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

NCT07545811 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: PRCA-014-001
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Incidence of Dose Limiting Toxicities (DLTs)

  2 years

• Incidence of adverse events (AE) and Serious Adverse Events (SAE)

  2 years

Secondary Outcomes (7)

• Area under the curve from time 0 to t of JANX014 (AUC0-t)

  up to 2 years

• Maximum observed concentration of JANX014 (Cmax)

  up to 2 years

• Number of participants who develop anti-drug antibodies against JANX014

  up to 2 years

• Prostate Specific Antigen (PSA) response

  up to 2 years

• Overall Response Rate

  up to 2 years

Study Arms (2)

Dose Escalation

EXPERIMENTAL

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

Biological: JANX014

Dose Expansion

EXPERIMENTAL

Participants will be dosed at levels previously declared tolerable.

Biological: JANX014

Interventions

JANX014 BIOLOGICAL

JANX014 will be administered via IV dosing

Dose Escalation; Dose Expansion

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Janux Therapeutics: lead

Study Sites (1)

Research Site

Nashville, Tennessee, 37203, United States

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Central Study Contacts

Janux Therapeutics, MD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2026
• First Posted: April 22, 2026
• Study Start: April 15, 2026
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): March 1, 2029
• Last Updated: April 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)