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
Description:
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 TheranosticsContacts:
Daniel Brungsdaniel.brungs@health.nsw.gov.au
Government Study Link:
NCT06305962 - Click here to see study onClinicalTrials.gov
- PD-L1
- 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
- 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
Locations
Australia 🇦🇺
Woolloongabba, Queensland, Australia
Principal Investigator
Kenneth O'Byrne, MD
Wollongong, New South Wales, Australia
Principal Investigator
Daniel Brungs, MD
Nedlands, Western Australia, Australia
Principal Investigator
Joe Cardaci, MD
