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
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: IMGN151, Carboplatin, Bevacizumab, Olaparib.
- Who it may be relevant to
- Registry conditions: Gynecologic Cancers, Platinum-Sensitive Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Cancer (PSOC). Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Israel, Japan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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. IMGN151 is an investigational drug being developed for the treatment of gynecologic cancers. Participants are placed in 1 of 4 groups, called treatment arms. Each group receives a different treatment. Around 377 participants with gynecologic cancers will be enrolled in the study at approximately 50 sites worldwide. 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. In Arm E, participants will receive IMGN151 as monotherapy on Day 1 of each cycle. In Arm F, participants will receive IMGN151 as monotherapy on Day 1 of each cycle. The total study duration will be approximately 3 years. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic and may require frequent medical assessments, blood tests, and scans.
Interventions
- Drug IMGN151
Intravenous (IV) infusion - Drug Carboplatin
Intravenous (IV) infusion - Drug Bevacizumab
Intravenous (IV) infusion - Drug Olaparib
Oral Tablet
Primary outcome measures
- Number of Participants With Dose-limiting Toxicities (DLTs) [Time frame: Up to approximately 3 years]
- Percentage of Participants with Adverse Events (AE) [Time frame: Up to approximately 3 years]
Secondary outcome measures (3)
- Objective Response (OR) [Time frame: Up to approximately 3 years]
- Duration of response (DOR) [Time frame: Up to approximately 3 years]
- Progression-free survival (PFS) [Time frame: Up to approximately 3 years]
Eligibility 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 ≥ 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 FRα-targeting therapy.
- Prior wide-field radiotherapy affecting more than 20% of the bone marrow.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 8 centers
- Holy Name Medical Center /ID# 279017 — Teaneck
- University of Cincinnati Medical Center. /ID# 278925 — Cincinnati
- OU Health - Stephenson Cancer Center /ID# 277656 — Oklahoma City
- Providence Portland Medical Center /ID# 277727 — Portland
- Women & Infants Hospital /ID# 277930 — Providence
- SCRI Oncology Partners /ID# 279733 — Nashville
- Texas Oncology-Austin North /ID# 279958 — Austin
- Next Virginia /ID# 279684 — Fairfax
Israel · 5 centers
- Rabin Medical Center /ID# 279142 — Petah Tikva
- The Chaim Sheba Medical Center /ID# 275997 — Ramat Gan
- Tel Aviv Sourasky Medical Center /ID# 275852 — Tel Aviv
- Rambam Health Care Campus- Haifa /ID# 276004 — Haifa
- Shaare Zedek Medical Center /ID# 275854 — Jerusalem
Japan · 3 centers
- Hyogo Cancer Center /ID# 276940 — Akashi-shi
- National Cancer Center Hospital /ID# 276715 — Chuo-Ku
- The Cancer Institute Hospital Of JFCR /ID# 276711 — Koto-ku
Identifiers
NCT: NCT07024784 · M25-219 · GOG-3124