A Multicenter, Open-label, Non-randomized Phase I/IIa Clinical Trial to Evaluate INR102 In
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.
| Condition(s) | Prostate Cancer |
|---|---|
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Study type | Interventional |
| 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. |
| Who can participate | Inclusion Criteria: * Willingly participate in this clinical trial, demonstrate a clear understanding of the research procedures, and be capable of signing the informed consent form in person. * Be at least 18 years of age at the time of signing the informed consent form. * Histologically or cytologically confirmed prostate cancer (excluding neuroendocrine or small cell features). * A positive result on the 18F-PSMA-137 PET/CT scan is required. * The serum testosterone levels of the subjects must be maintained at a castrate level (\< 50 ng/dL or \< 1.7 nmol/L). Despite maintaining castrate-level serum testosterone, disease progression was confirmed based on at least one of the following criteria: Progression in PSA was defined as an increase in serum PSA measured twice, one week apart, wit |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Yunhe Pharmaceutical (Tianjin) Co., Ltd |
| Locations | Wuxi, Jiangsu, China; Tianjin, Tianjin Municipality, China |
| Start date | 2025-05-14 |
| NCT ID | NCT06970119 |
| Official listing | https://clinicaltrials.gov/study/NCT06970119 |