Phase 1 Trial to Study JANX013 and JANX007 Combination in mCRPC
A Phase 1 Open-Label, Multicenter Study of JANX013 Combined With JANX007 in Participants With Metastatic Castration Resistant Prostate Cancer
About This Trial
- This clinical trial is testing a new combination of two experimental drugs to find a safe dose and see how well they work against prostate cancer.
- It is for adult men with advanced prostate cancer that has spread to other areas of the body and continues to grow despite standard hormone therapy.
- To be eligible, patients must have already received certain newer hormone-blocking medications, and some participants may need to have previously received chemotherapy.
- Because this is an early-stage study testing the drug combination in humans for the first time, doctors are primarily watching for side effects, so the treatment's benefits are not yet proven.
- Patients with serious heart problems, prior organ transplants, or a history of specific immune-based cancer therapies cannot take part.
More Information
- 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).
Who Can Enroll
- Age Range: 18 years and older
- Gender: Male
- Who This Trial is For: This clinical trial is testing a new combination of two experimental drugs to find a safe dose and see how well they work against prostate cancer.
Study Details
- Start Date: September 10, 2026
- Lead Sponsor: Janux Therapeutics
Full Eligibility Criteria
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
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
Treatments
- Drug: JANX013
- Drug: JANX007