Study on Ubamatamab Combination Therapy for Adults with Platinum-Resistant Ovarian Cancer
Sponsor: Regeneron Pharmaceuticals
ClinicalTrials ID:NCT06787612
This clinical trial is testing a new drug called ubamatamab, alone and in combination with other cancer treatments, to see if it is safe and effective for patients with advanced ovarian cancer that has not responded to platinum-based treatments.
Patient Parameters
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Program Overview
The purpose of this study is to evaluate the safety, tolerability, and effectiveness of an experimental drug called ubamatamab in patients with advanced ovarian cancer. The study will test ubamatamab both on its own and in combination with other cancer drugs, including bevacizumab, cemiplimab, fianlimab, and a chemotherapy drug called pegylated liposomal doxorubicin (PLD). Researchers will also look at potential side effects, how the drug is processed in the body, and whether the body develops antibodies against it, which could affect its effectiveness or cause side effects.
Eligibility Criteria
Inclusion Criteria
- Have a confirmed diagnosis of advanced serous or endometrioid ovarian, primary peritoneal, or fallopian tube cancer (excluding clear cell, mucinous, and carcinosarcoma types).
- Cancer must have progressed after previous treatment and have at least one measurable tumor that has not been treated with radiation.
- Be in good overall health with an ECOG performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
- Have adequate organ and bone marrow function as specified in the study protocol.
- Have ovarian cancer that is resistant to platinum-based treatments, as defined in the study protocol.
Exclusion Criteria
- Have had major surgery or a significant injury within four weeks before starting the study treatment.
- Have a known allergy or severe reaction to antibody treatments or doxorubicin hydrochloride, or any components of the study drugs.
- Have another type of cancer that is progressing or requires treatment, as specified in the study protocol.
- Have untreated or active brain tumors, cancer spread to the central nervous system, or spinal cord compression, as specified in the study protocol.
- Have uncontrolled infections, including HIV, hepatitis B or C, or a diagnosis of immunodeficiency.
Note: Additional criteria may apply as defined in the study protocol.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| The University of Alabama at Birmingham | 35233 | Birmingham | Alabama |
| Cedars Sinai Medical Center | 90048 | Los Angeles | California |
| Mayo Clinic Jacksonville | 32224 | Jacksonville | Florida |
| University of Miami Sylvester Comprehensive Cancer Center | 33136 | Miami | Florida |
| Tampa General Hospital Cancer Institute | 33606 | Tampa | Florida |
| The University of Kansas Cancer Center | 66205 | Westwood | Kansas |
| Norton Cancer Institute, St. Matthews Clinic | 40207 | Louisville | Kentucky |
| Massachusetts General Hospital | 02114 | Boston | Massachusetts |
| Karmanos Cancer Institute | 48201 | Detroit | Michigan |
| The Ohio State University Comprehensive Cancer Center | 43026 | Hilliard | Ohio |
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