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OncoMatch/Clinical Trials/NCT05519449

Study of JANX007 in Subjects With Metastatic Castration-Resistant Prostate Cancer (ENGAGER-PSMA-01)

Is NCT05519449 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including JANX007 and Darolutamide for prostate cancer.

Phase 1RecruitingJanux TherapeuticsNCT05519449Data as of May 2026

Treatment: JANX007 · Darolutamide — This study is a first-in-human, Phase 1, open-label, multicenter study to assess the safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD), and the preliminary efficacy of JANX007 in adults with metastatic castration-resistant prostate cancer (mCRPC).

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Extracted eligibility criteria

Cancer type

Prostate Cancer

Disease stage

Metastatic disease required

Prior therapy

Must have received: antiandrogen — HSPC or CRPC

progressed after at least one novel anti-androgen therapy

Must have received: taxane

at least one taxane containing regimen. Participants who have actively refused a taxane containing regimen or are medically unsuitable to receive taxane are eligible

Cannot have received: PSMA-targeted CAR-T cell therapy

Prior treatment with PSMA-targeted CAR-T cell therapy

Cannot have received: PSMA-CD3 bispecific antibody

Prior treatment with PSMA-CD3, PSMA-CD28 or other CD3 T-cell engaging bispecific antibodies

Cannot have received: radioligand therapy

Prior treatment with ... radioligand therapy

Lab requirements

Blood counts

Kidney function

Liver function

Adequate organ function

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • University of Alabama at Birmingham Hospital · Birmingham, Alabama
  • Mayo Clinic · Phoenix, Arizona
  • USC Norris Comprehensive Cancer Center · Los Angeles, California
  • UCLA Department of Medicine · Los Angeles, California
  • Hoag Memorial Hospital Presbyterian · Newport Beach, California

Showing up to 5 US sites. See all sites on ClinicalTrials.gov →

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