NCT06970119

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

A Multicenter, Open-label, Non-randomized Phase I/IIa Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, Radiation Dosimetry, and Preliminary Efficacy of INR102 Injection in Patients With Prostate-specific Membrane Antigen (PSMA)-Positive Metastatic Castration-resistant Prostate Cancer (mCRPC)

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 55 (estimated)
• Sponsor: Yunhe Pharmaceutical (Tianjin) Co., Ltd · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A Phase I/IIa clinical trial to evaluate the safety, tolerability, pharmacokinetics, radiation dosimetry, and preliminary efficacy of INR102 injection in patients with prostate cancer.

Detailed description

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.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DRUG	INR102 injection	INR102 injection is a lutetium-177 (\[177Lu\])-labeled radiopharmaceutical agent targeting prostate-specific membrane antigen (PSMA). It is clinically indicated for the treatment of patients with PSMA-positive prostate cancer.

Timeline

• Start date: 2025-05-14
• Primary completion: 2029-06-20
• Completion: 2029-10-22
• First posted: 2025-05-14
• Last updated: 2026-01-07

Locations

2 sites across 1 country: China