Title
Multi-Arm Phase 2 Study of Ubamatamab (Regn4018; Muc16×Cd3 Bispecific Antibody) With or Without Additional Agents in Platinum -Resistant Ovarian Cancer

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

Objective
Primary:
1. To assess the ORR of ubamatamab alone or in combination with bevacizumab, cemiplimab + fianlimab, or PLD (separately by study arm).

Secondary:
1. To assess preliminary efficacy of ubamatamab or combinations as measured by changes to CA-125 response, CR rate, DCR, DOR, and PFS.
2. Evaluate the ability of sarilumab to mitigate Grade less than or equal to 2 CRS
3. To assess the safety of ubamatamab monotherapy and ubamatamab combinations including safety with sarilumab
4. To assess the immunogenicity of ubamatamab, fianlimab, and other experimental agents, as applicable
5. To assess PK of combination therapy

Treatment 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

Key Eligibility Key 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

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

Applicable Disease Sites
Ovary

Participating Institutions
UW Health Eastpark Medical Center; UW Health University Hospital