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
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Phase
Phase 2
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Recruitment status
Recruiting
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Participants
377
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Lead sponsor
AbbVie
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Start date
2025-07-30
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Number of sites
16
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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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Short title
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
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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
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Control arm
Open label
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Recruiting
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Phase
Phase 2
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Study type
Interventional
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Completion date
2028-02-01
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First posted
2025-06-17
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Registry last updated
2026-06-02
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Primary completion date
2028-01-01
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Start date
2025-07-30
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Participants
377
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Participant count basis
Estimated
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Planned participants
377
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Protocol amendments
4
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Number of sites
16
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Data monitoring committee
No
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Registry sponsor category
Industry
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Lead sponsor
AbbVie
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Source registry
ClinicalTrials.gov
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Registry ID
NCT07024784
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ClinicalTrials.gov ID
NCT07024784
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Registry record
Open registry record
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Allocation
Randomised
Model
Sequential
Purpose
Treatment
Masking
No masking
Sources for study design
clinicaltrials.gov

  1. Number of Participants With Dose-limiting Toxicities (DLTs)

    Timeframe: 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.

  2. Percentage of Participants with Adverse Events (AE)

    Timeframe: 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.

  1. Objective Response (OR)

    Timeframe: 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.

  2. Duration of response (DOR)

    Timeframe: 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.

  3. Progression-free survival (PFS)

    Timeframe: 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.

Sources for outcomes
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Sex
Female
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

  • 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.

  • 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.
Sources for eligibility
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  • Holy Name Medical Center /ID# 279017Teaneck, United StatesRecruiting
  • University of Cincinnati Medical Center. /ID# 278925Cincinnati, United StatesRecruiting
  • OU Health - Stephenson Cancer Center /ID# 277656Oklahoma City, United StatesRecruiting
  • Providence Portland Medical Center /ID# 277727Portland, United StatesRecruiting
  • Women & Infants Hospital /ID# 277930Providence, United StatesRecruiting
  • SCRI Oncology Partners /ID# 279733Nashville, United StatesRecruiting
  • Texas Oncology-Austin North /ID# 279958Austin, United StatesRecruiting
  • Next Virginia /ID# 279684Fairfax, United StatesRecruiting
  • Rabin Medical Center /ID# 279142Petah Tikva, IsraelRecruiting
  • The Chaim Sheba Medical Center /ID# 275997Ramat Gan, IsraelRecruiting
  • Tel Aviv Sourasky Medical Center /ID# 275852Tel Aviv, IsraelRecruiting
  • Rambam Health Care Campus- Haifa /ID# 276004Haifa, IsraelRecruiting
  • Shaare Zedek Medical Center /ID# 275854Jerusalem, IsraelRecruiting
  • Hyogo Cancer Center /ID# 276940Akashi-shi, JapanRecruiting
  • National Cancer Center Hospital /ID# 276715Chuo-Ku, JapanRecruiting
  • The Cancer Institute Hospital Of JFCR /ID# 276711Koto-ku, JapanRecruiting
Sources for sites
clinicaltrials.gov

Other registry identifiers

  • GOG-3124
Sources for references
clinicaltrials.gov

Related records

Drugs (4)

Collaborators (1)

Lead sponsors (1)

Conditions (4)

Targets (4)