A PHASE 1/2 STUDY OF REGN5678 (ANTI-PSMAXCD28) WITH OR WITHOUT CEMIPLIMAB (ANTI-PD-1) IN PATIENTS WITH METASTATIC CASTRATION-RESISTANT PROSTATE CANCER AND OTHER TUMORS ASSOCIATED WITH PSMA EXPRESSION

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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