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New hope for tough ovarian cancer: targeted drug shows promise in trial

NCT ID NCT05613088

Disease control Sponsor: Bristol-Myers Squibb Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This study tested a new drug, farletuzumab ecteribulin, which targets a protein found on many ovarian cancer cells. It was compared to standard chemotherapy in 106 women whose ovarian cancer had stopped responding to platinum-based treatments. The goal was to see if the new drug could shrink tumors more effectively and with fewer side effects.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

106 people

The number who actually took part.

Started

Feb 2023

Finished

Sep 2025

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: * Female participants with histologically-confirmed diagnosis of HGS ovarian, primary peritoneal, or fallopian tube cancer. * Platinum-resistant disease, defined as: * For participants who had only 1 line of platinum-based therapy: progression between \> 1 month and ≤ 6 months after the last dose of platinum-based therapy of at least 4 cycles. * For participants who had 2 or 3 lines of platinum-based therapy: progression ≤ 6 months after the last dose of platinum-based therapy. * Participants have received at least 1 but no more than 3 prior lines of systemic therapy and for whom single-agent therapy is appropriate as the next line of therapy. Participants may have been treated with up to 1 line of therapy subsequent to determination of platinum-resistance. * Disease progression per RECIST v1.1 (by investigator assessment) of at least 1 measurable lesion on or after the most recent therapy. * Either formalin-fixed, paraffin-embedded (FFPE) tissue (up to 5 years old) or newly-obtained biopsies must be available for FRα assessment prior to randomization. * Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1. Exclusion Criteria: Medical Conditions * Clear cell, mucinous, endometrioid or sarcomatous histology, or mixed tumors containing components of any of these histologies, or low grade or borderline ovarian cancer. * Primary platinum-refractory ovarian cancer defined as disease progression within 1 month of the last dose of the first line platinum-containing regimen. * Pulmonary function test (PFT) abnormalities: FEV1 \< 70% or FVC \< 60%, and DLCO \< 80%. * Investigator-assessed current ILD/pneumonitis, or ILD/pneumonitis suspected at screening or history of ILD/pneumonitis of any severity including ILD/pneumonitis from prior anti-cancer therapy. * Significant third-space fluid retention (eg, ascites or pleural effusion) that requires repeated drainage. Physical and Laboratory Test Findings * Evidence of organ dysfunction or any clinically-significant deviation from normal in physical examination, vital signs, ECG, or clinical laboratory determinations beyond what is consistent with the target population. Allergies and Adverse Drug Reactions * Has any prior severe hypersensitivity (≥ Grade 3) to monoclonal antibodies or eribulin or contraindication to the receipt of corticosteroids or any of the excipients (investigators should refer to the prescribing information for the selected corticosteroid). * History of allergy or contraindication to IC chemotherapy agent selected if randomized to Arm C. Other protocol-defined inclusion/exclusion criteria apply.

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Conditions

The condition(s) this trial relates to.

Carcinoma, Ovarian Epithelial fallopian tube neoplasm fallopian tube serous adenocarcinoma ovarian cancer ovarian neoplasm ovarian serous adenocarcinoma primary peritoneal carcinoma

As listed by the trial registrant

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

Neoplasms, ovarian

Contacts and locations

Locations

  • Local Institution - 0001

    Madrid, M, 28041, Spain

  • Local Institution - 0002

    Brescia, 25123, Italy

  • Local Institution - 0003

    Bologna, BO, 40138, Italy

  • Local Institution - 0004

    Kurume-Shi, 830-0011, Japan

  • Local Institution - 0005

    Madrid, M, 28007, Spain

  • Local Institution - 0006

    Valencia, V, 46010, Spain

  • Local Institution - 0007

    Valencia, V, 46009, Spain

  • Local Institution - 0009

    Milan, MI, 20141, Italy

  • Local Institution - 0010

    Roma, RM, 00168, Italy

  • Local Institution - 0011

    Milan, MI, 20132, Italy

  • Local Institution - 0012

    Brussels, 1200, Belgium

  • Local Institution - 0013

    Namur, WNA, 5000, Belgium

  • Local Institution - 0014

    Hidaka-shi, 350-1298, Japan

  • Local Institution - 0015

    Clayton, Victoria, 3168, Australia

  • Local Institution - 0016

    Sydney, New South Wales, 2065, Australia

  • Local Institution - 0017

    Waratah, New South Wales, 2298, Australia

  • Local Institution - 0018

    Akashi, Hyogo, 673-8558, Japan

  • Local Institution - 0019

    Chūōku, 104-0045, Japan

  • Local Institution - 0020

    Girona, 17007, Spain

  • Local Institution - 0021

    Barcelona, 08036, Spain

  • Local Institution - 0022

    Madrid, 28046, Spain

  • Local Institution - 0023

    Canton, Ohio, 44710-1702, United States

  • Local Institution - 0025

    San Francisco, California, 94109, United States

  • Local Institution - 0027

    Malvern, Victoria, 3144, Australia

  • Local Institution - 0029

    Temuco, 4800827, Chile

  • Local Institution - 0030

    Santiago, RM, 8420323, Chile

  • Local Institution - 0031

    Chermside, Queensland, 4032, Australia

  • Local Institution - 0032

    Leuven, VBR, 3000, Belgium

  • Local Institution - 0036

    Santiago, 7510032, Chile

  • Local Institution - 0037

    Tokyo, 135-8550, Japan

  • Local Institution - 0038

    Madrid, 28033, Spain

  • Local Institution - 0039

    Barcelona, B, 08035, Spain

  • Local Institution - 0042

    Spokane, Washington, 99204, United States

  • Local Institution - 0043

    Kansas City, Kansas, 66160, United States

  • Local Institution - 0044

    Nashville, Tennessee, 37203-1625, United States

  • Local Institution - 0045

    Liège, 4000, Belgium

  • Local Institution - 0046

    Jerusaelm, JM, 9112001, Israel

  • Local Institution - 0048

    Tel Aviv, 64239, Israel

  • Local Institution - 0049

    Seoul, 03722, South Korea

  • Local Institution - 0053

    Seoul, 5505, South Korea

  • Local Institution - 0054

    Haifa, 31999, Israel

  • Local Institution - 0055

    Ramat Gan, 5265601, Israel

  • Local Institution - 0056

    Seoul, 03080, South Korea

  • Local Institution - 0058

    Nedlands, Western Australia, 6009, Australia

  • Local Institution - 0061

    Columbus, Ohio, 43219, United States

  • Local Institution - 0065

    Sacramento, California, 95817, United States

  • Local Institution - 0078

    Whittier, California, 90602-3171, United States

  • Local Institution - 0080

    Jerusalem, 91031, Israel

  • Local Institution - 0081

    South Bend, Indiana, 46601-1033, United States

  • Local Institution - 0082

    Salt Lake City, Utah, 84124, United States

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