Join us at Health Research Day — June 6th at Canton Waterfront Park, Baltimore!   Learn More →
← Back to all trials
Recruiting NCT07545811

Study of JANX014 in Subjects With Metastatic Castration-Resistant Prostate Cancer

Conditions: Prostate Cancer, Metastatic Castration-resistant Prostate Cancer, Castration-resistant Prostate Cancer

Sex: Male
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE1
Enrollment: 43
Sponsor: Janux Therapeutics

Location: Washington University School of Medicine St Louis Missouri

Summary

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 JANX014 in adults with metastatic castration-resistant prostate cancer (mCRPC).

Eligibility Criteria

Inclusion Criteria: * Male ≥18 years of age at the time of signing informed consent * Histologically or cytologically confirmed adenocarcinoma of the prostate * For Dose Escalation: Having mCRPC that progressed after at least one novel anti-androgen therapy and at least one taxane containing regimen. Participants who have actively refused a taxane containing regimen or are medically unsuitable to receive taxane are eligible. * Adequate organ function * For Dose Expansion Part: Have received ≤ 2 anti-androgen therapies in either the HSPC or CRPC setting and no more than 1 prior taxane regimen in the HSPC setting. Participants who have actively refused a taxane regimen or are medically unsuitable to receive taxane are eligible. Exclusion Criteria: * Prior solid organ transplant * Prior treatment with any CAR-T cell therapy, approved or investigational T-cell engager therapy, and prior receipt of radioligand therapy * Clinically significant cardiovascular disease

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07545811). StuddyBuddy aggregates publicly available trial information.