Phase 1 Trial to Study JANX013 and JANX007 Combination in mCRPC

Purpose

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

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
Male
Accepts Healthy Volunteers
No

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

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

Phase
Phase 1
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Sequential Assignment
Intervention Model Description
Participants are assigned to sequential cohorts in a dose-escalation phase followed by dose-expansion cohorts evaluating the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of JANX013 in combination with JANX007 in participants with metastatic castration-resistant prostate cancer.
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Dose Escalation 		Participants receive JANX013 in combination with JANX007 administered at increasing dose levels per cohort
  • Drug: JANX013
    JANX013 will be administered via IV dosing.
  • Drug: JANX007
    JANX007 will be administered via IV dosing.
Experimental
Dose Expansion 		Participants receive JANX013 in combination with JANX007. Participants will be dosed at levels previously declared tolerable.
  • Drug: JANX013
    JANX013 will be administered via IV dosing
  • Drug: JANX007
    JANX007 will be administered via IV dosing

Recruiting Locations

Sarah Cannon Research Institute
Nashville, Tennessee 37203

More Details

Status
Recruiting
Sponsor
Janux Therapeutics

Study Contact

Janux Therapeutics, MD
1-858-206-8471
PSMA-013-001_ct.gov@januxrx.com