Multi-arm Phase 2 Study of Ubamatamab (REGN4018; MUC16×CD3 Bispecific Antibody) with or without Additional Agents in Platinum-Resistant Ovarian Cancer

Cancer Categories

Karmanos Trial ID

NCT ID

Age Group

Scope

Phase

Principal Investigator

Ira
Winer, M.D., Ph.D., FACOG
Oncology - Gynecologic, Oncology - Surgical View Profile

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

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

4100 John R
Detroit, MI 48201
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Phone: 1-800-527-6266

31995 Northwestern Hwy
Farmington Hills, MI 48334
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Phone: 1-800-527-6266

Applicable Disease Site

Therapies, Drugs, Devices