Phase 1 Trial to Study JANX013 and JANX007 Combination in mCRPC
Part of paid clinical trials in Nashville, Tennessee.
- Sponsor
- Janux Therapeutics
- Study ID
- NCT07813637
- Phase
- PHASE1
- Status
- Recruiting
Conditions
- Castration-Resistant Prostate Cancer (CRPC)
- Metastatic Castration-Resistant Prostate Cancer Patients
- Metastatic Prostate Cancer
- Prostate Cancer
Eligibility Criteria
- Sex
- MALE
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
Study Details
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).
Key Dates
- First listed
- Sep 10, 2026
- Start date
- Sep 10, 2026
- Status verified
- Sep 2026
- Primary completion
- Jul 31, 2029
- Completion
- Jul 31, 2030
Study Design
- Enrollment
- 110 participants (estimated)
- Allocation
- NON_RANDOMIZED
- Intervention model
- SEQUENTIAL
- Primary purpose
- TREATMENT
Arms
- Experimental: Dose EscalationParticipants receive JANX013 in combination with JANX007 administered at increasing dose levels per cohort
- Experimental: Dose ExpansionParticipants receive JANX013 in combination with JANX007. Participants will be dosed at levels previously declared tolerable.
Primary Outcome Measure
Incidence of adverse events (AEs), serious adverse events (SAEs), and dose-limiting toxicities (DLTs) [ Time Frame: 2 years ]
Central Contacts
- Janux Therapeutics, MD1-858-206-8471
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Sarah Cannon Research Institute | Nashville | Tennessee | 37203 | - |
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