Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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. It is also being evaluated in related conditions including fallopian tube cancer, primary peritoneal cancer, and endometrial cancer. The drug is currently in Phase 1 clinical development and is not yet approved by regulatory authorities.
REGN5668 targets MUC16, a protein that is often overexpressed in ovarian cancer cells. By binding to MUC16, the drug is designed to interfere with tumor growth. This mechanism is being investigated in a Phase 1 clinical trial to assess its safety and efficacy in adult women with certain gynecologic cancers.
REGN5668 is being developed by Regeneron Pharmaceuticals, Inc., a biopharmaceutical company traded on the Nasdaq under the ticker symbol REGN. The company is conducting clinical research to evaluate the drug's safety and effectiveness in treating ovarian cancer and related gynecologic malignancies.
REGN5668 is currently in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by the FDA or other regulatory agencies. The ongoing Phase 1 trial is recruiting participants to evaluate the drug's safety, tolerability, and preliminary efficacy in adult women with ovarian cancer and other specified conditions.
REGN5668 is being studied in a single Phase 1 clinical trial registered as NCT04590326. This open-label, controlled study is recruiting 612 adult women with ovarian cancer, fallopian tube cancer, primary peritoneal cancer, or endometrial cancer. The trial is being conducted in the United States, Belgium, Brazil, France, and Spain.
Yes, REGN5668 is being studied in combination with other investigational therapies. The Phase 1 trial NCT04590326 evaluates REGN5668 when given with either cemiplimab, cemiplimab plus fianlimab, or ubamatamab. The study aims to determine the safety and effectiveness of these combination regimens in adult women with certain gynecologic cancers.