Recruiting
Phase 1

JANX014

Sponsor:

Janux Therapeutics

Code:

NCT07545811

Conditions

Prostate Cancer

Metastatic Castration-resistant Prostate Cancer

Castration-resistant Prostate Cancer

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

JANX014

Study Details

Brief 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).

Conditions

Prostate Cancer

Metastatic Castration-resistant Prostate Cancer

Castration-resistant Prostate Cancer

Study ID

NCT07545811

Start date

Apr 15, 2026

Status verified date

Aug, 2026

Completion date

Mar, 2029

Anticipated

Primary completion date

May, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

43 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Dose Escalation

JANX014 will be administered at increasing dose levels per cohort to determine the maximum tolerated dose.

experimental: Dose Expansion

Participants will be dosed at levels previously declared tolerable.

Interventions

JANX014

JANX014 will be administered via IV dosing

Primary outcome measure

  • Incidence of Dose Limiting Toxicities (DLTs) [ Time Frame: 2 years ]
  • Incidence of adverse events (AE) and Serious Adverse Events (SAE) [ Time Frame: 2 years ]

Central Contacts and Locations

Central contacts

Janux Therapeutics, MD

+1 858-206-8471PRCA-014-001_ct.gov@januxrx.com

Locations

UC San Diego Moores Cancer Center

Recruiting

La Jolla, California, United States, 92037

Washington University School of Medicine

Recruiting

St Louis, Missouri, United States, 63108

Medical University of South Carolina - Hollings Cancer Center

Recruiting

Charleston, South Carolina, United States, 29425

Prisma Health Cancer Institute

Recruiting

Greenville, South Carolina, United States, 29605

SCRI Oncology Partners

Recruiting

Nashville, Tennessee, United States, 37203

SCRI at Mary Crowley

Recruiting

Dallas, Texas, United States, 75230

More Information

Sponsor

Janux Therapeutics

Last update posted

Sep 3, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Janux Therapeutics on 2026-09-03.