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

  • JANX013 — DRUG
    JANX013 will be administered via IV dosing.
  • JANX007 — DRUG
    JANX007 will be administered via IV dosing.
  • JANX013 — DRUG
    JANX013 will be administered via IV dosing
  • JANX007 — DRUG
    JANX007 will be administered via IV dosing

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 Escalation
    Participants receive JANX013 in combination with JANX007 administered at increasing dose levels per cohort
  • Experimental: Dose Expansion
    Participants 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

Locations (1)

FacilityCityStateZIPSite coordinators
Sarah Cannon Research InstituteNashvilleTennessee37203-

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