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Gynecologic CancersPhase 2NCT07024784

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

A Phase 2 study testing IMGN151, Carboplatin and Bevacizumab in people with Gynecologic Cancers and Platinum-Sensitive Ovarian Cancer, run by AbbVie at 21 sites in 3 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
IMGN151, Carboplatin and Bevacizumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
377 participants
Where
21 sitesin 3 countries
Study dates
30 Jul 2025to Feb 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

21 sites in 3 countries. Contact the study team or a site near you to ask about taking part.

ABBVIE CALL CENTER contact

844-663-3742

abbvieclinicaltrials@abbvie.com

21 sites in 3 countries

United States13 sites, 13 recruiting

  • University of Colorado Hospital- Aurora /ID# 278232

    Aurora, Colorado, 80045-2527

    Recruiting

  • Texas Oncology-Austin North /ID# 279958

    Austin, Texas, 78758

    Recruiting

  • University of Cincinnati Medical Center. /ID# 278925

    Cincinnati, Ohio, 45219

    Recruiting

  • University Hospitals Cleveland Medical Center /ID# 279601

    Cleveland, Ohio, 44106

    Recruiting

  • Next Virginia /ID# 279684

    Fairfax, Virginia, 22031

    Recruiting

  • Start Los Angeles /ID# 281533

    Los Angeles, California, 90025

    Recruiting

  • University Of Minnesota /ID# 277850

    Minneapolis, Minnesota, 55455

    Recruiting

  • SCRI Oncology Partners /ID# 279733

    Nashville, Tennessee, 37203

    Recruiting

  • OU Health - Stephenson Cancer Center /ID# 277656

    Oklahoma City, Oklahoma, 73104

    Recruiting

  • Providence Portland Medical Center /ID# 277727

    Portland, Oregon, 97213

    Recruiting

  • Women & Infants Hospital /ID# 277930

    Providence, Rhode Island, 02905

    Recruiting

  • SUNY Upstate Medical University - Syracuse /ID# 277305

    Syracuse, New York, 13210

    Recruiting

  • Holy Name Medical Center /ID# 279017

    Teaneck, New Jersey, 07666

    Recruiting

Other trials in United States

Israel5 sites, 5 recruiting

  • Rambam Health Care Campus- Haifa /ID# 276004

    Haifa, 3109601

    Recruiting

  • Shaare Zedek Medical Center /ID# 275854

    Jerusalem, 9103102

    Recruiting

  • Rabin Medical Center /ID# 279142

    Petah Tikva, Central District, 4941492

    Recruiting

  • The Chaim Sheba Medical Center /ID# 275997

    Ramat Gan, Tel Aviv, 5265601

    Recruiting

  • Tel Aviv Sourasky Medical Center /ID# 275852

    Tel Aviv, Tel Aviv, 6423906

    Recruiting

Other trials in Israel

Japan3 sites, 3 recruiting

  • Hyogo Cancer Center /ID# 276940

    Akashi-shi, Hyōgo, 673-8558

    Recruiting

  • National Cancer Center Hospital /ID# 276715

    Chuo-Ku, Tokyo, 104-0045

    Recruiting

  • The Cancer Institute Hospital Of Japanese Foundation for Cancer Research /ID# 276711

    Koto-ku, Tokyo, 135-8550

    Recruiting

Other trials in Japan

About this study

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

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.

Read more

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.

Being tested
IMGN151, Carboplatin, Bevacizumab, Olaparib
Keywords
Gynecologic Cancers, Platinum-Sensitive Ovarian Cancer, Platinum-Resistant Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Cancer (PSOC), Cancer, IMGN151
Medical subject headings
Fallopian Tube Neoplasms, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT07024784
Study groupRoleWhat they receive
Arm A: IMGN151 + Carboplatin (For PSOC)ExperimentalParticipants will receive IMGN151 in combination with Carboplatin on Day 1 of a 21-day cycle.
Receives: Drug: IMGN151; Drug: Carboplatin
Arm B: IMGN151 + Olaparib (For PSOC)ExperimentalParticipants will receive IMGN151 in combination with Olaparib twice a day (BID) on Day 1 of a 21-day cycle.
Receives: Drug: IMGN151; Drug: Olaparib
Arm C: IMGN151 + Bevacizumab (For PSOC or PROC)ExperimentalParticipants will receive IMGN151 in combination with Bevacizumab Day 1 of a 21-day cycle.
Receives: Drug: IMGN151; Drug: Bevacizumab
Arm D: IMGN151 Monotherapy (For PSOC)ExperimentalParticipants will receive IMGN151 Day 1 of a 21-day cycle.
Receives: Drug: IMGN151
Arm E: IMGN151 Monotherapy (For PROC in China)ExperimentalParticipants will receive IMGN151 Day 1 of a 21-day cycle.
Receives: Drug: IMGN151
Arm F: IMGN151 Monotherapy (For PROC in Japan)ExperimentalParticipants will receive IMGN151 Day 1 of a 21-day cycle.
Receives: Drug: IMGN151

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    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.

    Measured: Up to approximately 3 years

  2. Percentage of Participants with Adverse Events (AE)

    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.

    Measured: Up to approximately 3 years

Secondary outcomes (3)

  1. Objective Response (OR)

    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.

    Measured: Up to approximately 3 years

  2. Duration of response (DOR)

    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.

    Measured: Up to approximately 3 years

  3. Progression-free survival (PFS)

    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.

    Measured: Up to approximately 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jun 2025
  2. Study start30 Jul 2025
  3. Primary completionJan 2028 (estimated)
  4. Study completionFeb 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
377 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07024784
Sponsor's protocol ID
M25-219
Other IDs
GOG-3124
Status last verified
Sep 2026
First submitted
9 Jun 2025
Last updated
1 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing IMGN151, Carboplatin and Bevacizumab in people with Gynecologic Cancers and Platinum-Sensitive Ovarian Cancer, run by AbbVie at 21 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 21 sites in United States, Israel, Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact ABBVIE CALL CENTER (844-663-3742, abbvieclinicaltrials@abbvie.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Dose-limiting Toxicities (DLTs) (time frame: Up to approximately 3 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07024784.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2026.

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