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

Last updated: December 6, 2024
Sponsor: Peking Union Medical College Hospital
Overall Status: Active - Recruiting

Phase

1/2

Condition

Urologic Cancer

Prostate Cancer, Early, Recurrent

Prostate Cancer

Treatment

177Lu-LNC1011

Clinical Study ID

NCT06250244
PUMCH-NM-PSMA1011
  • Ages 18-80
  • Male

Study Summary

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 Criteria

Inclusion

Inclusion Criteria:

  • progressive metastatic castration-resistant prostate cancer

  • tumors with high PSMA expression confirmed on 68Ga-PSMA PET/CT PSMA expressionconfirmed on 68Ga-PSMA PET/CT

Exclusion

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

Study Design

Total Participants: 12
Treatment Group(s): 1
Primary Treatment: 177Lu-LNC1011
Phase: 1/2
Study Start date:
May 01, 2023
Estimated Completion Date:
October 01, 2025

Study 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.

Connect with a study center

  • Peking Union Medical College Hospital

    Beijing, Beijing 100730
    China

    Active - Recruiting

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