Phase 1 Trial to Study JANX013 and JANX007 Combination in mCRPC
Recruiting · NCT07813637 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
JANX007JANX013
What this trial is about
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 JANX013 in combination with JANX007 in adults with metastatic castration-resistant prostate cancer (mCRPC).
Who can take part
Age range
18 Years and older
Sex
Male
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 1
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Male participants ≥ 18 years of age at the time of signing informed consent
- Histologically or cytologically confirmed adenocarcinoma of the prostate
- For Dose Escalation:
- \- Have received at least 1 novel ARPI (e.g., abiraterone acetate, enzalutamide, apalutamide, or darolutamide) in any setting and have received at least 1 taxane regimen (in any setting), or who are medically unsuitable or have actively refused treatment with a taxane regimen.
- For Dose Expansion:
- Must be in the first-line or second-line setting for mCRPC or metastatic androgen pathway modulation resistant disease and must have received 1 novel ARPI in any setting.
- Adequate organ function
- Key
Exclusion criteria
- Prior treatment with any chimeric antigen receptor (CAR) T-cell therapy, any approved or investigational TCE, or any T-cell costimulatory agent
- Clinically significant cardiovascular disease
- Prior solid organ transplant
Where it is running
1 location listed across 1 US state.
- Sarah Cannon Research Institute - Nashville, Tennessee, United States