060 15 mg/kg (Stage 1) | Number of Participants With Best Overall Response (BOR) | Progressive Disease | 2 participants |
| CVX-060 15 mg/kg (Stage 1) | Number of Participants With Best Overall Response (BOR) | Complete Response | 0 participants |
| CVX-060 15 mg/kg (Stage 1) | Number of Participants With Best Overall Response (BOR) | Partial Response | 0 participants |
| CVX-060 15 mg/kg (Stage 2) | Number of Participants With Best Overall Response (BOR) | Progressive Disease | 3 participants |
| CVX-060 15 mg/kg (Stage 2) | Number of Participants With Best Overall Response (BOR) | Complete Response | 0 participants |
| CVX-060 15 mg/kg (Stage 2) | Number of Participants With Best Overall Response (BOR) | Partial Response | 0 participants |
| CVX-060 15 mg/kg (Stage 2) | Number of Participants With Best Overall Response (BOR) | Stable Disease | 6 participants |
Secondary
Number of Samples From Participants With Anti-CVX-060 Antibodies
Time frame: Baseline (Day 0) up to 42 days after last dose
Population: Anti-drug antibodies (ADA) analysis set included all participants who received at least 1 dose of CVX-060 and had PK data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CVX-060 0.3 mg/kg (Stage 1) | Number of Samples From Participants With Anti-CVX-060 Antibodies | 45 samples |
Secondary
Recommended Phase 2 Dose (RP2D): Stage 1
RP2D was determined as the highest dose where none out of 3 (0/3) or less than or equal to 1 out of 6 (\<=1/6) participants experienced a dose limiting toxicity (DLT) or was determined based on the safety, pharmacokinetic, and pharmacodynamic findings. DLT was first course AE defined based on National Cancer Institute common toxicity criteria for adverse events version 3 (NCI-CTCAE Version 3) as any hematologic or non-hematologic toxicity greater than or equal to (\>=) Grade 3.
Time frame: Baseline (Day 0) up to 42 days after the last dose of study medication
Population: Safety population included all enrolled participants in the study who received any study medication.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CVX-060 0.3 mg/kg (Stage 1) | Recommended Phase 2 Dose (RP2D): Stage 1 | 15 (mg/kg)/week |
Secondary
Serum Decay Half-Life (t1/2)
Serum decay half-life is the time measured for the serum concentration to decrease by one half.
Time frame: 0 hour (pre-dose) on Day 0 up to Day 7 of cycle 1 (28 days cycle)
Population: PK analysis set included all participants who received at least 1 dose of CVX-060 and had PK data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CVX-060 0.3 mg/kg (Stage 1) | Serum Decay Half-Life (t1/2) | 138.1 hours | Standard Deviation 36.927 |
| CVX-060 1 mg/kg (Stage 1) | Serum Decay Half-Life (t1/2) | 92.23 hours | Standard Deviation 36.229 |
| CVX-060 3 mg/kg (Stage 1) | Serum Decay Half-Life (t1/2) | 86.83 hours | Standard Deviation 25.002 |
| CVX-060 6 mg/kg (Stage 1) | Serum Decay Half-Life (t1/2) | 115.2 hours | Standard Deviation 32.536 |
| CVX-060 12 mg/kg (Stage 1) | Serum Decay Half-Life (t1/2) | 124.7 hours | Standard Deviation 19.009 |
| CVX-060 15 mg/kg (Stage 1) | Serum Decay Half-Life (t1/2) | 129.9 hours | Standard Deviation 51.813 |
Secondary
Time to Reach Maximum Observed Serum Concentration (Tmax)
Time frame: 0 hour (pre-dose) on Day 0 up to Day 7 of cycle 1 (28 days cycle)
Population: PK analysis set included all participants who received at least 1 dose of CVX-060 and had PK data.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| CVX-060 0.3 mg/kg (Stage 1) | Time to Reach Maximum Observed Serum Concentration (Tmax) | 2.35 hours |
| CVX-060 1 mg/kg (Stage 1) | Time to Reach Maximum Observed Serum Concentration (Tmax) | 1.50 hours |
| CVX-060 3 mg/kg (Stage 1) | Time to Reach Maximum Observed Serum Concentration (Tmax) | 2.62 hours |
| CVX-060 6 mg/kg (Stage 1) | Time to Reach Maximum Observed Serum Concentration (Tmax) | 2.54 hours |
| CVX-060 12 mg/kg (Stage 1) | Time to Reach Maximum Observed Serum Concentration (Tmax) | 2.42 hours |
| CVX-060 15 mg/kg (Stage 1) | Time to Reach Maximum Observed Serum Concentration (Tmax) | 2.50 hours |