Language: BG BG
← Back to results
Recruiting Phase 1 NCT07545811

Study of JANX014 in Subjects With Metastatic Castration-Resistant Prostate Cancer

Phase 1 – testing safety in a small group of people
Conditions: Prostate Cancer Metastatic Castration-resistant Prostate Cancer Castration-resistant Prostate Cancer

Sponsor: Janux Therapeutics

trial.available_in: БГ
Overview
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).
Who can participate
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
Interventions
JANX014
BIOLOGICAL
Locations 1
United States (1)
Research Site
Nashville , Tennessee
Technical details
Status
Recruiting
Phase
Phase 1
Study type
INTERVENTIONAL
Sex
Male only
Minimum age
18 Years
Healthy volunteers
No
Start date
15.04.2026
Completion date
01.03.2029
Registry ID
NCT07545811
Source
clinicaltrials.gov
trial.inquiry_btn

Information is automatically extracted from ClinicalTrials.gov. Consult your doctor before taking action.