177Lu-LNC1011 in Patients with Metastatic Castration-resistant Prostate Cancer

Chinese Academy of Medical Sciences & Peking Union Medical College

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Metastatic Castration-resistant Prostate Cancer

Treatments: Drug: 177Lu-LNC1011

Study type: Interventional

Funder types: Other

Identifiers

NCT06250244

PUMCH-NM-PSMA1011

Details and patient eligibility

About

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).

Full 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 received a dose escalation of 0.925 GBq from the previous cohort.

Enrollment: 12 estimated patients

Sex: Male

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

LNC1011 Dose escalation

Experimental group

Description:

Patients received a single dose of 1.85 GBq (50 mCi) of 177Lu-LNC1011 via intravenous injection, followed by monitoring at 3, 24, 48, 72, and 168 hours post-injection. Subsequent cohorts received a dose escalation of 0.925 GBq from the previous cohort.

Treatment:

Drug: 177Lu-LNC1011