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Study of JANX007 for Metastatic Castration-Resistant Prostate Cancer

This study is testing a new treatment called JANX007 for men with metastatic castration-resistant prostate cancer (mCRPC), which is prostate cancer that has spread and no longer responds to hormone therapy. JANX007 is given through an IV, sometimes along with darolutamide, an oral tablet. The main goals are to see how safe JANX007 is and what side effects it might cause over three years. Researchers are also looking at how the body handles JANX007 and if it shows any early signs of helping. You might be able to join if you are a man aged 18 to 100 with prostate cancer that has progressed after certain prior treatments. The study is currently recruiting about 272 participants, but its overall status is unclear.

Study design
This is a Phase 1, open-label study, meaning both you and your doctors will know which treatment you are receiving. It is a first-in-human study, focusing on safety and early effectiveness.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for side effects for up to 3 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05519449

Study of JANX007 in Subjects With Metastatic Castration-Resistant Prostate Cancer (ENGAGER-PSMA-01)

Recruiting
PHASE1Ages 18+InterventionalTreatment
Janux Therapeutics
~272 participants
Updated 2026-08-13 on ClinicalTrials.gov
What's tested:JANX007Darolutamide

At a glance

Recruiting sites
36 of 36 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of Dose Limiting Toxicities (DLT)
Measured over 3 years
+1 more outcome measured

Conditions

Prostate Cancer
Metastatic Castration-resistant Prostate Cancer
Castration Resistant Prostatic Cancer

Explore related trials

Prostate Carcinoma

Where it's being run

36 sites across 20 states
New York6
California5
Pennsylvania3
Texas3
Minnesota2
Ohio2
Wisconsin2
Alabama1

Study leadership

  • Janux Therapeutics, MD · STUDY_DIRECTOR · Janux Therapeutics

Who to contact

Janux Therapeutics
[email protected]
858-206-8471
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Incidence of Dose Limiting Toxicities (DLT)3 years
  • Incidence of Adverse Events (AE) and Serious Adverse Events (SAE)3 years