Advanced Malignancies, Metastatic Cancer
Conditions
Keywords
Solid tumor, adenocarcinoma of the endometrium, ovarian cancer, renal cell carcinoma, melanoma, non-small cell lung cancer, OX40, immunoglobulin G monoclonal antibody
Brief summary
The purpose of this study is to determine the safety and tolerability and assess preliminary efficacy of INCAGN01949 in subjects with advanced or metastatic solid tumors.
Interventions
DRUGINCAGN01949
Initial cohort dose of INCAGN01949 monotherapy at the protocol-defined starting dose, with subsequent cohort escalations based on protocol-specific criteria. The recommended dose will be taken forward into expansion cohorts.
Sponsors
Incyte Biosciences International Sàrl
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Locally advanced or metastatic disease; locally advanced disease must not be amenable to resection with curative intent. * Subjects who have disease progression after treatment with available therapies that are known to confer clinical benefit, or who are intolerant to treatment, or who refuse standard treatment. There is no limit to the number of prior treatment regimens. * Part 1: Subjects with advanced or metastatic solid tumors. * Part 2: Subjects with advanced or metastatic adenocarcinoma of the endometrium, ovarian cancer, renal cell carcinoma, melanoma, and non-small cell lung cancer. * Presence of measureable disease based on RECIST v1.1. * Eastern Cooperative Oncology Group performance status 0 or 1.
Exclusion criteria
* Laboratory and medical history parameters not within the protocol-defined range. * Receipt of anticancer medications or investigational drugs within the protocol-defined intervals before the first administration of study drug. * Has not recovered to ≤ Grade 1 from toxic effects of prior therapy (including prior immunotherapy) and/or complications from prior surgical intervention before starting therapy. * Receipt of a live vaccine within 30 days of planned start of study drug. * Active autoimmune disease that required systemic treatment in the past.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Treatment-related Adverse Events | From screening through 60 days after end of treatment, up to 11 months | Adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug/treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maximum Observed Concentration (Cmax) of INCAGN01949 in Plasma | Pre-infusion for cycles 1,2,3,4,5,6 and 7, 10-minutes, 4 hrs, 24 hrs post-infusion, Day 8 for cycles 1 & 6 | To evaluate the Cmax of INCAGN01949 in subjects with advanced or metastatic solid tumors. |
| Area Under the Single-dose Concentration-time Curve (AUC0-t) of INCAGN01949 | Pre-infusion for cycles 1,2,3,4,5,6 and 7, 10-minutes, 4 hrs, 24 hrs post-infusion, Day 8 for cycles 1 & 6 | To evaluate the AUC0-t of INCAGN01949 in subjects with advanced or metastatic solid tumors |
| Objective Response Rate Per RECIST and Modified RECIST | Baseline and every 8 weeks,up to 11 months | ORR was defined as the percentage of participants who had a confirmed complete response (CR) or partial response (PR) per RECIST v1.1 and mRECIST v1.1. by investigator determination. |
| Duration of Disease Control Per RECIST and Modified RECIST | Baseline and every 8 weeks, up to 11 months | ORR was defined as the percentage of participants who had a confirmed complete response (CR) or partial response (PR) per RECIST v1.1 and mRECIST v1.1. by investigator determination. |
| Progression-free Survival Per RECIST and Modified RECIST | Baseline and every 8 weeks, up to 11 months | ORR was defined as the percentage of participants who had a confirmed complete response (CR) or partial response (PR) per RECIST v1.1 and mRECIST v1.1. by investigator determination. |
| Time to Maximum Concentration of INCAGN01949 in Plasma | Pre-infusion for cycles 1,2,3,4,5,6 and 7, 10-minutes, 4 hrs, 24 hrs post-infusion, Day 8 for cycles 1 & 6 | To evaluate the Tmax of INCAGN01949 in subjects with advanced or metastatic solid tumors. |
| Summary of Trough Concentrations(Cmin) of INCAGN01949 | Pre-infusion for cycles 1,2,3,4,5,6 and 7, 10-minutes, 4 hrs, 24 hrs post-infusion, Day 8 for cycles 1 & 6 | To evaluate the Cmin of INCAGN01949 in subjects with advanced or metastatic solid tumors. Cmin is the minimum observed concentration of INCAGN1949 |
| Duration of Response Per RECIST and Modified RECIST | Baseline and every 8 weeks, up to 11 months | ORR was defined as the percentage of participants who had a confirmed complete response (CR) or partial response (PR) per RECIST v1.1 and mRECIST v1.1. by investigator determination. |
Countries
Spain, Switzerland, United Kingdom, United States
Participant flow
Recruitment details
The study was conducted at 4 different sites in US, 1 site in Switzerland,1 site in Spain and 2 sites in the United Kingdom.
Pre-assignment details
A total of 129 participants were screened for this study, of which 42 participants were screen failures and 87 participants were randomized to treatment.
Participants by arm
| Arm | Count |
|---|---|
| PART 1 Dose 1 (7 mg) INCAGN01949 7mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors | 4 |
| PART 1 Dose 2 (20 mg) INCAGN01949 20mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors | 4 |
| PART 1 Dose 3 (70 mg) INCAGN01949 70mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors | 22 |
| PART 1 Dose 4 (200 mg) INCAGN01949 200mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors | 18 |
| PART 1 Dose 5 (350 mg) INCAGN01949 350mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors | 23 |
| PART 1 Dose 6 (700 mg) INCAGN01949 700mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors | 12 |
| PART 1 Dose 7 (1400 mg) INCAGN01949 1400mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors | 4 |
| Total | 87 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 |
|---|---|---|---|---|---|---|---|---|
| Overall Study | Death | 1 | 0 | 2 | 4 | 2 | 3 | 0 |
| Overall Study | Lost to Follow-up | 0 | 0 | 3 | 0 | 1 | 1 | 0 |
| Overall Study | Other | 1 | 2 | 4 | 1 | 3 | 0 | 1 |
| Overall Study | Physician Decision | 0 | 0 | 0 | 1 | 1 | 0 | 2 |
| Overall Study | Withdrawal by Subject | 2 | 2 | 8 | 10 | 12 | 3 | 0 |
Baseline characteristics
| Characteristic | PART 1 Dose 1 (7 mg) | PART 1 Dose 2 (20 mg) | PART 1 Dose 3 (70 mg) | PART 1 Dose 4 (200 mg) | PART 1 Dose 5 (350 mg) | PART 1 Dose 6 (700 mg) | PART 1 Dose 7 (1400 mg) | Total |
|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 54.3 years STANDARD_DEVIATION 16.24 | 63.8 years STANDARD_DEVIATION 12.63 | 56.8 years STANDARD_DEVIATION 14.27 | 58.9 years STANDARD_DEVIATION 12.78 | 58.1 years STANDARD_DEVIATION 12.44 | 61.3 years STANDARD_DEVIATION 9.93 | 52.8 years STANDARD_DEVIATION 24.5 | 58.2 years STANDARD_DEVIATION 13.24 |
| Race/Ethnicity, Customized Asian | 0 participants | 1 participants | 2 participants | 0 participants | 0 participants | 1 participants | 0 participants | 4 participants |
| Race/Ethnicity, Customized Black/African American | 0 participants | 0 participants | 0 participants | 0 participants | 0 participants | 2 participants | 0 participants | 2 participants |
| Race/Ethnicity, Customized Hispanic or Latino | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 1 Participants | 1 Participants | 4 Participants |
| Race/Ethnicity, Customized Not Hispanic or Latino | 4 Participants | 4 Participants | 19 Participants | 16 Participants | 22 Participants | 11 Participants | 2 Participants | 78 Participants |
| Race/Ethnicity, Customized Not Reported | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 1 Participants | 0 Participants | 1 Participants | 4 Participants |
| Race/Ethnicity, Customized Other | 0 Participants | 0 participants | 1 participants | 1 participants | 0 participants | 0 participants | 0 participants | 2 participants |
| Race/Ethnicity, Customized White/Caucasian | 4 participants | 3 participants | 19 participants | 17 participants | 23 participants | 9 participants | 4 participants | 79 participants |
| Sex: Female, Male Female | 2 Participants | 3 Participants | 14 Participants | 12 Participants | 17 Participants | 3 Participants | 2 Participants | 53 Participants |
| Sex: Female, Male Male | 2 Participants | 1 Participants | 8 Participants | 6 Participants | 6 Participants | 9 Participants | 2 Participants | 34 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 | 1 / 4 | 0 / 4 | 2 / 22 | 4 / 18 | 2 / 23 | 3 / 12 | 0 / 4 |
| other Total, other adverse events | 4 / 4 | 4 / 4 | 21 / 22 | 17 / 18 | 22 / 23 | 10 / 12 | 4 / 4 |
| serious Total, serious adverse events | 1 / 4 | 1 / 4 | 8 / 22 | 9 / 18 | 9 / 23 | 5 / 12 | 1 / 4 |
Outcome results
Primary
Number of Participants With Treatment-related Adverse Events
Adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug/treatment
Time frame: From screening through 60 days after end of treatment, up to 11 months
Population: The Full Analysis Set population include all subjects enrolled in the study who received at least 1 dose of INCAGN01949.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PART 1 Dose 1 (7 mg) | Number of Participants With Treatment-related Adverse Events | 4 Participants |
| PART 1 Dose 2 (20 mg) | Number of Participants With Treatment-related Adverse Events | 4 Participants |
| PART 1 Dose 3 (70 mg) | Number of Participants With Treatment-related Adverse Events | 21 Participants |
| PART 1 Dose 4 (200 mg) | Number of Participants With Treatment-related Adverse Events | 17 Participants |
| PART 1 Dose 5 (350 mg) | Number of Participants With Treatment-related Adverse Events | 22 Participants |
| PART 1 Dose 6 (700 mg) | Number of Participants With Treatment-related Adverse Events | 11 Participants |
| PART 1 Dose 7 (1400 mg) | Number of Participants With Treatment-related Adverse Events | 4 Participants |
Secondary
Area Under the Single-dose Concentration-time Curve (AUC0-t) of INCAGN01949
To evaluate the AUC0-t of INCAGN01949 in subjects with advanced or metastatic solid tumors
Time frame: Pre-infusion for cycles 1,2,3,4,5,6 and 7, 10-minutes, 4 hrs, 24 hrs post-infusion, Day 8 for cycles 1 & 6
Population: The PK evaluable population will include all subjects who received at least 1 dose of INCAGN01949 and provided at least 1 post dose sample (1 PK measurement).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| PART 1 Dose 1 (7 mg) | Area Under the Single-dose Concentration-time Curve (AUC0-t) of INCAGN01949 | cycle 6 | 427 ug*hr/mL | Standard Deviation 9.21 |
| PART 1 Dose 1 (7 mg) | Area Under the Single-dose Concentration-time Curve (AUC0-t) of INCAGN01949 | cycle 1 | 185 ug*hr/mL | Standard Deviation 81.7 |
| PART 1 Dose 2 (20 mg) | Area Under the Single-dose Concentration-time Curve (AUC0-t) of INCAGN01949 | cycle 1 | 904 ug*hr/mL | Standard Deviation 197 |
| PART 1 Dose 3 (70 mg) | Area Under the Single-dose Concentration-time Curve (AUC0-t) of INCAGN01949 | cycle 6 | 5490 ug*hr/mL | Standard Deviation 1560 |
| PART 1 Dose 3 (70 mg) | Area Under the Single-dose Concentration-time Curve (AUC0-t) of INCAGN01949 | cycle 1 | 2370 ug*hr/mL | Standard Deviation 841 |
| PART 1 Dose 4 (200 mg) | Area Under the Single-dose Concentration-time Curve (AUC0-t) of INCAGN01949 | cycle 6 | 10700 ug*hr/mL | Standard Deviation 6560 |
| PART 1 Dose 4 (200 mg) | Area Under the Single-dose Concentration-time Curve (AUC0-t) of INCAGN01949 | cycle 1 | 5400 ug*hr/mL | Standard Deviation 1820 |
| PART 1 Dose 5 (350 mg) | Area Under the Single-dose Concentration-time Curve (AUC0-t) of INCAGN01949 | cycle 1 | 10000 ug*hr/mL | Standard Deviation 5600 |
| PART 1 Dose 6 (700 mg) | Area Under the Single-dose Concentration-time Curve (AUC0-t) of INCAGN01949 | cycle 1 | 28300 ug*hr/mL | Standard Deviation 7720 |
| PART 1 Dose 7 (1400 mg) | Area Under the Single-dose Concentration-time Curve (AUC0-t) of INCAGN01949 | cycle 1 | 61600 ug*hr/mL | Standard Deviation 9130 |
Secondary
Duration of Disease Control Per RECIST and Modified RECIST
ORR was defined as the percentage of participants who had a confirmed complete response (CR) or partial response (PR) per RECIST v1.1 and mRECIST v1.1. by investigator determination.
Time frame: Baseline and every 8 weeks, up to 11 months
Population: The Full Analysis Set population include all subjects enrolled in the study who received at least 1 dose of INCAGN01949. Median was not estimable due to insufficient number of participants with CR, PR, and SD
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| PART 1 Dose 1 (7 mg) | Duration of Disease Control Per RECIST and Modified RECIST | 0 Days |
| PART 1 Dose 2 (20 mg) | Duration of Disease Control Per RECIST and Modified RECIST | 57 Days |
| PART 1 Dose 3 (70 mg) | Duration of Disease Control Per RECIST and Modified RECIST | 64 Days |
| PART 1 Dose 4 (200 mg) | Duration of Disease Control Per RECIST and Modified RECIST | 57 Days |
| PART 1 Dose 5 (350 mg) | Duration of Disease Control Per RECIST and Modified RECIST | NA Days |
| PART 1 Dose 6 (700 mg) | Duration of Disease Control Per RECIST and Modified RECIST | 120 Days |
Secondary
Duration of Response Per RECIST and Modified RECIST
ORR was defined as the percentage of participants who had a confirmed complete response (CR) or partial response (PR) per RECIST v1.1 and mRECIST v1.1. by investigator determination.
Time frame: Baseline and every 8 weeks, up to 11 months
Population: The Full Analysis Set population included all subjects enrolled in the study who received at least 1 dose of INCAGN01949. Median was not estimable due to insufficient number of participants with response
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| PART 1 Dose 6 (700 mg) | Duration of Response Per RECIST and Modified RECIST | 192 days | Full Range 192 |
Secondary
Maximum Observed Concentration (Cmax) of INCAGN01949 in Plasma
To evaluate the Cmax of INCAGN01949 in subjects with advanced or metastatic solid tumors.
Time frame: Pre-infusion for cycles 1,2,3,4,5,6 and 7, 10-minutes, 4 hrs, 24 hrs post-infusion, Day 8 for cycles 1 & 6
Population: The PK evaluable population will include all subjects who received at least 1 dose of INCAGN01949 and provided at least 1 post dose sample (1 PK measurement).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PART 1 Dose 1 (7 mg) | Maximum Observed Concentration (Cmax) of INCAGN01949 in Plasma | 1630 ng/ml | Standard Deviation 735 |
| PART 1 Dose 2 (20 mg) | Maximum Observed Concentration (Cmax) of INCAGN01949 in Plasma | 5820 ng/ml | Standard Deviation 324 |
| PART 1 Dose 3 (70 mg) | Maximum Observed Concentration (Cmax) of INCAGN01949 in Plasma | 22300 ng/ml | Standard Deviation 32800 |
| PART 1 Dose 4 (200 mg) | Maximum Observed Concentration (Cmax) of INCAGN01949 in Plasma | 39200 ng/ml | Standard Deviation 10300 |
| PART 1 Dose 5 (350 mg) | Maximum Observed Concentration (Cmax) of INCAGN01949 in Plasma | 84900 ng/ml | Standard Deviation 76700 |
| PART 1 Dose 6 (700 mg) | Maximum Observed Concentration (Cmax) of INCAGN01949 in Plasma | 207000 ng/ml | Standard Deviation 45500 |
| PART 1 Dose 7 (1400 mg) | Maximum Observed Concentration (Cmax) of INCAGN01949 in Plasma | 347000 ng/ml | Standard Deviation 130000 |
Secondary
Objective Response Rate Per RECIST and Modified RECIST
ORR was defined as the percentage of participants who had a confirmed complete response (CR) or partial response (PR) per RECIST v1.1 and mRECIST v1.1. by investigator determination.
Time frame: Baseline and every 8 weeks,up to 11 months
Population: The Full Analysis Set population include all subjects enrolled in the study who received at least 1 dose of INCAGN01949.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PART 1 Dose 1 (7 mg) | Objective Response Rate Per RECIST and Modified RECIST | 0 Participants |
| PART 1 Dose 2 (20 mg) | Objective Response Rate Per RECIST and Modified RECIST | 0 Participants |
| PART 1 Dose 3 (70 mg) | Objective Response Rate Per RECIST and Modified RECIST | 0 Participants |
| PART 1 Dose 4 (200 mg) | Objective Response Rate Per RECIST and Modified RECIST | 0 Participants |
| PART 1 Dose 5 (350 mg) | Objective Response Rate Per RECIST and Modified RECIST | 0 Participants |
| PART 1 Dose 6 (700 mg) | Objective Response Rate Per RECIST and Modified RECIST | 1 Participants |
| PART 1 Dose 7 (1400 mg) | Objective Response Rate Per RECIST and Modified RECIST | 0 Participants |
Secondary
Progression-free Survival Per RECIST and Modified RECIST
ORR was defined as the percentage of participants who had a confirmed complete response (CR) or partial response (PR) per RECIST v1.1 and mRECIST v1.1. by investigator determination.
Time frame: Baseline and every 8 weeks, up to 11 months
Population: The Full Analysis Set population include all subjects enrolled in the study who received at least 1 dose of INCAGN01949.
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| PART 1 Dose 1 (7 mg) | Progression-free Survival Per RECIST and Modified RECIST | 57 Days | Full Range 55 |
| PART 1 Dose 2 (20 mg) | Progression-free Survival Per RECIST and Modified RECIST | 47.5 Days | Full Range 29 |
| PART 1 Dose 3 (70 mg) | Progression-free Survival Per RECIST and Modified RECIST | 54.0 Days | Full Range 23 |
| PART 1 Dose 4 (200 mg) | Progression-free Survival Per RECIST and Modified RECIST | 56.0 Days | Full Range 26 |
| PART 1 Dose 5 (350 mg) | Progression-free Survival Per RECIST and Modified RECIST | 52.0 Days | Full Range 1 |
| PART 1 Dose 6 (700 mg) | Progression-free Survival Per RECIST and Modified RECIST | 125.0 Days | Full Range 21 |
| PART 1 Dose 7 (1400 mg) | Progression-free Survival Per RECIST and Modified RECIST | 46.5 Days | Full Range 42 |
Secondary
Summary of Trough Concentrations(Cmin) of INCAGN01949
To evaluate the Cmin of INCAGN01949 in subjects with advanced or metastatic solid tumors. Cmin is the minimum observed concentration of INCAGN1949
Time frame: Pre-infusion for cycles 1,2,3,4,5,6 and 7, 10-minutes, 4 hrs, 24 hrs post-infusion, Day 8 for cycles 1 & 6
Population: The PK evaluable population will include all subjects who received at least 1 dose of INCAGN01949 and provided at least 1 post dose sample (1 PK measurement).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PART 1 Dose 1 (7 mg) | Summary of Trough Concentrations(Cmin) of INCAGN01949 | cycle 2 | 303 ng/mL | Standard Deviation 202 |
| PART 1 Dose 1 (7 mg) | Summary of Trough Concentrations(Cmin) of INCAGN01949 | cycle 3 | 753 ng/mL | Standard Deviation 163 |
| PART 1 Dose 1 (7 mg) | Summary of Trough Concentrations(Cmin) of INCAGN01949 | cycle 6 | 785 ng/mL | Standard Deviation 39.6 |
| PART 1 Dose 1 (7 mg) | Summary of Trough Concentrations(Cmin) of INCAGN01949 | cycle 4 | 895 ng/mL | Standard Deviation 80.2 |
| PART 1 Dose 2 (20 mg) | Summary of Trough Concentrations(Cmin) of INCAGN01949 | cycle 3 | 1520 ng/mL | Standard Deviation 225 |
| PART 1 Dose 2 (20 mg) | Summary of Trough Concentrations(Cmin) of INCAGN01949 | cycle 2 | 1890 ng/mL | Standard Deviation 1570 |
| PART 1 Dose 2 (20 mg) | Summary of Trough Concentrations(Cmin) of INCAGN01949 | cycle 4 | 1780 ng/mL | Standard Deviation 318 |
| PART 1 Dose 3 (70 mg) | Summary of Trough Concentrations(Cmin) of INCAGN01949 | cycle 6 | 9150 ng/mL | Standard Deviation 2420 |
| PART 1 Dose 3 (70 mg) | Summary of Trough Concentrations(Cmin) of INCAGN01949 | cycle 7 | 10200 ng/mL | Standard Deviation 2190 |
| PART 1 Dose 3 (70 mg) | Summary of Trough Concentrations(Cmin) of INCAGN01949 | cycle 4 | 5110 ng/mL | Standard Deviation 2850 |
| PART 1 Dose 3 (70 mg) | Summary of Trough Concentrations(Cmin) of INCAGN01949 | cycle 3 | 5620 ng/mL | Standard Deviation 3280 |
| PART 1 Dose 3 (70 mg) | Summary of Trough Concentrations(Cmin) of INCAGN01949 | cycle 2 | 3620 ng/mL | Standard Deviation 1550 |
| PART 1 Dose 4 (200 mg) | Summary of Trough Concentrations(Cmin) of INCAGN01949 | cycle 7 | 21600 ng/mL | Standard Deviation 10600 |
| PART 1 Dose 4 (200 mg) | Summary of Trough Concentrations(Cmin) of INCAGN01949 | cycle 2 | 8880 ng/mL | Standard Deviation 4510 |
| PART 1 Dose 4 (200 mg) | Summary of Trough Concentrations(Cmin) of INCAGN01949 | cycle 3 | 14300 ng/mL | Standard Deviation 7740 |
| PART 1 Dose 4 (200 mg) | Summary of Trough Concentrations(Cmin) of INCAGN01949 | cycle 4 | 17900 ng/mL | Standard Deviation 13200 |
| PART 1 Dose 4 (200 mg) | Summary of Trough Concentrations(Cmin) of INCAGN01949 | cycle 6 | 19600 ng/mL | Standard Deviation 13100 |
| PART 1 Dose 5 (350 mg) | Summary of Trough Concentrations(Cmin) of INCAGN01949 | cycle 3 | 29400 ng/mL | Standard Deviation 18400 |
| PART 1 Dose 5 (350 mg) | Summary of Trough Concentrations(Cmin) of INCAGN01949 | cycle 2 | 17000 ng/mL | Standard Deviation 8040 |
| PART 1 Dose 5 (350 mg) | Summary of Trough Concentrations(Cmin) of INCAGN01949 | cycle 4 | 42200 ng/mL | Standard Deviation 28500 |
| PART 1 Dose 5 (350 mg) | Summary of Trough Concentrations(Cmin) of INCAGN01949 | cycle 6 | 43400 ng/mL | Standard Deviation 26500 |
| PART 1 Dose 6 (700 mg) | Summary of Trough Concentrations(Cmin) of INCAGN01949 | cycle 2 | 41000 ng/mL | Standard Deviation 13000 |
| PART 1 Dose 6 (700 mg) | Summary of Trough Concentrations(Cmin) of INCAGN01949 | cycle 4 | 84600 ng/mL | Standard Deviation 17700 |
| PART 1 Dose 6 (700 mg) | Summary of Trough Concentrations(Cmin) of INCAGN01949 | cycle 3 | 77800 ng/mL | Standard Deviation 27900 |
| PART 1 Dose 7 (1400 mg) | Summary of Trough Concentrations(Cmin) of INCAGN01949 | cycle 4 | 282000 ng/mL | Standard Deviation 165000 |
| PART 1 Dose 7 (1400 mg) | Summary of Trough Concentrations(Cmin) of INCAGN01949 | cycle 3 | 163000 ng/mL | Standard Deviation 32900 |
| PART 1 Dose 7 (1400 mg) | Summary of Trough Concentrations(Cmin) of INCAGN01949 | cycle 2 | 117000 ng/mL | Standard Deviation 19300 |
Secondary
Time to Maximum Concentration of INCAGN01949 in Plasma
To evaluate the Tmax of INCAGN01949 in subjects with advanced or metastatic solid tumors.
Time frame: Pre-infusion for cycles 1,2,3,4,5,6 and 7, 10-minutes, 4 hrs, 24 hrs post-infusion, Day 8 for cycles 1 & 6
Population: The PK evaluable population will include all subjects who received at least 1 dose of INCAGN01949 and provided at least 1 post dose sample (1 PK measurement).
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| PART 1 Dose 1 (7 mg) | Time to Maximum Concentration of INCAGN01949 in Plasma | cycle 6 | 0.78 hr |
| PART 1 Dose 1 (7 mg) | Time to Maximum Concentration of INCAGN01949 in Plasma | cycle 1 | 0.64 hr |
| PART 1 Dose 2 (20 mg) | Time to Maximum Concentration of INCAGN01949 in Plasma | cycle 1 | 2.53 hr |
| PART 1 Dose 3 (70 mg) | Time to Maximum Concentration of INCAGN01949 in Plasma | cycle 6 | 0.63 hr |
| PART 1 Dose 3 (70 mg) | Time to Maximum Concentration of INCAGN01949 in Plasma | cycle 1 | 4.3 hr |
| PART 1 Dose 4 (200 mg) | Time to Maximum Concentration of INCAGN01949 in Plasma | cycle 6 | 0.61 hr |
| PART 1 Dose 4 (200 mg) | Time to Maximum Concentration of INCAGN01949 in Plasma | cycle 1 | 0.63 hr |
| PART 1 Dose 5 (350 mg) | Time to Maximum Concentration of INCAGN01949 in Plasma | cycle 1 | 0.6 hr |
| PART 1 Dose 6 (700 mg) | Time to Maximum Concentration of INCAGN01949 in Plasma | cycle 1 | 0.7 hr |
| PART 1 Dose 7 (1400 mg) | Time to Maximum Concentration of INCAGN01949 in Plasma | cycle 1 | 0.73 hr |