Malignant Melanoma
Conditions
Keywords
Melanoma, Phase I, antibody, melanin, tyrosinase related protein 1, glycoprotein, 20D7S
Brief summary
A dose-escalation study designed to determine the safety, maximum tolerated dose (MTD), anti-melanoma activity, antibody blood levels and progression-free survival (PFS) in participants with malignant melanoma receiving IMC-20D7S either every 2 weeks or every 3 weeks.
Interventions
BIOLOGICALIMC-20D7S (Cohort 1A)
5 mg/kg i.v. every 2 weeks. Administered every other week on Days 1 and 15 of each treatment cycle. If no dose-limiting toxicity (DLT) in first 3 participants or 1 DLT in 6 participants, then enrollment into Cohort 2A.
BIOLOGICALIMC-20D7S (Cohort 2A)
10 mg/kg i.v. every 2 weeks. Administered every other week on Days 1 and 15 of each treatment cycle. If no DLT in first 3 participants or 1 DLT in 6 participants in Cohort 2A, then enrollment into Cohort 3A.
BIOLOGICALIMC-20D7S (Cohort 3A)
20 mg/kg i.v. every 2 weeks. Administered every other week on Days 1 and 15 of each treatment cycle. If no DLT in first 3 participants or 1 DLT in 6 participants in Cohort 3A, then enrollment into Cohort 4A.
BIOLOGICALIMC-20D7S (Cohort 4A)
30 mg/kg i.v. every 2 weeks. Administered every other week on Days 1 and 15 of each treatment cycle.
BIOLOGICALIMC-20D7S (Cohort 1B)
10 mg/kg i.v. every 3 weeks. Administered every 3 weeks on Days 1 and 22 of each treatment cycle. If no dose-limiting toxicity (DLT) in first 3 participants or 1 DLT in 6 participants in Cohort 1B, then enrollment into Cohort 2B.
BIOLOGICALIMC-20D7S (Cohort 2B)
20 mg/kg i.v. every 3 weeks. Administered every 3 weeks on Days 1 and 22 of each treatment cycle. If no DLT in first 3 participants or 1 DLT in 6 participants in Cohort 2B, then enrollment into Cohort 3B.
BIOLOGICALIMC-20D7S (Cohort 3B)
30 mg/kg i.v. every 3 weeks. Administered every 3 weeks on Days 1 and 22 of each treatment cycle.
Sponsors
Eli Lilly and Company
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participant has histologically or cytologically confirmed cutaneous, mucosal, or uveal malignant melanoma which has progressed after or during at least 1 treatment with standard cytotoxic treatment or/and immunotherapy \[for example (e.g.), treatment with cytokines, monoclonal antibodies, and vaccines\] and is not regarded to be a candidate for a potentially curative, higher priority treatment for melanoma * Participant is ≥18 years of age * Participant has either measurable disease as defined by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) or evaluable disease * At least 21 days must have elapsed from major surgery, prior chemotherapy, prior treatment with an investigational agent or device, or prior radiation therapy. Relative to participant's treatment with non-approved biological products (eg, monoclonal antibodies), a minimum of 2 half-lives must have passed for eligibility to be considered * Participant has resolution of all clinically significant toxic effects of prior cancer therapy to Grade ≤1 according to National Cancer Institute Common Terminology Criteria for Adverse Events version 4.02 (NCI-CTCAE v4.02) * Participant has adequate hematological function, hepatic function, and renal function
Exclusion criteria
* Participant has undergone major surgery \[e.g., laparotomy, thoracotomy, removal of organ(s)\] within 21 days prior to study entry * Participant has elective or planned surgery to be conducted during the trial * Participant has documented and/or symptomatic brain or leptomeningeal metastases * Participant is receiving systemic steroids or other immunosuppressive medications. (Intermittent use of steroid-containing medications e.g., for asthma exacerbation or for skin lesions is permitted) * Participant has an uncontrolled undercurrent illness * Participant has a concurrent active malignancy other than adequately treated nonmelanomatous skin cancer or other noninvasive carcinoma or in situ neoplasm * Participant has a known allergy to any of the treatment components (monoclonal antibodies or other therapeutic proteins such as fresh frozen plasma, human serum albumin, cytokines, or interleukins). In the event that there is suspicion the participant may have allergies, the participant should be excluded * Participant is pregnant or lactating * Participant has known human immunodeficiency virus (HIV) or acquired immune deficiency syndrome (AIDS) infection
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum Tolerated Dose (MTD) of IMC-20D7S | Baseline to toxicity [up to end of Cycle 1 (4 or 6-week cycles)] | The MTD was defined as the dose preceding the dose level at which 2 participants experienced a dose-limiting toxicity (DLT) during treatment Cycle 1. A DLT was defined as any Grade 3 or above toxicity that emerged during study treatment and was clearly not attributable to malignant melanoma or co-medication and was possibly, probably, or definitely related to IMC-20D7S in the judgment of the investigator. No DLT was observed in the study; a provisional MTD was established. |
| Number of Participants With Serious Adverse Events (SAEs), Other Non-Serious Adverse Events (AEs), or Death | Baseline through 30 days post last dose (up to 31 weeks) | A summary of SAEs and other non-serious AEs, regardless of causality, is located in the Reported Adverse Event module. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| IMC-20D7S PK: Half-life (t½) | Cycles 1 and 3: Prior to, immediately after, and 0.5, 1, 2, 4, 8, 24, 48 (Cycle 3 only), 96, 168, 240, and 336 h post first infusion. Cycles 2 and 4: Prior to and 1 h post first infusion. | A non-validated assay was used to determine individual serum concentrations of IMC-20D7S. Thus, analyses of PK data were not conducted. |
| IMC-20D7S PK: Clearance (Cl) | Cycles 1 and 3: Prior to, immediately after, and 0.5, 1, 2, 4, 8, 24, 48 (Cycle 3 only), 96, 168, 240, and 336 h post first infusion. Cycles 2 and 4: Prior to and 1 h post first infusion. | A non-validated assay was used to determine individual serum concentrations of IMC-20D7S. Thus, analyses of PK data were not conducted. |
| IMC-20D7S PK: Area Under the Concentration Versus Time Curve (AUC) | Cycles 1 and 3: Prior to, immediately after, and 0.5, 1, 2, 4, 8, 24, 48 (Cycle 3 only), 96, 168, 240, and 336 h post first infusion. Cycles 2 and 4: Prior to and 1 h post first infusion. | A non-validated assay was used to determine individual serum concentrations of IMC-20D7S. Thus, analyses of PK data were not conducted. |
| IMC-20D7S Pharmacokinetics (PK): Maximum Concentration (Cmax) | Cycles 1 and 3: Prior to, immediately after, and 0.5, 1, 2, 4, 8, 24, 48 (Cycle 3 only), 96, 168, 240, and 336 hours (h) post first infusion. Cycles 2 and 4: Prior to and 1 h post first infusion. | A non-validated assay was used to determine individual serum concentrations of IMC-20D7S. Thus, analyses of PK data were not conducted. |
| Number of Participants Who Develop Antibodies Against IMC-20D7S (Immunogenicity) | Prior to the first and second infusion in each cycle up to Cycle 7 (4- and 6-week cycles) | Planned analyses for immunogenicity were not completed. A decision was made not to develop a validated immunogenicity assay because of the exploratory nature of the study and the analyses. |
| Progression-Free Survival (PFS) | First dose to disease progression or death (up to 27 weeks) | PFS was determined for participants who went beyond their first disease assessment and completed at least 1 treatment beyond Week 1 of treatment Cycle 3. |
| Recommend Doses for Phase 2/3 Studies Based on MTD | Baseline to toxicity [up to end of Cycle 1 (4-or 6-week cycles)] | It was decided for administrative reasons to discontinue dosing at the provisional MTD rather than progress to Phase 1b. |
| IMC-20D7S PK: Volume of Distribution (Vd) at Steady State | Cycles 1 and 3: Prior to, immediately after, and 0.5, 1, 2, 4, 8, 24, 48 (Cycle 3 only), 96, 168, 240, and 336 h post first infusion. Cycles 2 and 4: Prior to and 1 h post first infusion. | A non-validated assay was used to determine individual serum concentrations of IMC-20D7S. Thus, analyses of PK data were not conducted. |
| IMC-20D7S PK: Minimal Concentration (Cmin) | Cycles 1 and 3: Prior to, immediately after, and 0.5, 1, 2, 4, 8, 24, 48 (Cycle 3 only), 96, 168, 240, and 336 h post first infusion. Cycles 2 and 4: Prior to and 1 h post first infusion. | A non-validated assay was used to determine individual serum concentrations of IMC-20D7S. Thus, analyses of PK data were not conducted. |
Countries
United States
Participant flow
Pre-assignment details
A completed participant (pt) finished the first 4 or 6 weeks of therapy or discontinued due to toxicity. Cohort (C)1A pts were treated sequentially. The next cohort started when all pts finished Cycle 1 of current cohort. Cohorts 1B-3B started if supported by C1A and C2A pharmacokinetic (PK) data and if maximum tolerated dose (MTD) not established.
Participants by arm
| Arm | Count |
|---|---|
| Cohort 1A (5 mg/kg, q2w) IMC-20D7S: 5 mg/kg IMC-20D7S administered i.v. as an infusion q2w on Days 1 and 15 of each 4-week treatment cycle until disease progression, unacceptable toxicity, or other withdrawal criteria were met. There were ≥7 days between the start of treatment for each participant in this cohort. | 3 |
| Cohort 2A (10 mg/kg, q2w) IMC-20D7S: 10 mg/kg IMC-20D7S administered i.v. as an infusion q2w on Days 1 and 15 of each 4-week treatment cycle until disease progression, unacceptable toxicity, or other withdrawal criteria were met. | 3 |
| Cohort 3A (20 mg/kg, q2w) IMC-20D7S: 20 mg/kg IMC-20D7S administered i.v. as an infusion q2w on Days 1 and 15 of each 4-week treatment cycle until disease progression, unacceptable toxicity, or other withdrawal criteria were met. | 8 |
| Cohort 4A (30 mg/kg, q2w) IMC-20D7S: 30 mg/kg IMC-20D7S administered i.v. as an infusion q2w on Days 1 and 15 of each 4-week treatment cycle until disease progression, unacceptable toxicity, or other withdrawal criteria were met. | 3 |
| Cohort 1B (10 mg/kg, q3w) IMC-20D7S: 10 mg/kg IMC-20D7S administered i.v. as an infusion q3w on Days 1 and 22 of each 6-week treatment cycle until disease progression, unacceptable toxicity, or other withdrawal criteria were met. | 3 |
| Cohort 2B (20 mg/kg, q3w) IMC-20D7S: 20 mg/kg IMC-20D7S administered i.v. as an infusion q3w on Days 1 and 22 of each 6-week treatment cycle until disease progression, unacceptable toxicity, or other withdrawal criteria were met. | 4 |
| Cohort 3B (30 mg/kg, q3w) IMC-20D7S: 30 mg/kg IMC-20D7S administered i.v. as an infusion q3w on Days 1 and 22 of each 6-week treatment cycle until disease progression, unacceptable toxicity, or other withdrawal criteria were met. | 3 |
| Total | 27 |
Baseline characteristics
| Characteristic | Cohort 1A (5 mg/kg, q2w) | Total | Cohort 3B (30 mg/kg, q3w) | Cohort 2B (20 mg/kg, q3w) | Cohort 1B (10 mg/kg, q3w) | Cohort 4A (30 mg/kg, q2w) | Cohort 3A (20 mg/kg, q2w) | Cohort 2A (10 mg/kg, q2w) |
|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 77.7 years STANDARD_DEVIATION 5.5 | 68.2 years STANDARD_DEVIATION 9.26 | 65.4 years STANDARD_DEVIATION 18.9 | 69.1 years STANDARD_DEVIATION 5.53 | 66.6 years STANDARD_DEVIATION 4.41 | 61.1 years STANDARD_DEVIATION 11.7 | 69.8 years STANDARD_DEVIATION 8.37 | 64.9 years STANDARD_DEVIATION 4.92 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 3 Participants | 26 Participants | 3 Participants | 4 Participants | 3 Participants | 3 Participants | 7 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 2 Participants | 25 Participants | 3 Participants | 4 Participants | 3 Participants | 3 Participants | 8 Participants | 2 Participants |
| Region of Enrollment United States | 3 participants | 27 participants | 3 participants | 4 participants | 3 participants | 3 participants | 8 participants | 3 participants |
| Sex: Female, Male Female | 2 Participants | 11 Participants | 2 Participants | 1 Participants | 1 Participants | 1 Participants | 3 Participants | 1 Participants |
| Sex: Female, Male Male | 1 Participants | 16 Participants | 1 Participants | 3 Participants | 2 Participants | 2 Participants | 5 Participants | 2 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 | 8 / 8 | 3 / 3 | 2 / 3 | 4 / 4 | 3 / 3 |
| serious Total, serious adverse events | 1 / 3 | 1 / 3 | 5 / 8 | 2 / 3 | 0 / 3 | 4 / 4 | 0 / 3 |
Outcome results
Primary
Maximum Tolerated Dose (MTD) of IMC-20D7S
The MTD was defined as the dose preceding the dose level at which 2 participants experienced a dose-limiting toxicity (DLT) during treatment Cycle 1. A DLT was defined as any Grade 3 or above toxicity that emerged during study treatment and was clearly not attributable to malignant melanoma or co-medication and was possibly, probably, or definitely related to IMC-20D7S in the judgment of the investigator. No DLT was observed in the study; a provisional MTD was established.
Time frame: Baseline to toxicity [up to end of Cycle 1 (4 or 6-week cycles)]
Population: Participants who completed Cycle 1 of treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| IMC-20D7S | Maximum Tolerated Dose (MTD) of IMC-20D7S | 20 mg/kg q2w |
Primary
Number of Participants With Serious Adverse Events (SAEs), Other Non-Serious Adverse Events (AEs), or Death
A summary of SAEs and other non-serious AEs, regardless of causality, is located in the Reported Adverse Event module.
Time frame: Baseline through 30 days post last dose (up to 31 weeks)
Population: Participants who received any amount of IMC-20D7S .
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| IMC-20D7S | Number of Participants With Serious Adverse Events (SAEs), Other Non-Serious Adverse Events (AEs), or Death | Deaths | 0 participants |
| IMC-20D7S | Number of Participants With Serious Adverse Events (SAEs), Other Non-Serious Adverse Events (AEs), or Death | Other Non-Serious AEs | 3 participants |
| IMC-20D7S | Number of Participants With Serious Adverse Events (SAEs), Other Non-Serious Adverse Events (AEs), or Death | SAEs | 1 participants |
| Cohort 2A (10 mg/kg, q2w) | Number of Participants With Serious Adverse Events (SAEs), Other Non-Serious Adverse Events (AEs), or Death | Deaths | 0 participants |
| Cohort 2A (10 mg/kg, q2w) | Number of Participants With Serious Adverse Events (SAEs), Other Non-Serious Adverse Events (AEs), or Death | SAEs | 1 participants |
| Cohort 2A (10 mg/kg, q2w) | Number of Participants With Serious Adverse Events (SAEs), Other Non-Serious Adverse Events (AEs), or Death | Other Non-Serious AEs | 3 participants |
| Cohort 3A (20 mg/kg, q2w) | Number of Participants With Serious Adverse Events (SAEs), Other Non-Serious Adverse Events (AEs), or Death | Other Non-Serious AEs | 8 participants |
| Cohort 3A (20 mg/kg, q2w) | Number of Participants With Serious Adverse Events (SAEs), Other Non-Serious Adverse Events (AEs), or Death | SAEs | 5 participants |
| Cohort 3A (20 mg/kg, q2w) | Number of Participants With Serious Adverse Events (SAEs), Other Non-Serious Adverse Events (AEs), or Death | Deaths | 0 participants |
| Cohort 4A (30 mg/kg, q2w) | Number of Participants With Serious Adverse Events (SAEs), Other Non-Serious Adverse Events (AEs), or Death | Other Non-Serious AEs | 3 participants |
| Cohort 4A (30 mg/kg, q2w) | Number of Participants With Serious Adverse Events (SAEs), Other Non-Serious Adverse Events (AEs), or Death | SAEs | 2 participants |
| Cohort 4A (30 mg/kg, q2w) | Number of Participants With Serious Adverse Events (SAEs), Other Non-Serious Adverse Events (AEs), or Death | Deaths | 0 participants |
| Cohort 1B (10 mg/kg, q3w) | Number of Participants With Serious Adverse Events (SAEs), Other Non-Serious Adverse Events (AEs), or Death | SAEs | 0 participants |
| Cohort 1B (10 mg/kg, q3w) | Number of Participants With Serious Adverse Events (SAEs), Other Non-Serious Adverse Events (AEs), or Death | Other Non-Serious AEs | 2 participants |
| Cohort 1B (10 mg/kg, q3w) | Number of Participants With Serious Adverse Events (SAEs), Other Non-Serious Adverse Events (AEs), or Death | Deaths | 0 participants |
| Cohort 2B (20 mg/kg, q3w) | Number of Participants With Serious Adverse Events (SAEs), Other Non-Serious Adverse Events (AEs), or Death | Other Non-Serious AEs | 4 participants |
| Cohort 2B (20 mg/kg, q3w) | Number of Participants With Serious Adverse Events (SAEs), Other Non-Serious Adverse Events (AEs), or Death | SAEs | 4 participants |
| Cohort 2B (20 mg/kg, q3w) | Number of Participants With Serious Adverse Events (SAEs), Other Non-Serious Adverse Events (AEs), or Death | Deaths | 0 participants |
| Cohort 3B (30 mg/kg, q3w) | Number of Participants With Serious Adverse Events (SAEs), Other Non-Serious Adverse Events (AEs), or Death | Other Non-Serious AEs | 3 participants |
| Cohort 3B (30 mg/kg, q3w) | Number of Participants With Serious Adverse Events (SAEs), Other Non-Serious Adverse Events (AEs), or Death | SAEs | 0 participants |
| Cohort 3B (30 mg/kg, q3w) | Number of Participants With Serious Adverse Events (SAEs), Other Non-Serious Adverse Events (AEs), or Death | Deaths | 0 participants |
Secondary
IMC-20D7S Pharmacokinetics (PK): Maximum Concentration (Cmax)
A non-validated assay was used to determine individual serum concentrations of IMC-20D7S. Thus, analyses of PK data were not conducted.
Time frame: Cycles 1 and 3: Prior to, immediately after, and 0.5, 1, 2, 4, 8, 24, 48 (Cycle 3 only), 96, 168, 240, and 336 hours (h) post first infusion. Cycles 2 and 4: Prior to and 1 h post first infusion.
Population: No participant was analyzed.
Secondary
IMC-20D7S PK: Area Under the Concentration Versus Time Curve (AUC)
A non-validated assay was used to determine individual serum concentrations of IMC-20D7S. Thus, analyses of PK data were not conducted.
Time frame: Cycles 1 and 3: Prior to, immediately after, and 0.5, 1, 2, 4, 8, 24, 48 (Cycle 3 only), 96, 168, 240, and 336 h post first infusion. Cycles 2 and 4: Prior to and 1 h post first infusion.
Population: No participant was analyzed.
Secondary
IMC-20D7S PK: Clearance (Cl)
A non-validated assay was used to determine individual serum concentrations of IMC-20D7S. Thus, analyses of PK data were not conducted.
Time frame: Cycles 1 and 3: Prior to, immediately after, and 0.5, 1, 2, 4, 8, 24, 48 (Cycle 3 only), 96, 168, 240, and 336 h post first infusion. Cycles 2 and 4: Prior to and 1 h post first infusion.
Population: No participant was analyzed.
Secondary
IMC-20D7S PK: Half-life (t½)
A non-validated assay was used to determine individual serum concentrations of IMC-20D7S. Thus, analyses of PK data were not conducted.
Time frame: Cycles 1 and 3: Prior to, immediately after, and 0.5, 1, 2, 4, 8, 24, 48 (Cycle 3 only), 96, 168, 240, and 336 h post first infusion. Cycles 2 and 4: Prior to and 1 h post first infusion.
Population: No participant was analyzed.
Secondary
IMC-20D7S PK: Minimal Concentration (Cmin)
A non-validated assay was used to determine individual serum concentrations of IMC-20D7S. Thus, analyses of PK data were not conducted.
Time frame: Cycles 1 and 3: Prior to, immediately after, and 0.5, 1, 2, 4, 8, 24, 48 (Cycle 3 only), 96, 168, 240, and 336 h post first infusion. Cycles 2 and 4: Prior to and 1 h post first infusion.
Population: No participant was analyzed.
Secondary
IMC-20D7S PK: Volume of Distribution (Vd) at Steady State
A non-validated assay was used to determine individual serum concentrations of IMC-20D7S. Thus, analyses of PK data were not conducted.
Time frame: Cycles 1 and 3: Prior to, immediately after, and 0.5, 1, 2, 4, 8, 24, 48 (Cycle 3 only), 96, 168, 240, and 336 h post first infusion. Cycles 2 and 4: Prior to and 1 h post first infusion.
Population: No participant was analyzed.
Secondary
Number of Participants Who Develop Antibodies Against IMC-20D7S (Immunogenicity)
Planned analyses for immunogenicity were not completed. A decision was made not to develop a validated immunogenicity assay because of the exploratory nature of the study and the analyses.
Time frame: Prior to the first and second infusion in each cycle up to Cycle 7 (4- and 6-week cycles)
Population: No participant was analyzed.
Secondary
Progression-Free Survival (PFS)
PFS was determined for participants who went beyond their first disease assessment and completed at least 1 treatment beyond Week 1 of treatment Cycle 3.
Time frame: First dose to disease progression or death (up to 27 weeks)
Population: Participants who went beyond their first disease assessment and completed at least one treatment beyond Week 1 of treatment Cycle 3.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| IMC-20D7S | Progression-Free Survival (PFS) | 0 participants |
| Cohort 2A (10 mg/kg, q2w) | Progression-Free Survival (PFS) | 3 participants |
| Cohort 3A (20 mg/kg, q2w) | Progression-Free Survival (PFS) | 2 participants |
| Cohort 4A (30 mg/kg, q2w) | Progression-Free Survival (PFS) | 1 participants |
| Cohort 1B (10 mg/kg, q3w) | Progression-Free Survival (PFS) | 1 participants |
| Cohort 2B (20 mg/kg, q3w) | Progression-Free Survival (PFS) | 1 participants |
| Cohort 3B (30 mg/kg, q3w) | Progression-Free Survival (PFS) | 2 participants |
Secondary
Recommend Doses for Phase 2/3 Studies Based on MTD
It was decided for administrative reasons to discontinue dosing at the provisional MTD rather than progress to Phase 1b.
Time frame: Baseline to toxicity [up to end of Cycle 1 (4-or 6-week cycles)]
Population: No participant was analyzed.