[M25-219]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

[M25-219]A Phase 1b Dose Escalation and Expansion Study of IMGN151 as Monotherapy and in Combination with other Anti Cancer Therapies in Subjects with Gynecologic Cancers

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2051250091

Enrollment

Registered

2025-08-19

Start date

2025-11-03

Completion date

Unknown

Last updated

2025-10-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ovarian Cancer

Interventions

Arm A: IMGN151 + Carboplatin(For PSOC) Participants will receive IMGN151 in combination with Carboplatin on Day 1 of a 21-day cycle. Arm B: IMGN151 + Olaparib(For PSOC) Participants will receive IMGN

Eligibility

Sex/Gender

Female

Inclusion criteria

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 more than or equal to 1 lesion that meets the definition of measurable disease by RECIST v1.1 (radiographically measured by the investigator). -Participants will have high grade serous epithelial ovarian, fallopian tube, and primary peritoneal cancers (EOC). -Participant has completed prior therapy within the specified times below 1.Systemic antineoplastic therapy within 5 half lives or 4 weeks (whichever is shorter) prior to the first dose of IMGN151. 2.Focal radiation completed more than or equal to 2 weeks prior to the first dose of study treatment.

Exclusion criteria

Exclusion criteria: -Participants with ovarian cancer with histologies including: endometrioid, clear cell, mucinous, or sarcomatous histology, mixed tumors containing any of the above histologies, as well a low grade or borderline ovarian tumor. -History of clinically significant medical conditions or any other reason that the investigator determines would interfere with the participant's participation in this study or would make the participant an unsuitable candidate to receive study treatment. -Prior treatment with FR alpha targeting therapy. -Prior wide field radiotherapy affecting more than 20 percent of the bone marrow.

Design outcomes

Primary

Measure	Time frame
- Number of Participants With Dose-limiting Toxicities (DLTs) - Percentage of Participants with Adverse Events (AE)	—

Secondary

Measure	Time frame
- Objective Response (OR) - Duration of response (DOR) - Progression-free survival (PFS)	—

Countries

China, Israel, Japan, United States of America

Contacts

Public ContactContact for Patients and HCP

AbbVie GK

AbbVie_JPN_info_clingov@abbvie.com+81-120-587-874

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Feb 4, 2026