Phase 1 Trial to Study JANX013 and JANX007 Combination in mCRPC

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

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

Conditions5

Interventions2

Locations1 site

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• Study of JANX007 in Subjects With Metastatic Castration-Resistant Prostate Cancer (ENGAGER-PSMA-01) — Janux Therapeutics

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