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NCT06787612 | NOT YET RECRUITING | Ovarian Cancer

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

Regeneron Pharmaceuticals

Brief Summary:

This study is researching an experimental drug called ubamatamab, also referred to as "study drug". The study is focused on patients 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 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

Condition or disease

Ovarian Cancer

Intervention/treatment

Ubamatamab

Bevacizumab

Cemiplimab

Fianlimab

PLD

Sarilumab

Phase

PHASE2

Study Type : INTERVENTIONAL
Estimated Enrollment : 220 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : Multi-arm Phase 2 Study of Ubamatamab (REGN4018; MUC16×CD3 Bispecific Antibody) With or Without Additional Agents in Platinum-Resistant Ovarian Cancer
Actual Study Start Date : 2025-05-01
Estimated Primary Completion Date : 2028-04-30
Estimated Study Completion Date : 2028-04-30

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers:
Criteria
Key Inclusion Criteria
  • 1. Participants with histologically or cytologically confirmed diagnosis of advanced serous or endometrioid ovarian, 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 drug(s)
    • 2. Documented allergic or acute hypersensitivity reaction attributed to antibody treatments or doxorubicin hydrochloride or components of study drug(s)
    • 3. Another malignancy that is progressing or requires active treatment, as described in the protocol
    • 4. Untreated or active primary brain tumor, Central Nervous System (CNS) metastases, or spinal cord compression, 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
    • NOTE: Other protocol-defined inclusion/exclusion criteria apply
Investigation of Ubamatamab Combination Therapy in Adult Participants With Platinum-Resistant Ovarian Cancer

Location Details

NCT06787612

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