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

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
Male
Accepts 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

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Sequential Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Dose Escalation 		JANX014 will be administered at increasing dose levels per cohort to determine the maximum tolerated dose.
  • Biological: JANX014
    JANX014 will be administered via IV dosing
Experimental
Dose Expansion 		Participants will be dosed at levels previously declared tolerable.
  • Biological: JANX014
    JANX014 will be administered via IV dosing

Recruiting Locations

Washington University School of Medicine
St Louis, Missouri 63108

Prisma Health Cancer Institute
Greenville, South Carolina 29605

SCRI Oncology Partners
Nashville, Tennessee 37203

SCRI at Mary Crowley
Dallas, Texas 75230

More Details

Status
Recruiting
Sponsor
Janux Therapeutics

Study Contact

Janux Therapeutics, MD
+1 858-206-8471
PRCA-014-001_ct.gov@januxrx.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.