Recruiting PHASE2 Gynecologic Cancers

New treatment option for Gynecologic Cancers

Official 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

ClinicalTrials.gov ID: NCT07024784

What this study is testing

What is IMGN151?

IMGN151 is an investigational medicine, given as a twice-daily infusion into a vein, being studied as a potential treatment for gynecologic cancers.

Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.

What it's testing
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.
  • Phase 2: a mid-size study of how well it works

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 18 and older, women only

You may be able to join if

  • ECOG performance status of 0 or 1
  • Participants (except for platinum-sensitive ovarian, fallopian tube, and primary peritoneal cancer (PSOC) participants without disease progression...
  • 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.

You likely can't join if

  • Participants with ovarian cancer with histologies including: endometrioid, clear cell, mucinous, or sarcomatous histology, mixed tumors containing...
  • History of clinically significant medical conditions or any other reason that the investigator determines would interfere with the participant's...
  • Prior treatment with FRα-targeting therapy.
  • Prior wide-field radiotherapy affecting more than 20% of the bone marrow.
See the full eligibility criteria
Who can 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)...
  • 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.
What rules you out
  • 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...
  • 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...
  • Prior treatment with FRα-targeting therapy.
  • Prior wide-field radiotherapy affecting more than 20% of the bone marrow.

The study team makes the final eligibility decision.

Where it's taking place

  • Teaneck, New Jersey, United States
  • Cincinnati, Ohio, United States
  • Oklahoma City, Oklahoma, United States
  • Portland, Oregon, United States
  • Providence, Rhode Island, United States
  • Nashville, Tennessee, United States
  • Austin, Texas, United States
  • Fairfax, Virginia, United States
  • Petah Tikva, Central District, Israel
  • Ramat Gan, Tel Aviv, Israel
  • Tel Aviv, Tel Aviv, Israel
  • Haifa, Israel
  • Jerusalem, Israel
  • Akashi-shi, Hyōgo, Japan
  • Chuo-Ku, Tokyo, Japan
  • Koto-ku, Tokyo, Japan

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Teaneck, New Jersey, United States; Cincinnati, Ohio, United States; Oklahoma City, Oklahoma, United States; Portland, Oregon, United States; Providence, Rhode Island, United States; Nashville, Tennessee, United States and 10 more location(s). Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.