OncoMatch/Clinical Trials/NCT06970119
A Multicenter, Open-label, Non-randomized Phase I/IIa Clinical Trial to Evaluate INR102 Injection in Patients With Prostate Cancer
Is NCT06970119 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies INR102 for prostate cancer.
Treatment: INR102 — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Prostate Cancer
Biomarker criteria
Required: FOLH1 positive result on 18F-PSMA-137 PET/CT scan
A positive result on the 18F-PSMA-137 PET/CT scan is required.
Disease stage
Metastatic disease required
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: androgen receptor pathway inhibitor (enzalutamide, apalutamide, abiraterone)
Subjects who have previously failed treatment with at least one novel androgen receptor pathway inhibitor (e.g., enzalutamide, apalutamide, and/or abiraterone)
Must have received: taxane
and taxane-based therapies are eligible
Cannot have received: radioisotope therapy
Within six months prior to the first study treatment, subjects had received systemic or local radioisotope therapy
Cannot have received: PSMA-targeted therapy
Subjects who have undergone any prior treatment targeting PSMA are ineligible for participation in the study
Cannot have received: systemic anti-tumor treatments
Exception: 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
Cannot have received: external beam radiotherapy
Exception: palliative radiotherapy
subjects received external beam radiotherapy, with the exception of palliative radiotherapy
Cannot have received: traditional Chinese medicine therapies with anti-tumor indications
subjects had received traditional Chinese medicine therapies with anti-tumor indications
Cannot have received: blood transfusion therapy
Within 28 days prior to the first study treatment, subjects must not have received blood transfusion therapy
Lab requirements
Blood counts
Absolute neutrophil count ≥1.5×10^9/L, platelet count ≥100×10^9/L, hemoglobin level ≥90g/L; no supportive treatments (blood transfusions or G-CSF) within 14 days prior to screening
Kidney function
Serum creatinine ≤1.5×ULN or CrCl ≥60 mL/min (Cockcroft-Gault); serum albumin ≥3g/dL
Liver function
Total bilirubin ≤1.5× ULN, ALT and AST ≤3×ULN; in cases of liver metastasis, ALT and AST ≤5×ULN
Subjects must demonstrate adequate organ function as follows: Bone marrow reserve: Absolute neutrophil count ≥1.5×10^9/L, platelet count ≥100×10^9/L, hemoglobin level ≥90g/L. No relevant supportive treatments, including blood product transfusions or granulocyte colony-stimulating factor (G-CSF), should have been administered within 14 days prior to the screening period examination. Liver function: Total bilirubin ≤1.5× upper limit of normal (ULN), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3×ULN. In cases of liver metastasis, ALT and AST levels ≤5×ULN are acceptable. Kidney function: Serum creatinine ≤1.5×ULN or creatinine clearance rate (CrCl) ≥60 mL/min (calculated using the Cockcroft-Gault formula). Serum albumin must be ≥3g/dL.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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