A PHASE 1/2 STUDY OF REGN5678 (ANTI-PSMAXCD28) WITH CEMIPLIMAB (ANTI-PD-1) IN PATIENTS WITH METASTATIC CASTRATION-RESISTANT PROSTATE CANCER [Regeneron 5678-ONC-1879]

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    Prostate Cancer
  • Age: Between 18 Year(s) - 100 Year(s)
  • Gender: Male
  • Other Inclusion Criteria:
    1) Histologically or cytologically confirmed adenocarcinoma of the prostate without pure small cell carcinoma. 2) Metastatic, castration-resistant prostate cancer (mCRPC) with PSA value at screening =4 ng/mL that has progressed within 6 months prior to screening as defined in the protocol. 3) Adequate organ and bone marrow function.

You may not be eligible for this study if the following are true:

  • 1) Has received treatment with an approved systemic therapy within 3 weeks of dosing or has not yet recovered (ie, grade =1 or baseline) from any acute toxicities. 2) Has received any previous systemic biologic therapy within 5 half-lives of first dose of study therapy and has received prior PSMA-targeting therapy. 3) Dose Expansion Only: Has had prior anti-cancer immunotherapy - Any condition that requires ongoing/continuous corticosteroid therapy (>10 mg prednisone/day or anti-inflammatory equivalent) within 1 week prior to the first dose of study therapy.


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