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Recruiting
NCT07813637
Phase 1 Trial to Study JANX013 and JANX007 Combination in mCRPC
Conditions: Prostate Cancer, Castration-Resistant Prostate Cancer (CRPC), Metastatic Prostate Cancer, Metastatic Castration-Resistant Prostate Cancer Patients
Sex: Male
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE1
Enrollment: 110
Sponsor: Janux Therapeutics
Location: Sarah Cannon Research Institute Nashville Tennessee
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 JANX013 in combination with JANX007 in adults with metastatic castration-resistant prostate cancer (mCRPC).
Eligibility Criteria
Key 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
Source: ClinicalTrials.gov (NCT07813637). StuddyBuddy aggregates publicly available trial information.