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Multi-arm Phase 2 Study of Ubamatamab (REGN4018; MUC16×CD3 Bispecific Antibody) with or without Additional Agents in Platinum-Resistant Ovarian Cancer
Cancer Categories
Gastrointestinal (GI),Gynecologic
Karmanos Trial ID
2025-044
NCT ID
NCT06787612
Age Group
Adult
Scope
National
Phase
Phase II
Includes controlled clinical studies conducted to evaluate the effectiveness of the drug for a particular indication or indications in participants with the disease or condition under study and to determine the common short-term side effects and risks.
Phase II
Principal Investigator
Ira
Winer, M.D., Ph.D., FACOG
Oncology - Gynecologic, Oncology - Surgical
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Objective:
Primary Objectives:
Efficacy
To assess the Objective Response Rate (ORR) of ubamatamab alone or in combination with bevacizumab, cemiplimab + fianlimab, or PLD (separately by study arm)
Secondary Objectives:
Efficacy
To assess preliminary efficacy of ubamatamab combinations as measured by changes to CA-125 response, CR rate, disease control rate (DCR), duration of response (DOR), and progression-free survival (PFS).
Evaluate the ability of sarilumab to mitigate Grade ≥2 CRS
Safety
To assess the safety of ubamatamab monotherapy, and ubamatamab combinations including safety with sarilumab
To assess pharmacokinetics (PK) of ubamatamab, and fianlimab in combination therapy
To assess the immunogenicity of ubamatamab, fianlimab, and other experimental agents, as applicable
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NCI Dictionary of Cancer Terms
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Eligibility
Locations
Applicable Disease Site
Therapies | Drugs | Devices
Eligibility
Eligibility
Inclusion Criteria:
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)
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
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Adequate organ and bone marrow function, as described in the protocol
Platinum-Resistant Ovarian Cancer, as described in the protocol
Exclusion Criteria:
Major surgical procedure or significant traumatic injury within 4 weeks prior to first dose of study drug(s)
Documented allergic or acute hypersensitivity reaction attributed to antibody treatments or doxorubicin hydrochloride or components of study drug(s)
Another malignancy that is progressing or requires active treatment, as described in the protocol
Untreated or active primary brain tumor, Central Nervous System (CNS) metastases, or spinal cord compression, as described in the protocol
Uncontrolled infections including but not limited to human immunodeficiency virus, hepatitis B or hepatitis C infection, or diagnosis of immunodeficiency
Locations
Locations
Karmanos Cancer Institute - Detroit Headquarters
4100 John R
Detroit, MI 48201
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Phone:
1-800-527-6266
Karmanos Cancer Institute at Weisberg Cancer Center - Farmington Hills
31995 Northwestern Hwy
Farmington Hills, MI 48334
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Phone:
1-800-527-6266
Applicable Disease Site
Applicable Disease Site
Liver; Ovary; Stomach
Therapies, Drugs, Devices
Therapies | Drugs | Devices
Therapies
Biological Therapy, Immunotherapy
Drugs
Bevacizumab; Cemiplimab; Fianlimab; Pegylated Liposomal Doxorubicin; Sarilumab; Ubamatamab
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