A Multicenter, Open-label, Non-randomized Phase I/IIa Clinical Trial to Evaluate INR102 Injection in Patients With Prostate Cancer

This is a Phase I/IIa, open-label, multicenter clinical trial designed to evaluate the safety, tolerability, pharmacokinetics (PK), radiation dosimetry, and preliminary efficacy of multiple fixed doses of INR102 in subjects with PSMA-positive metastatic castration-resistant prostate cancer (mCRPC) who have progressed after treatment with at least one novel androgen receptor pathway inhibitor (ARPI) and taxane-based therapies. Based on the collected data, including potential dose-limiting toxicities (DLTs), maximum tolerated dose (MTD), and therapeutic doses of similar products, the recommended Phase II dose (RP2D) was determined. Subsequently, a dose-expansion cohort study was conducted using RP2D to further assess the preliminary efficacy, safety, tolerability, PK profile, and radiation dosimetry characteristics of INR102 in the same patient population.