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Clinical Trials in the USA / NCT07813637
Recruiting Phase 1

Phase 1 Trial to Study JANX013 and JANX007 Combination in mCRPC

NCT07813637 · tracked via the Priya Life Science USA tracker
Sponsor
Janux Therapeutics
Phase
Phase 1
Started
2026-09-10
Last updated
2026-09-17

Condition(s) studied

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

Investigational drug(s) / intervention(s)

JANX013JANX007 →JANX013JANX007 →

JANX013: JANX013 will be administered via IV dosing.

JANX007: JANX007 will be administered via IV dosing.

JANX013: JANX013 will be administered via IV dosing

JANX007: JANX007 will be administered via IV dosing

Study 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

Sex
MALE
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Incidence of adverse events (AEs), serious adverse events (SAEs), and dose-limiting toxicities (DLTs) — 2 years
  • Incidence of cytokine release syndrome (CRS) — 2 years
    Cytokine release syndrome (CRS) assessed according to ASTCT criteria.

Trial sites (1)

FacilityCityRegionStatus
Sarah Cannon Research Institute Nashville Tennessee Recruiting

More Janux Therapeutics trials in the USA

Study of JANX007 in Subjects With Metastatic Castration-Resistant Prostate Cancer (ENGAGER-PSMA-01) Recruiting
Study of JANX014 in Subjects With Metastatic Castration-Resistant Prostate Cancer Recruiting
Study of JANX008 in Subjects With Advanced or Metastatic Solid Tumor Malignancies Active, not recruiting

Other trials for the same condition

A Study of Metastases Free Survival With Saruparib vs Placebo Added to a Standard RT/ADT in Men With High-risk Prostate Cancer With a BRCA Mutation Recruiting
A Randomised Controlled Trial to Evaluate the Impact of Complement Theory's Live CoActive Exercise Coaching and Personalized Digital Application on Cancer Survivors' Quality of Life Active, not recruiting
A Phase 1-2 Study of ST101 in Patients With Advanced Solid Tumors Active, not recruiting
Stratagen Quantitative Prostate MRI Platform Pilot Study Active, not recruiting
dMD-002 Pilot Study in Patients With Cavernous Nerve Injury Following Radical Prostatectomy Starting soon
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07813637 on ClinicalTrials.gov ↗ ← All trials in the USA