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

NCT07024784 — Phase 2, Recruiting, 377 participants, AbbVie

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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

RegistryNCT07024784
StatusRecruiting
PhasePhase 2
Study typeInterventional; randomized, sequential, masking: none, treatment
Enrollment377 (Estimated)
SponsorAbbVie (Industry); collaborators: GOG Foundation
ConditionsGynecologic Cancers, Platinum-Sensitive Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Cancer (PSOC)
InterventionsIMGN151, Carboplatin, Bevacizumab, Olaparib (Drug)
Datesstart 2025-07-30, primary completion 2028-01-01 (estimated), completion 2028-02-01 (estimated), first posted 2025-06-17, last updated 2026-10-01
Locations21 sites in United States, Israel, Japan

Related Papers Related Patents Related Grants Related Experts
All trials for Gynecologic Cancers All trials for Platinum-Sensitive Ovarian Cancer All trials of IMGN151 All trials of Carboplatin

-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.

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.

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+Arms and interventions

ArmTypeInterventionsDescription
Arm A: IMGN151 + Carboplatin (For PSOC)ExperimentalDrug: IMGN151; Drug: CarboplatinParticipants will receive IMGN151 in combination with Carboplatin on Day 1 of a 21-day cycle.
Arm B: IMGN151 + Olaparib (For PSOC)ExperimentalDrug: IMGN151; Drug: OlaparibParticipants 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)ExperimentalDrug: IMGN151; Drug: BevacizumabParticipants will receive IMGN151 in combination with Bevacizumab Day 1 of a 21-day cycle.
Arm D: IMGN151 Monotherapy (For PSOC)ExperimentalDrug: IMGN151Participants will receive IMGN151 Day 1 of a 21-day cycle.
Arm E: IMGN151 Monotherapy (For PROC in China)ExperimentalDrug: IMGN151Participants will receive IMGN151 Day 1 of a 21-day cycle.
Arm F: IMGN151 Monotherapy (For PROC in Japan)ExperimentalDrug: IMGN151Participants will receive IMGN151 Day 1 of a 21-day cycle.
  • IMGN151 (Drug): Intravenous (IV) infusion
  • Carboplatin (Drug): Intravenous (IV) infusion
  • Bevacizumab (Drug): Intravenous (IV) infusion
  • Olaparib (Drug): Oral Tablet

+Outcome measures

Primary outcomes

  • Number of Participants With Dose-limiting Toxicities (DLTs) [Up to approximately 3 years]: 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.
  • Percentage of Participants with Adverse Events (AE) [Up to approximately 3 years]: 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.

Secondary outcomes

  • Objective Response (OR) [Up to approximately 3 years]: Defined as achieving confirmed response (complete response \[CR\] + partial response \[PR\]) assessed by the investigator per Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1.
  • Duration of response (DOR) [Up to approximately 3 years]: Defined as the time from initial response of CR or PR until investigator assessed radiographical PD per RECIST v1.1 or death of any cause, whichever occurs first.
  • Progression-free survival (PFS) [Up to approximately 3 years]: Defined as the time from the randomization date for randomized phase or the first dose of study treatment for non-randomized phase until investigator-assessed radiographical PD per RECIST v1.1 or death of any cause, whichever occurs first.

+Eligibility

Sex: Female, ages: 18 Years to any

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.

+Locations (21)

FacilityCityCountryStatus
Start Los Angeles /ID# 281533Los Angeles, CaliforniaUnited StatesRecruiting
University of Colorado Hospital- Aurora /ID# 278232Aurora, ColoradoUnited StatesRecruiting
University Of Minnesota /ID# 277850Minneapolis, MinnesotaUnited StatesRecruiting
Holy Name Medical Center /ID# 279017Teaneck, New JerseyUnited StatesRecruiting
SUNY Upstate Medical University - Syracuse /ID# 277305Syracuse, New YorkUnited StatesRecruiting
University of Cincinnati Medical Center. /ID# 278925Cincinnati, OhioUnited StatesRecruiting
University Hospitals Cleveland Medical Center /ID# 279601Cleveland, OhioUnited StatesRecruiting
OU Health - Stephenson Cancer Center /ID# 277656Oklahoma City, OklahomaUnited StatesRecruiting
Providence Portland Medical Center /ID# 277727Portland, OregonUnited StatesRecruiting
Women & Infants Hospital /ID# 277930Providence, Rhode IslandUnited StatesRecruiting
SCRI Oncology Partners /ID# 279733Nashville, TennesseeUnited StatesRecruiting
Texas Oncology-Austin North /ID# 279958Austin, TexasUnited StatesRecruiting
Next Virginia /ID# 279684Fairfax, VirginiaUnited StatesRecruiting
Rabin Medical Center /ID# 279142Petah Tikva, Central DistrictIsraelRecruiting
The Chaim Sheba Medical Center /ID# 275997Ramat Gan, Tel AvivIsraelRecruiting
Tel Aviv Sourasky Medical Center /ID# 275852Tel Aviv, Tel AvivIsraelRecruiting
Rambam Health Care Campus- Haifa /ID# 276004HaifaIsraelRecruiting
Shaare Zedek Medical Center /ID# 275854JerusalemIsraelRecruiting
Hyogo Cancer Center /ID# 276940Akashi-shi, HyōgoJapanRecruiting
National Cancer Center Hospital /ID# 276715Chuo-Ku, TokyoJapanRecruiting
The Cancer Institute Hospital Of Japanese Foundation for Cancer Research /ID# 276711Koto-ku, TokyoJapanRecruiting

+Investigators

  • ABBVIE INC., Study director, AbbVie