This study will test an experimental Regeneron drug called REGN21353 ("study drug") to see if it can help treat previously treated prostate cancer that has spread (also called metastatic castration-resistant prostate cancer or mCRPC). Some participants may get additional experimental drugs in combination with REGN21353. These additional drugs are nezastomig and sarilumab. "Experimental" means that the drugs are being tested and have not been approved for use in prostate cancer by a country's national health agency that gives approval for new medicines to be prescribed.
The study is looking at:
* What is the best dose of REGN21353 alone and together with nezastomig for treating prostate cancer * What side effects REGN21353 alone and together with nezastomig might cause * How well REGN21353 alone and together with nezastomig works * How much REGN21353 alone and together with nezastomig is in the blood at different times * If the body reacts to REGN21353 alone or together with nezastomig, in a way that may cause them to not work as well * How REGN21353 alone and together with nezastomig could affect prostate cancer, which can help researchers understand why REGN21353 alone or together with nezastomig work better in some than others
Is male with histologically or cytologically confirmed adenocarcinoma of the prostate without pure small cell carcinoma
Has metastatic castration-resistant prostate cancer with prostate-specific antigen value as described in the protocol and that has progressed within 6 months prior to screening
Has received ≥2 lines of prior systemic therapy approved in the metastatic and/or castration-resistant setting (in addition to androgen deprivation therapy) including at least one androgen receptor pathway inhibitor (eg, abiraterone, enzalutamide, apalutamide, or darolutamide)
Has had either orchiectomy or be on luteinizing hormone-releasing hormone (LHRH) agonist or antagonist therapy with serum testosterone levels as described in the protocol and agree to stay on LHRH agonist or antagonist therapy during the trial
Has not recovered (ie, grade ≤1 or baseline) from immune-mediated adverse event within 3 months prior to initiation of trial intervention therapy except for endocrinopathies adequately managed with hormone replacement
Has permanently discontinued anti-cancer immune modulating therapies due to immune-mediated adverse events
Has another malignancy that is progressing or requires active treatment, except non-melanoma skin cancer that has undergone potentially curative therapy or any tumor that has been deemed to be effectively treated with definitive local control
Has ongoing or recent (within 5 years) evidence of significant autoimmune disease (including any history of systemic vasculitis) that required treatment with systemic immunosuppressive treatments
Sequential
REGN21353
DrugAdministered per the protocol
Nezastomig
DrugAdministered per the protocol
Sarilumab Prophylaxis (Contingency)
DrugMay be administered as pretreatment, per the protocol
Occurrence of Treatment Emergent Adverse Events (TEAEs)
Dose escalation
Occurrence of Dose-Limiting Toxicities (DLTs)
Dose escalation
Occurrence of Serious Adverse Events (SAEs)
Dose escalation
Occurrence of Adverse Events of Special Interests (AESIs)
Dose escalation
(CRR) of ≥50% decline of prostate specific antigen (PSA) and/or confirmed radiographic response of complete response (CR) or partial response (PR)
Dose escalation
Occurrence of TEAEs
Dose expansion
Occurrence of SAEs
Dose expansion
Occurrence of AESIs
Dose expansion
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This trial is not recruiting at the moment. You can still explore other options:
