A Trial to Find Out if REGN5678 (Nezastomig) is Safe and How Well it Works Alone or in Combination With Cemiplimab for Adult Participants With Metastatic Castration-Resistant Prostate Cancer and Other Tumors

The main purpose of this study is to determine the safety, tolerability (how the body reacts to the drug\[s\]) and effectiveness (ability to treat the cancer) of REGN5678 (Nezastomig) alone, or in combination with cemiplimab. The study has 2 parts. The goal of Part 1 (dose escalation) is to determine a safe dose(s) of REGN5678 when it is given alone or in combination with cemiplimab. The goal of Part 2 (dose expansion) is to use the REGN5678 drug dose(s) found in Part 1 to see how well REGN5678 alone or in combination with cemiplimab works to shrink tumors. This study is looking at several o

Trial Details

NCT ID
NCT03972657
Phase
PHASE1 / PHASE2
Sponsor
Regeneron Pharmaceuticals
Status
RECRUITING
Cancer Type
Kidney Cancer
Interventions
  • REGN5678
  • Cemiplimab
Locations (sample)
  • Gilbert, Arizona, United States|33.35283,-111.78903
  • Phoenix, Arizona, United States|33.44838,-112.07404
  • Tucson, Arizona, United States|32.22174,-110.92648
  • Santa Monica, California, United States|34.01949,-118.49138
  • Denver, Colorado, United States|39.73915,-104.9847

Key Eligibility Criteria

  • mCRPC cohorts (men):
  • Men with histologically or cytologically confirmed adenocarcinoma of the prostate without pure small cell carcinoma.
  • PSA value at screening ≥4 ng/mL that has progressed within 6 months prior to screening as defined in the protocol.
  • Has received ≥2 lines prior systemic therapy approved in the metastatic and/or castration-resistant setting (in addition to Androgen Deprivation Th…

For full eligibility, visit ClinicalTrials.gov.

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