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.
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.
Within six months prior to the first study treatment, subjects had received systemic or local radioisotope therapy. Subjects who have undergone any prior treatment targeting PSMA are ineligible for participation in the study.
Within 28 days before the first study treatment or within five half-lives of the agent (whichever is shorter), subjects received systemic anti-tumor treatments, including chemotherapy, immunotherapy, small molecule inhibitors, or cell therapy. Within 28 days before the first study treatment, subjects received external beam radiotherapy, with the exception of palliative radiotherapy. Within two weeks before the first study treatment, subjects had received traditional Chinese medicine therapies with anti-tumor indications.
Subjects who have experienced Grade 4 myelosuppression following prior anti-tumor therapy, or Grade 3 myelosuppression requiring more than six weeks for recovery, or who have received external radiotherapy targeting extensive bone marrow (> 25%) in the past are ineligible. Within 28 days prior to the first study treatment, subjects must not have received blood transfusion therapy. -
The subjects' prior anti-tumor treatment toxicity had not resolved to CTCAE grade ≤1 (NCI CTCAE v5.0), with the exception of alopecia (all grades permitted) and peripheral neuropathy (requiring recovery to grade ≤2).
Single group
INR102 injection
DrugINR102 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.
Validity Index
The proportion of subjects whose PSA decreased by ≥50% relative to the baseline and was confirmed by the second (next) PSA measurement after 4 weeks.
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