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NCT07813637PHASE1Recruiting

Phase 1 Trial to Study JANX013 and JANX007 Combination in mCRPC

Janux Therapeutics

Start Date

9/10/2026

Completion Date

7/1/2030

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 JANX013 in combination with JANX007 in adults with metastatic castration-resistant prostate cancer (mCRPC).

Eligibility Criteria

Age Range: 18 years to No maximum

Key Inclusion Criteria: * Male participants ≥ 18 years of age at the time of signing informed consent * Histologically or cytologically confirmed adenocarcinoma of the prostate For Dose Escalation: \- Have received at least 1 novel ARPI (e.g., abiraterone acetate, enzalutamide, apalutamide, or darolutamide) in any setting and have received at least 1 taxane regimen (in any setting), or who are medically unsuitable or have actively refused treatment with a taxane regimen. For Dose Expansion: * Must be in the first-line or second-line setting for mCRPC or metastatic androgen pathway modulation resistant disease and must have received 1 novel ARPI in any setting. * Adequate organ function Key Exclusion Criteria: * Prior treatment with any chimeric antigen receptor (CAR) T-cell therapy, any approved or investigational TCE, or any T-cell costimulatory agent * Clinically significant cardiovascular disease * Prior solid organ transplant

Interventions

DRUG

JANX013

DRUG

JANX007

DRUG

JANX013

DRUG

JANX007

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Conditions

Prostate CancerCastration-Resistant Prostate Cancer (CRPC)Metastatic Prostate CancerMetastatic Castration-Resistant Prostate Cancer Patients

Locations

Sarah Cannon Research Institute

Nashville, Tennessee 37203

United States