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

Regeneron Pharmaceuticals

Status and phase: Not yet enrolling; Phase 2

Conditions: Ovarian Cancer

Treatments: Drug: Bevacizumab; Drug: Sarilumab; Drug: Cemiplimab; Drug: Fianlimab; Drug: PLD; Drug: Ubamatamab

Study type: Interventional

Funder types: Industry

Identifiers

NCT06787612

R4018-ONC-2445

2024-517806-27-00 (Registry Identifier)

Details and patient eligibility

About

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

Enrollment: 220 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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220 participants in 5 patient groups

Arm A1

Experimental group

Description:

Randomization as described in the protocol

Treatment:

Drug: Ubamatamab

Drug: Sarilumab

Arm A2

Experimental group

Description:

Randomization as described in the protocol

Treatment:

Drug: Ubamatamab

Drug: Sarilumab

Arm B

Experimental group

Description:

Randomization as described in the protocol

Treatment:

Drug: Ubamatamab

Drug: Sarilumab

Drug: Bevacizumab

Arm C

Experimental group

Description:

Randomization as described in the protocol

Treatment:

Drug: Ubamatamab

Drug: Fianlimab

Drug: Cemiplimab

Drug: Sarilumab

Arm D

Experimental group

Description:

Randomization as described in the protocol

Treatment:

Drug: PLD

Drug: Ubamatamab

Drug: Sarilumab