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New Antibody-Drug combo takes aim at Hard-to-Treat ovarian cancer

NCT ID NCT06843447

Disease control Sponsor: Merck Sharp & Dohme LLC Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 11, 2026 · Updated 9 times

Summary

This study tests a new drug called raludotatug deruxtecan (R-DXd) in people whose high-grade serous ovarian, peritoneal, or fallopian tube cancer has returned after platinum chemotherapy. R-DXd is an antibody-drug conjugate that seeks out cancer cells and delivers a toxic payload directly to them. The trial will check safety and how well the drug shrinks tumors, given alone or with other anticancer agents.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Raludotatug deruxtecan (R-DXd), an antibody-drug conjugate that targets a protein on cancer cells and delivers a chemotherapy-like payload directly to them.
What this could lead to
If this trial succeeds, it could offer a new treatment option for people with relapsed high-grade serous ovarian cancer, potentially shrinking tumors or slowing disease progression.
What could go wrong
This is an early-phase trial (1b/2) with a small number of participants, so results may not apply to everyone. The drug may cause side effects like low blood counts or liver issues, and it might not work better than existing treatments.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 605 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2025

Expected to finish

Feb 2031

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Has pathologically documented diagnosis of high-grade serous or high-grade endometrioid epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer * Participants in Part 1 cohorts and Part 2 Cohort A-2 Arms 1, 2, and 3, Cohort B-2, and Cohort C-2 Arm 3: Has measurable disease per Response Evaluation Criteria In Solid Tumors 1.1 * Participants in Cohort A-1 Arms 2 and 3: Has relapsed disease after 1 to 3 prior lines of therapy and radiographic evidence of disease progression ≥6 months (≥180 days) after the last dose of platinum-based therapy (ie, platinum-sensitive disease) * Participants in Cohort B-1 and Cohort B-2: Has relapsed disease after 1 to 3 prior lines of therapy and radiographic evidence of disease progression \<6 months (\<180 days) after the last dose of platinum-based therapy (ie, platinum-resistant disease). Participants must have received no more than 1 prior bevacizumab-containing systemic treatment regimen * Participants in Cohort B-1, Cohort B-2, Cohort C-2 Arm 3, Cohort E-1 and if administering bevacizumab is planned in Cohort D or Cohort A-2 Arms 1, 2, or 3: Is a candidate for bevacizumab treatment * Has provided tumor tissue for biomarker research (all cohorts) * Has an Eastern Cooperative Oncology Group performance status of 0 to 1 * Participants in Cohort C-1, Cohort C-2 Arm 3, Cohort D, and Cohort E-1: Has relapsed disease after 1 prior line of therapy, radiographic evidence of disease progression ≥6 months (≥180 days) after the last dose of platinum-based therapy (ie, platinum-sensitive disease) and progressed during prior treatment with poly-ADP ribose polymerase inhibitor (PARPi) in the first-line setting * Participants in Cohort A-2 Arms 1, 2, and 3: Has relapsed disease after 1 prior line of therapy and radiographic evidence of disease progression ≥6 months (≥180 days) after the last dose of platinum-based therapy (ie, platinum-sensitive disease) * Participants in Cohort C-2 Arms 1 and 2: Has a new, histologically confirmed diagnosis of International Federation of Gynecology and Obstetrics Stage III or Stage IV epithelial ovarian cancer (high-grade serous or high-grade endometrioid), fallopian tube cancer, or primary peritoneal cancer that is non-homologous recombination deficiency-positive * Participants in Cohort C-2 Arms 1 and 2: According to the investigator's assessment, PARPi first-line maintenance treatment for non- homologous recombination deficiency (HRD)-positive disease is not the preferred option for the participant * Participants in Cohort C-2 Arms 1 and 2: According to the investigator's assessment, bevacizumab treatment for non-HRD-positive disease is not the preferred option for the participant Exclusion Criteria: * Has any of the following within 6 months before allocation/randomization: cerebrovascular accident, transient ischemic attack, or other arterial thromboembolic event * Has uncontrolled or significant cardiovascular disease * Has clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses including, but not limited to, any underlying pulmonary disorder, and any autoimmune, connective tissue, or inflammatory disorders with potential pulmonary involvement, or prior pneumonectomy * Has ≥Grade 2 peripheral neuropathy * Has received prior treatment with cadherin-6-targeted agents * Has received prior systemic anticancer therapy including investigational agents within 4 weeks or 5 half-lives (whichever is shorter) before allocation * Has received prior radiotherapy within 2 weeks of the start of study intervention, or has radiation-related toxicities, requiring corticosteroids * Receives chronic steroid treatment * Has known additional malignancy that is progressing or has required active treatment within the past 3 years * Has known active CNS metastases and/or carcinomatous meningitis * Has any history of interstitial lung disease (ILD)/pneumonitis irrespective of prior steroid use, current ILD, or suspected ILD, or ILD that cannot be ruled out by imaging at screening * Has active infection requiring systemic therapy * HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease

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Conditions

The condition(s) this trial relates to.

fallopian tube cancer ovarian cancer ovarian endometrioid adenocarcinoma ovarian serous adenocarcinoma primary peritoneal carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Ovarian cancer recurrent

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    32 sites in 6 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Barts Health NHS Trust ( Site 0401)

    RECRUITING

    London, London, City of, E1 1RD, United Kingdom

  • CHUV (centre hospitalier universitaire vaudois) ( Site 0800)

    RECRUITING

    Lausanne, Canton of Vaud, 1011, Switzerland

  • Centre Hospitalier de l'Université de Montréal ( Site 0102)

    RECRUITING

    Montreal, Quebec, H2X 0A9, Canada

  • Clinica Universidad de Navarra ( Site 0301)

    RECRUITING

    Madrid, Madrid, Comunidad de, 28027, Spain

  • Dana-Farber Cancer Institute ( Site 0015)

    RECRUITING

    Boston, Massachusetts, 02215, United States

  • Guy s & St Thomas NHS Foundation Trust ( Site 0400)

    RECRUITING

    London, London, City of, SE1 3SS, United Kingdom

  • HOCH Health Ostschweiz ( Site 0801)

    RECRUITING

    Sankt Gallen, 9007, Switzerland

  • HOSPITAL UNIVERSITARIO PUERTA DE HIERRO MAJADAHONDA ( Site 0307)

    RECRUITING

    Majadhonda, Madrid, 28222, Spain

  • Hospital General Universitario de Valencia ( Site 0305)

    RECRUITING

    Valencia, Valenciana, Comunitat, 46014, Spain

  • Hospital Universitari Vall d'Hebron-Departamento de Oncologia- VHIO ( Site 0300)

    RECRUITING

    Barcelona, 08035, Spain

  • Hospital Universitario 12 de Octubre ( Site 0304)

    RECRUITING

    Madrid, 28041, Spain

  • Hospital Universitario Fundación Jiménez Díaz-START Madrid-FJD ( Site 0303)

    RECRUITING

    Madrid, 28040, Spain

  • Hospital Universitario Virgen de la Victoria ( Site 0306)

    RECRUITING

    Málaga, 29010, Spain

  • Houston Methodist Hospital ( Site 0010)

    COMPLETED

    Houston, Texas, 77030, United States

  • Institut Català d'Oncologia - L'Hospitalet ( Site 0302)

    RECRUITING

    L'Hospitalet de Llobregat, Barcelona, 08908, Spain

  • McGill University Health Centre ( Site 0100)

    RECRUITING

    Montreal, Quebec, H4A 3J1, Canada

  • Memorial Sloan Kettering Cancer Center ( Site 0003)

    RECRUITING

    New York, New York, 10065, United States

  • OU Health University of Oklahoma Medical Center ( Site 7000)

    RECRUITING

    Oklahoma City, Oklahoma, 73104, United States

  • Rabin Medical Center ( Site 0203)

    RECRUITING

    Petah Tikva, 4941492, Israel

  • Rambam Health Care Campus ( Site 0202)

    RECRUITING

    Haifa, 3109601, Israel

  • Royal Marsden Hospital ( Site 0402)

    RECRUITING

    Fulham, England, SW3 6JJ, United Kingdom

  • START Mountain Region ( Site 0008)

    RECRUITING

    West Valley City, Utah, 84119, United States

  • Shaare Zedek Medical Center ( Site 0201)

    RECRUITING

    Jerusalem, 9103102, Israel

  • Sheba Medical Center ( Site 0200)

    RECRUITING

    Ramat Gan, 5265601, Israel

  • TRIALS 365 ( Site 0020)

    RECRUITING

    Shreveport, Louisiana, 71103, United States

  • Texas Oncology - DFW ( Site 8000)

    RECRUITING

    Fort Worth, Texas, 76104, United States

  • The Christie NHS Foundation Trust ( Site 0405)

    RECRUITING

    Manchester, M20 4BX, United Kingdom

  • The Royal Marsden NHS Foundation Trust. ( Site 0403)

    RECRUITING

    Sutton, England, SM2 5PT, United Kingdom

  • The University of Louisville, James Graham Brown Cancer Center ( Site 0009)

    RECRUITING

    Louisville, Kentucky, 40202, United States

  • University Hospital Basel-Gynecology & Gynecologic Oncology ( Site 0802)

    RECRUITING

    Basel, Canton of Basel-City, 4031, Switzerland

  • University Hospitals Sussex NHS Foundation Trust ( Site 0404)

    RECRUITING

    Brighton, East Sussex, BN2 1ES, United Kingdom

  • University of Virginia Health System ( Site 0011)

    RECRUITING

    Charlottesville, Virginia, 22908, United States

  • Yale-New Haven Hospital-Smilow Cancer Hospital at Yale-New Haven ( Site 0019)

    RECRUITING

    New Haven, Connecticut, 06510, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.