Investigation of Ubamatamab Combination Therapy in Adult Participants With Platinum-Resistant Ovarian Cancer

NCT06787612 · tracked via the Priya Life Science USA tracker

Sponsor

Regeneron Pharmaceuticals

Phase

Phase 2

Started

2025-05-28

Last updated

2026-09-14

Condition(s) studied

Ovarian CancerFallopian Tube CancerPrimary Peritoneal Cancer

Investigational drug(s) / intervention(s)

UbamatamabBevacizumabCemiplimabFianlimabPLDSarilumabREGN10597

Ubamatamab: Administered per the protocol

Bevacizumab: Administered per the protocol

Cemiplimab: Administered per the protocol

Fianlimab: Administered per the protocol

PLD: Administered per the protocol

Sarilumab: Administered per the protocol

REGN10597: Administered per the protocol

Study summary

This study is researching an experimental drug called ubamatamab, also referred to as "study drug". The study is focused on participants who have advanced ovarian cancer.

The aim of the study is to see how safe, tolerable, and effective the study drug is on its own and in combination with other anti-cancer drugs (bevacizumab, cemiplimab, fianlimab, REGN10597 and a standard chemotherapy drug, pegylated liposomal doxorubicin \[PLD\]), referred to as "combination drugs'.

The study is looking at several other research questions, including:

* What side effects may happen from taking the study drug and its experimental combinations
* How much study drug and fianlimab is in the blood at different times
* Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects) and its combinations

Eligibility

Sex

FEMALE

Min age

18 Years

Max age

—

Healthy volunteers

Key Inclusion Criteria: 1. Participants with histologically or cytologically confirmed diagnosis of advanced serous or endometrioid ovarian (regardless of the grade), primary peritoneal, or fallopian tube cancer (clear cell, mucinous, and carcinosarcoma are excluded) 2. Must have progression on prior therapy documented radiographically and must have at least 1 measurable lesion (not previously irradiated) that can be accurately measured by RECIST 1.1 3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 4. Adequate organ and bone marrow function, as described in the protocol 5. Platinum-Resistant Ovarian Cancer, as described in the protocol Key Exclusion Criteria: 1. Major surgical procedure or significant traumatic injury within 4 weeks prior to first dose of study intervention(s) 2. Documented allergic or acute hypersensitivity reaction attributed to antibody treatments or doxorubicin hydrochloride or components of study intervention(s) 3. Another malignancy that is progressing or requires active treatment, as described in the protocol 4. Untreated or active Central Nervous System (CNS) metastases, or carcinomatous meningitis, as described in the protocol 5. Uncontrolled infections including but not limited to human immunodeficiency virus, hepatitis B or hepatitis C infection, or diagnosis of immunodeficiency 6. Moderate to large or ascites, as described in the protocol 7. Bowel obstruction within last 3 months or current need for parenteral nutrition NOTE: Other protocol-defined inclusion/exclusion criteria apply

Primary outcome measure(s)

Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 by investigator assessment — Up to 3 years

Trial sites (56)

Facility	City	Region	Status
The University of Alabama at Birmingham	Birmingham	Alabama	Recruiting
UC San Diego Health	La Jolla	California	Recruiting
Cedars Sinai Medical Center	Los Angeles	California	Recruiting
Mayo Clinic Jacksonville	Jacksonville	Florida	Recruiting
University of Miami Sylvester Comprehensive Cancer Center	Miami	Florida	Recruiting
Advent Health Cancer Institute	Orlando	Florida	Recruiting
Tampa General Hospital Cancer Institute	Tampa	Florida	Recruiting
University of Chicago	Chicago	Illinois	Recruiting
The University of Kansas Cancer Center	Westwood	Kansas	Recruiting
Norton Cancer Institute, St. Matthews Clinic	Louisville	Kentucky	Recruiting
Massachusetts General Hospital	Boston	Massachusetts	Recruiting
Karmanos Cancer Institute	Detroit	Michigan	Recruiting
The Ohio State University Comprehensive Cancer Center	Hilliard	Ohio	Recruiting
Providence Cancer Institute	Portland	Oregon	Recruiting
University of Pittsburgh Medical Center, Magee-Womens Hospital	Pittsburgh	Pennsylvania	Recruiting
West Penn Hospital of Allegheny Health Network	Pittsburgh	Pennsylvania	Recruiting
Avera Cancer Institute Sioux Falls	Sioux Falls	South Dakota	Recruiting
UT Southwestern Medical Center	Dallas	Texas	Recruiting
Swedish Cancer Institute	Seattle	Washington	Recruiting
University of Wisconsin	Madison	Wisconsin	Recruiting
Medical College of Wisconsin	Milwaukee	Wisconsin	Recruiting
CancerCare Manitoba	Winnipeg	Manitoba	Recruiting
Princess Margaret Cancer Centre	Toronto	Ontario	Recruiting
Centre de Santé et de Services Sociaux de la Montérégie-Centre	Greenfield Park	Quebec	Recruiting
Jewish General Hospital	Montreal	Quebec	Recruiting
Research Institute - McGill University Health Centre	Montreal	Quebec	Recruiting
Centre Hospitalier Universitaire (CHU) de Quebec - Universite Laval	Québec	Canada	Recruiting
National Cancer Center	Gyeonggi-do	Gyeonggi-do	Recruiting
Seoul National University Bundang Hospital	Seongnam-si	Gyeonggi-do	Recruiting
Gachon University Gil Medical Center	Incheon	Seoul	Recruiting
Keimyung University Dongsan Hospital	Daegu	South Korea	Recruiting
Severance Hospital Yonsei University Health System	Seoul	South Korea	Recruiting
Asan Medical Center, Univ. of Ulsan	Seoul	South Korea	Recruiting
Samsung Medical Center	Seoul	South Korea	Recruiting
Gangnam Severance Hospital	Seoul	South Korea	Recruiting
Seoul National University Hospital	Seoul	South Korea	Recruiting
Korea University Guro Hospital	Seoul	South Korea	Recruiting
Changhua Christian Hospital	Changhua	Changhua City	Recruiting
Chi Mei Medical Center	Tainan	Taiwan	Recruiting
Mackay Memorial Hospital	Taipei	Taiwan	Recruiting

+ 16 more sites — see the full list on the official registry below.

On this site

📄 Avastin (bevacizumab) drug profile → 📄 Libtayo (cemiplimab) drug profile → 📄 Kevzara (sarilumab) drug profile →

More Regeneron Pharmaceuticals trials in the USA

An Observational Retrospective Cohort Study Being Conducted in Women With Atopic Dermatitis (AD) Recruiting

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Efficacy and Safety of Mibavademab in Adult and Pediatric Patients With Generalized Lipodystrophy Recruiting

Adult Outpatient Linvoseltamab With Tocilizumab Prophylaxis to Mitigate the Risk of Cytokine Release Syndrome (CRS) Recruiting

A Study to Find Out How Safe REGN5668 is and How Well it Works In Adult Women When Given With Either Cemiplimab, or Cemiplimab + Fianlimab, or Ubamatamab Recruiting

Other trials for the same condition

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 Recruiting

A Study Evaluating the Efficacy and Safety of Biomarker-Driven Therapies in Patients With Persistent or Recurrent Rare Epithelial Ovarian Tumors Active, not recruiting

A Study to Assess Adverse Events, Change in Disease Activity and How Intravenous (IV) ABBV901 Moves Through the Body Alone or in Combination With Bevacizumab in Adult Participants With Ovarian Cancer Recruiting

CATALINA-2: A Clinical Study of TORL-1-23 in Platinum-resistant Ovarian Cancer. Recruiting

A Study to Find Out How Safe REGN5668 is and How Well it Works In Adult Women When Given With Either Cemiplimab, or Cemiplimab + Fianlimab, or Ubamatamab Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06787612 on ClinicalTrials.gov ↗ ← All trials in the USA