Overview
This study employed an open-label, non-randomized design, representing the first human trial of its kind. It utilized a standard 3+3 dose-escalation approach, focusing on patients with metastatic castration-resistant prostate cancer, initiating treatment at a dose of 1.85 GBq over a 6-week period. Subsequent cohorts underwent sequential 50% dose escalations until the observation of dose-limiting toxicity (DLT).
Description
[177Lu]Lu-LNC1011 is a novel long-circulating PSMA therapeutic probe. This study represents the first human investigation, aiming to explore its maximum tolerated dose (MTD), safety, dosimetry, and initial treatment efficacy in patients with metastatic castration-resistant prostate cancer (mCRPC).This study employed an open-label, non-randomized design, representing the first human trial of its kind. It utilized a standard 3+3 dose-escalation approach, focusing on patients with metastatic castration-resistant prostate cancer, initiating treatment at a dose of 1.85 GBq over a 6-week period. Subsequent cohorts underwent sequential 50% dose escalations until the observation of dose-limiting toxicity (DLT).
Eligibility
Inclusion Criteria:
- progressive metastatic castration-resistant prostate cancer
- tumors with high PSMA expression confirmed on 68Ga-PSMA PET/CT PSMA expression confirmed on 68Ga-PSMA PET/CT
Exclusion Criteria:
- a serum creatinine level of more than 150 μmol per liter
- a hemoglobin level of less than 10.0 g/dl
- a white-cell count of less than 4.0× 109/L
- a platelet count of less than 100 × 109/L
- a total bilirubin level of more than 3 times the upper limit of the normal range
- a serum albumin level of more than 3.0 g per deciliter
- cardiac insufficiency