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Phase 1 Trial to Study JANX013 and JANX007 Combination in mCRPC
RecruitingPhase 1
A Phase 1 Open-Label, Multicenter Study of JANX013 Combined With JANX007 in Participants With Metastatic Castration Resistant Prostate Cancer
Who can join
Ages 18 and older · Men
Full eligibility criteria
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
About the study
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).
What is being tested
- JANX013 (drug)
- JANX007 (drug)
- JANX013 (drug)
- JANX007 (drug)
Sponsor: Janux Therapeutics · Participants: 110 · Started: Sep 10, 2026
Contact the study team
- Janux Therapeutics, MD · Phone: 1-858-206-8471
Official record on ClinicalTrials.gov — NCT07813637
Locations in the U.S.
| Tennessee | Sarah Cannon Research Institute, Nashville |
Conditions
From ClinicalTrials.gov, data retrieved Oct 2, 2026. Each study sets its own eligibility; the study team decides who can join.