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Also known as ubletamig
REGN5668 · 1 trial · 4 indications
Dose escalation phase, Module 1
Dose escalation phase, Module 2
Primary: Dose escalation phase Secondary: Dose expansion phase
Primary: Dose escalation phase Secondary: Dose expansion phase
Primary: Dose escalation phase Secondary: Dose expansion phase
Primary: Dose escalation phase Secondary: Dose expansion phase
Primary: Dose escalation phase
Primary: Dose expansion phase
| Arm | Type | Description |
|---|---|---|
| Module 1 | EXPERIMENTAL | REGN5668 in combination with cemiplimab, or cemiplimab + fianlimab |
| Module 2 | EXPERIMENTAL | REGN5668 and ubamatamab |
| Name | Type | Description |
|---|---|---|
| REGN5668 | DRUG | Administer per the protocol |
| Cemiplimab | DRUG | Administer per the protocol |
| Ubamatamab | DRUG | Administer per the protocol |
| Sarilumab | DRUG | Administer per the protocol |
| Cemiplimab + Fianlimab [Fixed Dose Combination (FDC)] | DRUG | Administer per the protocol |
Key Inclusion Criteria: 1. Ovarian Cancer Cohorts Only: Has histologically or cytologically confirmed diagnosis of advanced epithelial ovarian cancer (except carcinosarcoma), primary peritoneal, or fallopian tube cancer that has received at least 1 line of platinum-based systemic therapy as defined...
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REGN5668 is an investigational small molecule being studied for the treatment of ovarian cancer. The Phase 1 trial also enrolls patients with fallopian tube cancer, primary peritoneal cancer, and endometrial cancer. It is not yet approved for any indication and remains in clinical development.
REGN5668 targets MUC16, a protein expressed on the surface of ovarian cancer cells. By binding MUC16, the drug is designed to act against tumors that express this target. The trial is biomarker selected, meaning patients are enrolled based on characteristics related to the target.
REGN5668 is being developed by Regeneron Pharmaceuticals, Inc., which trades on the Nasdaq under the ticker REGN. Regeneron is the sponsor of the clinical program evaluating the drug in gynecologic cancers, including ovarian cancer.
REGN5668 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA or any other regulatory agency. The single registered trial is currently recruiting participants and has not yet been completed.
REGN5668 is being evaluated in the Phase 1 trial NCT04590326, titled a study of how safe REGN5668 is and how well it works in adult women when given with either cemiplimab, or cemiplimab plus fianlimab, or ubamatamab. The trial is recruiting, plans to enroll 612 participants, and is open in the United States, Belgium, Brazil, France, and Spain.
The REGN5668 Phase 1 trial NCT04590326 enrolls adult women aged 18 years and older. It is not open to healthy volunteers. Participants must have ovarian cancer, fallopian tube cancer, primary peritoneal cancer, or endometrial cancer, and the study is biomarker selected.