Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
REGN5678 · 1 trial · 2 indications
Dose Escalation Phase
Dose Escalation Phase
Dose Escalation Phase
Dose Escalation Phase
Dose Escalation Phase
Dose Escalation Phase
Dose Escalation Phase
Dose Expansion Phase - mCRPC cohort
Dose Expansion Phase - ccRCC cohort
| Arm | Type | Description |
|---|---|---|
| mCRPC - dose escalation cohort | EXPERIMENTAL | REGN5678 with or without cemiplimab |
| mCRPC - dose expansion cohort | EXPERIMENTAL | REGN5678 with or without cemiplimab |
| ccRCC - dose escalation cohort | EXPERIMENTAL | REGN5678 with or without cemiplimab |
| ccRCC - dose expansion cohort | EXPERIMENTAL | REGN5678 with or without cemiplimab |
| Name | Type | Description |
|---|---|---|
| REGN5678 | DRUG | Administered as per the protocol |
| Cemiplimab | DRUG | Administered as per the protocol |
Key Inclusion Criteria: mCRPC cohorts (men): 1. Men with histologically or cytologically confirmed adenocarcinoma of the prostate without pure small cell carcinoma. 2. PSA value at screening ≥4 ng/mL that has progressed within 6 months prior to screening as defined in the protocol. 3. Has received...
REGN5678 is an investigational small molecule being studied for the treatment of metastatic castration-resistant prostate cancer (mCRPC). It is also being evaluated in clear cell renal cell carcinoma (ccRCC) as part of a clinical trial. The drug is currently in Phase 1 development and has not been approved by regulatory authorities.
REGN5678 targets PSMA, a protein that is highly expressed on prostate cancer cells. By binding to PSMA, the drug is designed to deliver a therapeutic effect specifically to cancer cells. This targeted approach is being investigated in patients with metastatic castration-resistant prostate cancer.
REGN5678 is being developed by Regeneron Pharmaceuticals, Inc., a biopharmaceutical company traded on the Nasdaq under the ticker symbol REGN. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational drug in patients with certain advanced cancers.
REGN5678 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by the FDA or any other regulatory agency. The ongoing Phase 1 trial is recruiting participants to assess the drug's safety, tolerability, and preliminary activity in metastatic castration-resistant prostate cancer and other tumors.
REGN5678 is being studied in a Phase 1 clinical trial with the identifier NCT03972657. This trial is evaluating the drug alone or in combination with cemiplimab in adult participants with metastatic castration-resistant prostate cancer and other tumors. The study is recruiting up to 345 participants in the United States.
Yes, REGN5678 is also known as Nezastomig. The clinical trial NCT03972657 refers to the drug as REGN5678 (Nezastomig). Both names refer to the same investigational small molecule being developed by Regeneron Pharmaceuticals for the treatment of certain advanced cancers.