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

Launched by REGENERON PHARMACEUTICALS · Jan 16, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called ubamatamab for women with a type of ovarian cancer that has not responded to standard treatments. The researchers want to find out how safe and effective ubamatamab is on its own, as well as when combined with other cancer drugs. They will also look into any side effects that might occur and how the body reacts to the drug over time.

To participate in this study, women must have a confirmed diagnosis of advanced ovarian cancer that has not improved with previous treatments. They should have measurable tumors that can be tracked during the study and be in good overall health. Participants can expect to receive careful monitoring and support throughout the trial as researchers assess the effects of the treatment. It’s important to note that this study is not yet recruiting participants, so interested individuals will need to wait for it to begin.

Gender

FEMALE

Eligibility 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