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

NCT06787612
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Phase
Phase 2
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Recruitment status
Recruiting
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Participants
297
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Lead sponsor
Regeneron Pharmaceuticals
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Start date
2025-05-28
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Number of sites
55
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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
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Short title
Investigation of Ubamatamab Combination Therapy in Adult Participants With Platinum-Resistant Ovarian Cancer
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Official title
Multi-Arm Phase 2 Platform Study of Ubamatamab (REGN4018; MUC16×CD3 Bispecific Antibody) With or Without Additional Agents in Platinum-Resistant Ovarian Cancer
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Control arm
Open label
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Recruiting
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Phase
Phase 2
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Study type
Interventional
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Completion date
2028-06-30
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First posted
2025-01-22
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Registry last updated
2026-08-12
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Primary completion date
2028-06-30
clinicaltrials.gov
Start date
2025-05-28
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Participants
297
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Participant count basis
Estimated
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Planned participants
297
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Protocol amendments
2
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Number of sites
55
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Data monitoring committee
No
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Registry sponsor category
Industry
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Lead sponsor
Regeneron Pharmaceuticals
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Source registry
ClinicalTrials.gov
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Registry ID
NCT06787612
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ClinicalTrials.gov ID
NCT06787612
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
No masking
Sources for study design
clinicaltrials.gov

  1. Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 by investigator assessment

    Timeframe: Up to 3 years

  1. Cancer Antigen (CA) -125 response by Gynecologic Cancer Intergroup (GCIG) Criteria

    Timeframe: Up to 3 years

  2. Complete Response (CR) rate by RECIST 1.1

    Timeframe: Up to 3 years

  3. Disease Control Rate (DCR) by RECIST 1.1

    Timeframe: Up to 3 years

  4. Duration of Response (DOR) by RECIST 1.1

    Timeframe: Up to 3 years

  5. Progression-Free Survival (PFS) by RECIST 1.1

    Timeframe: Up to 3 years

  6. Occurrence of Grade ≥ 2 Cytokine Release Syndrome (CRS) by Lee criteria

    Timeframe: Up to 3 years

  7. Treatment-Emergent Adverse Events (TEAEs) by Common Terminology Criteria for Adverse Events (CTCAE) v5.0

    Timeframe: Up to 3 years

  8. TEAEs by Lee criteria

    Timeframe: Up to 3 years

  9. Concentration of ubamatamab in serum

    Timeframe: Up to 3 years

  10. Concentration of fianlimab in serum

    Timeframe: Up to 3 years

  11. Concentration of REGN10597 in serum

    Timeframe: Up to 3 years

  12. Occurrence of Anti-Drug Antibodies (ADA) to ubamatamab

    Timeframe: Up to 3 years

  13. Magnitude of ADA to ubamatamab

    Timeframe: Up to 3 years

  14. Occurrence of ADA to fianlimab

    Timeframe: Up to 3 years

  15. Magnitude of ADA to fianlimab

    Timeframe: Up to 3 years

  16. Occurrence of ADA to cemiplimab

    Timeframe: Up to 3 years

  17. Magnitude of ADA to cemiplimab

    Timeframe: Up to 3 years

  18. Occurrence of ADA to REGN10597

    Timeframe: Up to 3 years

  19. Magnitude of ADA to REGN10597

    Timeframe: Up to 3 years

Sources for outcomes
clinicaltrials.gov

Sex
Female
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

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

Sources for eligibility
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  • The University of Alabama at BirminghamBirmingham, United StatesRecruiting
  • UC San Diego HealthLa Jolla, United StatesRecruiting
  • Cedars Sinai Medical CenterLos Angeles, United StatesRecruiting
  • Mayo Clinic JacksonvilleJacksonville, United StatesRecruiting
  • University of Miami Sylvester Comprehensive Cancer CenterMiami, United StatesRecruiting
  • Advent Health Cancer InstituteOrlando, United StatesRecruiting
  • Tampa General Hospital Cancer InstituteTampa, United StatesRecruiting
  • University of ChicagoChicago, United StatesRecruiting
  • The University of Kansas Cancer CenterWestwood, United StatesRecruiting
  • Norton Cancer Institute, St. Matthews ClinicLouisville, United StatesRecruiting
  • Massachusetts General HospitalBoston, United StatesRecruiting
  • Karmanos Cancer InstituteDetroit, United StatesRecruiting
  • The Ohio State University Comprehensive Cancer CenterHilliard, United StatesRecruiting
  • Providence Cancer InstitutePortland, United StatesRecruiting
  • University of Pittsburgh Medical Center, Magee-Womens HospitalPittsburgh, United StatesRecruiting
  • West Penn Hospital of Allegheny Health NetworkPittsburgh, United StatesRecruiting
  • Avera Cancer Institute Sioux FallsSioux Falls, United StatesRecruiting
  • UT Southwestern Medical CenterDallas, United StatesRecruiting
  • Swedish Cancer InstituteSeattle, United StatesRecruiting
  • University of WisconsinMadison, United StatesRecruiting
  • Medical College of WisconsinMilwaukee, United StatesRecruiting
  • CancerCare ManitobaWinnipeg, CanadaRecruiting
  • Princess Margaret Cancer CentreToronto, CanadaRecruiting
  • Centre de Santé et de Services Sociaux de la Montérégie-CentreGreenfield Park, CanadaRecruiting
  • Jewish General HospitalMontreal, CanadaRecruiting

And 30 more, listed on the interactive page.

Sources for sites
clinicaltrials.gov

Other registry identifiers

  • 2024-517806-27-00
Sources for references
clinicaltrials.gov

Related records

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Lead sponsors (1)

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