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Clinical Trials in the USA / NCT07545811
Recruiting Phase 1

Study of JANX014 in Subjects With Metastatic Castration-Resistant Prostate Cancer

NCT07545811 · tracked via the Priya Life Science USA tracker
Sponsor
Janux Therapeutics
Phase
Phase 1
Started
2026-04-15
Last updated
2026-09-03

Condition(s) studied

Prostate CancerMetastatic Castration-resistant Prostate CancerCastration-resistant Prostate Cancer

Investigational drug(s) / intervention(s)

JANX014

JANX014: JANX014 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 JANX014 in adults with metastatic castration-resistant prostate cancer (mCRPC).

Eligibility

Sex
MALE
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: * Male ≥18 years of age at the time of signing informed consent * Histologically or cytologically confirmed adenocarcinoma of the prostate * For Dose Escalation: Having mCRPC that progressed after at least one novel anti-androgen therapy and at least one taxane containing regimen. Participants who have actively refused a taxane containing regimen or are medically unsuitable to receive taxane are eligible. * Adequate organ function * For Dose Expansion Part: Have received ≤ 2 anti-androgen therapies in either the HSPC or CRPC setting and no more than 1 prior taxane regimen in the HSPC setting. Participants who have actively refused a taxane regimen or are medically unsuitable to receive taxane are eligible. Exclusion Criteria: * Prior solid organ transplant * Prior treatment with any CAR-T cell therapy, approved or investigational T-cell engager therapy, and prior receipt of radioligand therapy * Clinically significant cardiovascular disease

Primary outcome measure(s)

Trial sites (6)

FacilityCityRegionStatus
UC San Diego Moores Cancer Center La Jolla California Recruiting
Washington University School of Medicine St Louis Missouri Recruiting
Medical University of South Carolina - Hollings Cancer Center Charleston South Carolina Recruiting
Prisma Health Cancer Institute Greenville South Carolina Recruiting
SCRI Oncology Partners Nashville Tennessee Recruiting
SCRI at Mary Crowley Dallas Texas Recruiting
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 NCT07545811 on ClinicalTrials.gov ↗ ← All trials in the USA