Recruiting
Phase 1

JANX013 & JANX007

Sponsor:

Janux Therapeutics

Code:

NCT07813637

Conditions

Prostate Cancer

Castration-Resistant Prostate Cancer (CRPC)

Metastatic Prostate Cancer

Metastatic Castration-Resistant Prostate Cancer Patients

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

JANX013

JANX007

JANX013

JANX007

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 JANX013 in combination with JANX007 in adults with metastatic castration-resistant prostate cancer (mCRPC).

Conditions

Prostate Cancer

Castration-Resistant Prostate Cancer (CRPC)

Metastatic Prostate Cancer

Metastatic Castration-Resistant Prostate Cancer Patients

Study ID

NCT07813637

Start date

Sep 10, 2026

Status verified date

Sep, 2026

Completion date

Jul, 2030

Anticipated

Primary completion date

Jul, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

110 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

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

Primary outcome measure

  • Incidence of adverse events (AEs), serious adverse events (SAEs), and dose-limiting toxicities (DLTs) [ Time Frame: 2 years ]
  • Incidence of cytokine release syndrome (CRS) [ Time Frame: 2 years ]

Central Contacts and Locations

Central contacts

Locations

Sarah Cannon Research Institute

Recruiting

Nashville, Tennessee, United States, 37203

More Information

Sponsor

Janux Therapeutics

Last update posted

Sep 17, 2026

Last verified

Sep, 2026

Keywords

  • mCRPC
  • Metastatic Castration-Resistant Prostate Cancer
  • PSMA
  • Prostate-Specific Membrane Antigen
  • CD3 T cell engager
  • T cell engager
  • Bispecific antibody
  • Immunotherapy
  • Prostate cancer metastatic

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-18. This information was provided to ClinicalTrials.gov by Janux Therapeutics on 2026-09-17.