TheranosticTrials.org
Radiopharm Theranostics

Clinical Trial · NCT06305962

Phase 0/1 Study of the Safety and Tolerability of 177Lu-RAD204, a Lutetium-177 Radiolabelled Single Domain Antibody Against Programmed Cell Death-Ligand 1 in Patients With Metastatic Non-small Cell Lung Cancer

Overview

This is a first-in-human, open-label study consisting of a Screening Period, an Imaging Period, and a Treatment Period in eligible non-small lung cancer patients who are positive for the biomarker PDL-1. The Screening period lasts up to 4 weeks. The Phase 0 (Imaging Period) is used to determine if patient's tumor(s) are still positive for the biomarker, as well as radiation dosimetry with low dose 177Lu-RAD204im (for a period of up to 2 weeks following the first injection of 177Lu-RAD204im), to assess the safety of the drug. Following the 2 week safety assessment, the subject is eligible to enter Phase I (Treatment Period) with gradual dose increases of 177Lu-RAD204tr. The Treatment Period lasts up to 3 cycles every 6 weeks, with additional extension to a maximum study dose interval of 12 weeks to be approved on a case-by-case basis in discussion with study Sponsor. During the Treatment Period, subjects will be assessed for both safety and treatment response using conventional images and clinical laboratory tests.

Sponsor

Radiopharm Theranostics

Phase

Early Phase 1

Contacts

Daniel Brungs

daniel.brungs@health.nsw.gov.au

ClinicalTrials.gov

NCT06305962

Drug / Compound

Isotope(s):
Target(s):
  • PD-L1
Ligand Class: Small Protiens and Antibody Fragments

Eligibility

Inclusion

  • Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
  • Participants with a documented history of histopathologically confirmed metastatic NSCLC
  • Must have at least 1 measurable target lesion according to RECIST version 1.1
  • Participants with PD-L1 positive NSCLC
  • Participants must have a life expectancy of ≥4 months

Exclusion

  • Patients requiring blood transfusion within 4 weeks of first dose of 177Lu-RAD204 are not eligible to participate
  • Residual toxicity ≥ Grade 2 from prior anti-cancer therapy (except alopecia).
  • Inadequate organ functions as reflected in specific laboratory parameters
  • History of prior organ transplant
  • Any other known, active malignancy, except for treated cervical intraepithelial neoplasia or non-melanoma skin cancer

Patient Education

Patient education not yet provided.

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