Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
REGN10597 · 1 trial · 3 indications
Dose escalation
Dose escalation
Dose escalation
Dose escalation
Dose escalation
Dose escalation Grade 3 or higher per Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Dose expansion
| Arm | Type | Description |
|---|---|---|
| Phase 1: Monotherapy Dose Escalation | EXPERIMENTAL | Multiple Dose Level (DL) Cohorts to identify the Recommended Phase 2 Dose (RP2D) |
| Phase 2: Monotherapy Dose Expansion | EXPERIMENTAL | Cohort 1: Melanoma participants Cohort 2: Clear-cell Renal-Cell Carcinoma (ccRCC) participants |
| Phase 1: Combination Dose Escalation | EXPERIMENTAL | Multiple DL Cohorts to identify the RP2D |
| Phase 2: Combination Dose Expansion | EXPERIMENTAL | Cohort 1: Melanoma participants |
| Name | Type | Description |
|---|---|---|
| REGN10597 | DRUG | Administered per the protocol |
| Cemiplimab | DRUG | Administered per the protocol |
Key Inclusion Criteria: Dose escalation cohorts: 1\. Histologically or cytologically confirmed diagnosis of solid malignancy (locally advanced or metastatic) with confirmed progression on standard-of-care therapy. Participants are required to submit archival tissue if it is available Dose expansi...
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REGN10597 is an investigational small molecule being developed for the treatment of melanoma. It is also being studied in clear-cell renal-cell carcinoma (ccRCC) and advanced solid tumors. The drug is intended for adult participants whose tumors have spread in their body.
REGN10597 is being developed by Regeneron Pharmaceuticals, Inc., a biopharmaceutical company traded on the Nasdaq under the ticker symbol REGN. The company is currently conducting a first-in-human study of the drug in the United States.
REGN10597 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. The ongoing Phase 1 trial is recruiting participants to evaluate the drug alone or in combination with cemiplimab.
REGN10597 is being studied in a single Phase 1 clinical trial with the identifier NCT06413680. This first-in-human study is recruiting 240 adult participants in the United States with melanoma, clear-cell renal-cell carcinoma, or advanced solid tumors. The trial is not randomized or double-blinded.
REGN10597 is a small molecule therapeutic being investigated for its anti-cancer activity. The specific molecular target of REGN10597 has not been disclosed in the available clinical trial information. The drug is being studied alone and in combination with cemiplimab, an immunotherapy agent.