Testing JANX007 for advanced prostate cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a first-in-human, Phase 1, open-label, multicenter study designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of JANX007 in adults diagnosed with metastatic castration-resistant prostate cancer (mCRPC). Participants will receive JANX007 and Darolutamide, with the study focusing on those who have previously undergone specific anti-androgen and taxane therapies. The trial aims to gather essential data on how well the treatment works and its effects on patients.

Why it matters

Who can join: the full rules

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 and Backfill: 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 Monotherapy Expansion Part a: Have received ≤ 2 anti-androgen therapies in either the HSPC or CRPC setting and no more than 1 prior taxane regimen in the HSPC or CRPC setting. Participants who have actively refused a taxane regimen or are medically unsuitable to receive taxane are eligible.
* For Monotherapy Expansion Part b: Have received ≤ 2 anti-androgen therapies in either the HSPC or CRPC settings
* For Monotherapy Expansion Part d: Have received ≤ 1 anti-androgen therapy and a poly(ADP-ribose) polymerase (PARP) inhibitor for mCRPC and have progressed following treatment with the PARP inhibitor
* For Combination Expansion: Have received ≤ 1 anti-androgen therapy other than darolutamide in the HSPC setting and ≤ 1 taxane in the mCRPC 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 PSMA-targeted CAR-T cell therapy or PSMA-CD3, PSMA-CD28 or other CD3 T-cell engaging bispecific antibodies or radioligand therapy
* Clinically significant cardiovascular disease
* For Monotherapy Expansion Part a: Prior receipt of any treatment other than an ARPI or taxane in the mCRPC setting
* For Monotherapy Expansion Part b: Prior receipt of any treatment other than an anti-androgen therapy or prior receipt of a taxane containing regimen or more than 1 prior line of therapy for mCRPC
* For Monotherapy Part d: More than 1 prior line of therapy for mCRPC or prior receipt of any treatment other than an anti-androgen therapy and PARP inhibitor for mCRPC or prior receipt of a taxane in the mCRPC setting
* For Combination expansion: More than 1 prior line of therapy for mCRPC or prior receipt of any treatment other than a taxane for mCRPC or prior receipt of Darolutamide or prior receipt of a taxane for HSPC
* Active clinically significant infection (bacterial, viral, fungal, mycobacteria or other)
* Any medical condition or clinical laboratory abnormality likely to interfere with assessment of safety or efficacy of study treatment

Where it's running

• University of Alabama at Birmingham Hospital
  Birmingham, Alabama, United States Recruiting
• Mayo Clinic
  Phoenix, Arizona, United States Recruiting
• USC Norris Comprehensive Cancer Center
  Los Angeles, California, United States Recruiting
• UCLA Department of Medicine
  Los Angeles, California, United States Recruiting
• Hoag Memorial Hospital Presbyterian
  Newport Beach, California, United States Recruiting
• University of California Davis Comprehensive Cancer Center
  Sacramento, California, United States Recruiting

Study contacts

• Study coordinator: Janux Therapeutics
• Email: psma-007-001_ct.gov@januxrx.com
• Phone: 858-206-8471

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.