Approval Probability
TA Base Rate
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REGN21353 · 1 trial · 2 indications
Dose escalation
Dose escalation
Dose escalation
Dose escalation
Dose expansion
| Arm | Type | Description |
|---|---|---|
| Module 1: monotherapy | EXPERIMENTAL | - |
| Module 2: combination | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| REGN21353 | DRUG | Administered per the protocol |
| Nezastomig | DRUG | Administered per the protocol |
| Sarilumab Prophylaxis (Contingency) | DRUG | May be administered as pretreatment, per the protocol |
Key Inclusion Criteria: 1. Is male with histologically or cytologically confirmed adenocarcinoma of the prostate without pure small cell carcinoma 2. Has metastatic castration-resistant prostate cancer with prostate-specific antigen value as described in the protocol and that has progressed within ...
REGN21353 is an investigational small molecule being developed by Regeneron Pharmaceuticals for metastatic castration-resistant prostate cancer, often abbreviated mCRPC. It is in Phase 1 clinical development and is not yet approved for any indication. It is being studied both as a single agent and in combination with another drug, nezastomig.
REGN21353 is being evaluated for the treatment of metastatic castration-resistant prostate cancer, or mCRPC, in adult male patients. It is an investigational therapy and has not been approved for this or any other use. The ongoing study enrolls men aged 18 years and older with this condition.
REGN21353 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 compound in metastatic castration-resistant prostate cancer.
REGN21353 is in Phase 1 clinical development. It is an investigational small molecule and is not FDA approved. The single registered trial is a Phase 1 study that has not yet begun recruiting participants.
REGN21353 is being studied in one registered clinical trial, NCT07850921, titled REGN21353 Alone or in Combination With Nezastomig for Metastatic Castration-Resistant Prostate Cancer in Adult Participants. The Phase 1 trial is not yet recruiting and plans to enroll 192 male participants aged 18 years and older.
Yes. The Phase 1 trial NCT07850921 evaluates REGN21353 both as a single agent and in combination with nezastomig in adults with metastatic castration-resistant prostate cancer. The study is controlled, is not randomized, and is not double blinded, and it plans to enroll 192 participants.