NCT07545811 Study of JANX014 in Subjects With Metastatic Castration-Resistant Prostate Cancer
| NCT ID | NCT07545811 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Janux Therapeutics |
| Condition | Prostate Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 43 participants |
| Start Date | 2026-04-15 |
| Primary Completion | 2028-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 43 participants in total. It began in 2026-04-15 with a primary completion date of 2028-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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).
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07545811 clinical trial?
This trial is open to male participants only, aged 18 Years or older, studying Prostate Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07545811 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07545811 currently recruiting?
Yes, NCT07545811 is actively recruiting participants. Contact the research team at PRCA-014-001_ct.gov@januxrx.com for enrollment information.
Where is the NCT07545811 trial being conducted?
This trial is being conducted at Nashville, United States.
Who is sponsoring the NCT07545811 clinical trial?
NCT07545811 is sponsored by Janux Therapeutics. The trial plans to enroll 43 participants.
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