JANX014 for metastatic castration-resistant prostate cancer
A Phase 1 Open-Label, Multicenter Study of JANX014 in Participants With Prostate Cancer
This trial will test whether JANX014 is safe, how your body handles it, and whether it shows signs of benefit in adults with metastatic castration-resistant prostate cancer who have already had anti-androgen therapy and typically a taxane.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 43 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Janux Therapeutics Industry-sponsored |
| Drugs / interventions | CAR-T |
| Locations | 1 site (Nashville, Tennessee) |
| Trial ID | NCT07545811 on ClinicalTrials.gov |
What this trial studies
This first-in-human, open-label Phase 1 study gives JANX014 to adults with metastatic castration-resistant prostate cancer to define safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary signs of anti-tumor activity. The study uses a dose-escalation phase to identify a tolerable dose and a dose-expansion phase to further characterize safety and early efficacy signals. Eligible participants generally must have progressed after at least one novel anti-androgen and typically a prior taxane regimen, although those who refused or cannot receive taxane may qualify. The trial excludes patients with prior CAR-T or T-cell engager therapy, prior radioligand therapy, prior solid organ transplant, or significant cardiovascular disease and is conducted at a research site in Nashville, Tennessee.
Who should consider this trial
Good fit: Men aged 18 or older with histologically confirmed metastatic castration-resistant prostate cancer who progressed after at least one novel anti-androgen and typically one taxane regimen (or who refused/are ineligible for taxane) with adequate organ function are the intended candidates.
Not a fit: Patients with prior CAR-T or approved/investigational T-cell engager therapy, prior radioligand therapy, prior solid organ transplant, or clinically significant cardiovascular disease are excluded and therefore unlikely to benefit from participating.
Why it matters
Potential benefit: If successful, JANX014 could offer a new treatment option that slows disease progression for some men with advanced castration-resistant prostate cancer who have limited options.
How similar studies have performed: This is a first-in-human trial of JANX014, and while other immune- or cell-based approaches in prostate cancer have shown limited early signals, there is no established precedent of a broadly effective immune cure in mCRPC.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Nashville, Tennessee
- Research Site — Nashville, Tennessee, United States (Recruiting)
Study contacts
- Study coordinator: Janux Therapeutics, MD
- Email: PRCA-014-001_ct.gov@januxrx.com
- Phone: +1 858-206-8471
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.