Trial intelligence / Profile preview

177Lu-LNC1011 in mCRPC

NCT06250244Phase 2

Key facts

Status
Recruiting
Start
May 2023
Primary completion
Apr 2025
Countries
1
Sponsor
Peking Union Medical College Hospital
Modality
Small Molecules
Conditions
metastatic castration-resistant prostate cancer (mCRPC)
01

Overview

Phase 2, open-label, single-arm trial of 177Lu-LNC1011 in metastatic castration-resistant prostate cancer (mCRPC), sponsored by Peking Union Medical College Hospital. Primary endpoints: Dosimetry of normal organs and tumors at 4 weeks, Hematologic adverse events collection at 6 months and 1 more. Started May 2023; status: recruiting.

02

Design

1 arm
Study design
Non-randomizedOpen-label
  • LNC1011 Dose Escalation

    Single dose of 177Lu-LNC1011 with sequential dose escalation (3+3 design).

03

Who it enrols

Patients with progressive metastatic castration-resistant prostate cancer and high PSMA expression on PET/CT. Excludes patients with significant renal, hepatic, or hematologic impairment.

04

Endpoints

Primary

  • Dosimetry of normal organs and tumors

  • Hematologic adverse events collection

  • Liver and renal toxic events collection

Secondary

  • PSA Response

  • Pharmacokinetics and dosimetry

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