A Phase Ib Dose Escalation and Expansion Study of IMGN151 as Monotherapy and in Combination With Other Anti-Cancer Therapies in Subjects With Gynecologic Cancers
Study Identifier:
M25-219
CT.gov Identifier:
EudraCT Identifier:
EU Trial (CTIS) Number:
N/A
Study Contact Information:
Recruiting
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Study Summary
Cancer is a condition where cells in a specific part of body grow and reproduce uncontrollably. The purpose of this study is to assess safety and tolerability of IMGN151 when given as monotherapy and in combination with other anti-cancer therapies in adult participants with gynecologic cancers.
Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
Other
Unmapped
Fallopian Tube
Unmapped
Phase
The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
II
Sex
Female
Age
18+ years
Study Drug
Drug: Experimental: Arm A: IMGN151 + Carboplatin (For PSOC)
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Drug: Drug: Carboplatin
Drug: Experimental: Arm B: IMGN151 + Olaparib (For PSOC)
Drug: Drug: Olaparib
Drug: Experimental: Arm C: IMGN151 + Bevacizumab (For PSOC or PROC)
Drug: Drug: Bevacizumab
Drug: Experimental: Arm D: IMGN151 Monotherapy (For PSOC)
Drug: Experimental: Arm E: IMGN151 Monotherapy (For PROC in China)
Drug: Drug: IMGN151
Drug: Experimental: Arm F: IMGN151 Monotherapy (For PROC in Japan)
Drug: Participants will receive intravenous infusions of IMGN151 as monotherapy or in combination with anti-cancer therapies according to their assigned study arm. In Arm A, participants will receive IMGN151 in combination with carboplatin on Day 1 of each cycle. In Arm B, participants will receive IMGN151 in combination with olaparib, twice a day (BID) on Day 1 of each cycle. In Arm C, participants will receive IMGN151 in combination with bevacizumab on Day 1 of each cycle. In Arm D, participants will receive IMGN151 as monotherapy on Day 1 of each cycle.
Study Status
Indicates the current recruitment status or the expanded access status
Recruiting
Requirements information
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 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:
- * Systemic antineoplastic therapy within 5 half-lives or 4 weeks (whichever is shorter) prior to the first dose of IMGN151.
- * Focal radiation completed ≥ 2 weeks prior to the first dose of study treatment.
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-targeting therapy.
- * Prior wide-field radiotherapy affecting more than 20% of the bone marrow.
Clinical Study Information for Healthcare Providers
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Study Locations
Location
Investigator
Status
Condition(s) Treated at Site
Location
START Los Angeles
Los Angeles, CA, United States, 90025
Investigator
Navid Hafez
Status
Will Be Recruiting
Condition(s) Treated at Site
Other
Unmapped
Fallopian Tube
Unmapped