Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
Phase 1: Number of Participants With Dose-limiting Toxicities |
Dose-limiting toxicities were defined as an adverse event or abnormal laboratory value assessed as having a suspected relationship to study drug that occurs within the evaluation period, from the first dose up until Day 28 after the first dose |
Up to 35 months |
|
Primary |
Phase 1: Number of Participants With Adverse Events |
Treatment-emergent adverse events are defined as any adverse event (AE) that started after the first dose of study drug up to 30 days after last dose of study drug, including abnormal laboratory values, vital signs, or electrocardiogram results. AE severity is graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03. |
Up to 35 months |
|
Primary |
Phase 1: Number of Participants With No Dose Interruptions or Reductions |
Tolerability of study treatment was assessed by summarizing the number of participants with no treatment dose interruptions and dose reductions |
Up to 35 months |
|
Primary |
Phase 2: Best Overall Response (BOR) |
Best overall response per RECIST v.1.1 |
Up to 35 months |
|
Secondary |
Phase 2: Number of Participants With Adverse Events |
Treatment-emergent adverse events are defined as any adverse event (AE) that started after the first dose of study drug up to 30 days after last dose of study drug, including abnormal laboratory values, vital signs, or electrocardiogram results. |
Up to 35 months |
|
Secondary |
Phase 2: Number of Participants With No Dose Interruptions or Reductions |
Tolerability of study treatment was assessed by summarizing the number of participants with no treatment dose interruptions and dose reductions |
Up to 35 months |
|
Secondary |
Phase 1: Number of Participants With Best Overall Response (BOR) |
Number of participants with best overall response, including complete response, partial response, stable disease, and progressive disease, based on local Investigator assessment as defined in RECIST v.1.1. |
Up to 35 months |
|
Secondary |
Phase 1 and Phase 2: Progression-free Survival |
Progression-free survival is defined as the time from first dose until the date of objective progression, or death from any cause, whichever occurs first. |
Up to 35 months |
|
Secondary |
Phase 1 and Phase 2: Duration of Response |
Duration of response is defined as the time from the date of first documented objective response (CR or PR) until the date of documented disease progression or death. |
Up to 35 months |
|
Secondary |
Phase 1 and Phase 2: Overall Survival |
Overall Survival is defined as the time (in months) from the date of randomization to the date of death due to any cause. |
Up to 35 months |
|
Secondary |
Area Under the Plasma Concentration-time Curve From Time Zero to the Time of Last Measurable Concentration (AUC0-last) |
|
Predose and 1, 2, 4, 6, 8, and 12 hours post dose on Cycle 1 Day 1 and Cycle 1 Day 15 |
|
Secondary |
Maximum Observed Plasma Drug Concentration After Single Dose Administration (Cmax) |
|
Predose and 1, 2, 4, 6, 8, and 12 hours post dose on Cycle 1 Day 1 and Cycle 1 Day 15 |
|
Secondary |
Time to Reach Maximum Plasma Concentration (Tmax) |
|
Predose and 1, 2, 4, 6, 8, and 12 hours post dose on Cycle 1 Day 1 and Cycle 1 Day 15 |
|
Secondary |
Number of Participants With Anti-IMCnyeso Antibody Formation |
Number of participants with positive treatment-boosted or treatment-induced anti-IMCnyeso antibody titers |
Up to 35 months |
|