| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07024784 | A Study to Assess Change in Disease Activity and Adverse Events in Adult Participants With Gynecologic Cancers Receiving Intravenous Infusion of IMGN151 as Monotherapy or in Combination With Other Therapies | PHASE2 | RECRUITING | 377 | — | — | Jul 30, 2025 | Feb 1, 2028 | Jun 2, 2026 | 16 | United States, Israel +1 |
Dose limiting toxicities (DLTs) of IMGN151 when given as monotherapy and in combination with other anti-cancer therapies DLT events are defined as clinically significant adverse events or abnormal laboratory values assessed as unrelated to disease progression, underlying disease, intercurrent illness, or concomitant medications.
An adverse event (AE) is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with the treatment. The investigator assesses the relationship of each event to the use of study drug.
| Arm | Type | Description |
|---|---|---|
| Arm A: IMGN151 + Carboplatin (For PSOC) | EXPERIMENTAL | Participants will receive IMGN151 in combination with Carboplatin on Day 1 of a 21-day cycle. |
| Arm B: IMGN151 + Olaparib (For PSOC) | EXPERIMENTAL | Participants will receive IMGN151 in combination with Olaparib twice a day (BID) on Day 1 of a 21-day cycle. |
| Arm C: IMGN151 + Bevacizumab (For PSOC or PROC) | EXPERIMENTAL | Participants will receive IMGN151 in combination with Bevacizumab Day 1 of a 21-day cycle. |
| Arm D: IMGN151 Monotherapy (For PSOC) | EXPERIMENTAL | Participants will receive IMGN151 Day 1 of a 21-day cycle. |
| Arm E: IMGN151 Monotherapy (For PROC in China) | EXPERIMENTAL | Participants will receive IMGN151 Day 1 of a 21-day cycle. |
| Arm F: IMGN151 Monotherapy (For PROC in Japan) | EXPERIMENTAL | Participants will receive IMGN151 Day 1 of a 21-day cycle. |
| Name | Type | Description |
|---|---|---|
| IMGN151 | DRUG | Intravenous (IV) infusion |
| Carboplatin | DRUG | Intravenous (IV) infusion |
| Bevacizumab | DRUG | Intravenous (IV) infusion |
| Olaparib | DRUG | Oral Tablet |
Inclusion Criteria: * ECOG performance status of 0 or 1 * Participants (except for platinum-sensitive ovarian, fallopian tube, and primary peritoneal cancer (PSOC) participants without disease progression after platinum combination standard of care therapy in Arms B and D) will have ≥ 1 lesion that...