This study is researching a new drug called REGN15505 when used alone or in combination with cemiplimab or in combination with REGN4336 in adult patients with mCRPC and ccRCC. The goal is to explore new ways to treat these cancers by helping immune cells target and destroy cancer cells.
The study will evaluate the use of REGN15505 when administered alone, in combination with cemiplimab, or in combination with REGN4336 for:
* Any side effects of study drugs * How well the study drugs work * How much REGN15505, cemiplimab, and REGN4336 are in the blood at different times * If the body makes antibodies to REGN15505 or REGN4336, which may mean the study drugs will not work as well as expected * What is the best dose of REGN15505 when administered alone and with cemiplimab and the best dose of REGN15505 and REGN4336 when used in combination
Men with histologically or cytologically confirmed adenocarcinoma of the prostate without pure small cell carcinoma
mCRPC with PSA value at screening ≥4 ng/mL and that has progressed within 6 months prior to screening as described in the protocol
Has received ≥2 lines of prior systemic therapy approved in the metastatic and/or castration-resistant setting as described in the protocol
Have had either Orchiectomy or be on Luteinizing Hormone-Releasing Hormone (LHRH) agonist or antagonist therapy with serum testosterone <50 ng/dL AND agree to stay on LHRH agonist or antagonist therapy during the study
Has received treatment with an approved systemic therapy (including sipuleucel-T for mCRPC patients) within 3 weeks of dosing or has not yet recovered (ie, grade ≤1 or baseline) from any acute toxicities except for laboratory changes as described in the protocol
Has received prior Prostate Specific Membrane Antigen (PSMA)-targeting therapy with the exception of a PSMA-targeting radioligand (eg, 177Lu-PSMA-617)
Sequential
REGN15505
DrugAdministered per protocol
REGN15505+Cemiplimab
DrugAdministered per protocol
REGN15505+REGN4336
DrugAdministered per protocol
Occurrence of Dose Limiting Toxicities (DLTs)
Dose Escalation
Occurrence of Treatment-Emergent Adverse Events (TEAEs)
Dose Escalation
Occurrence of Serious Adverse Events (SAEs)
Dose Escalation
Occurrence of Adverse Events of Special Interest (AESIs)
Dose Escalation
Occurrence of TEAEs
Dose Expansion
Occurrence of SAEs
Dose Expansion
Occurrence of AESIs
Dose Expansion
CompR based on ≥50% decline of PSA from baseline and/or confirmed radiographic assessment of CR or PR
Dose Escalation-mCRPC
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