Prostate CancerCastration-Resistant Prostate Cancer (CRPC)Metastatic Prostate CancerMetastatic Castration-Resistant Prostate Cancer Patients
Investigational drug(s) / intervention(s)
JANX013JANX007JANX013JANX007
JANX013: JANX013 will be administered via IV dosing.
JANX007: JANX007 will be administered via IV dosing.
JANX013: JANX013 will be administered via IV dosing
JANX007: JANX007 will be administered via IV dosing
Study 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
Sex
MALE
Min age
18 Years
Max age
—
Healthy volunteers
No
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
Primary outcome measure(s)
Incidence of adverse events (AEs), serious adverse events (SAEs), and dose-limiting toxicities (DLTs) — 2 years
Incidence of cytokine release syndrome (CRS) — 2 years Cytokine release syndrome (CRS) assessed according to ASTCT criteria.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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