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Single-arm, open-label study of 177Lu-RAD204 consisting of a Phase 0 Imaging Period (Im) and a Phase 1 Treatment Period (Tr).

177Lu-RAD204 administered at Imaging (im) and Treatment (tr) doses

177Lu-RAD204

Kenneth O'Byrne, MD

Daniel Brungs, MD

Joe Cardaci, MD

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.

177Lu-anti-PD-L1 sdAb in Metastatic Non-small Cell Lung Cancer

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

Standard of care imaging may include but is not limited to 18F-FDG-PET, CT-scan and/or 99mTc-MDP-bone

Percent of the injected activity vs time for selected organs and tumors

Absorbed radiation doses of 177Lu-RAD204im in critical organs (e.g., kidneys, bone marrow)

Time-integrated activity coefficients of 177Lu-RAD204im in organs and tumor lesions

The properties, incidence, nature and severity of AEs and SAEs per Common Terminology Criteria for Adverse Events (CTCAE) v5.0

Incidence of dose-limiting toxicities (DLTs) during the first 6 weeks following 177Lu-RAD204tr injection cycle of treatment

Incidence of dose-limiting toxicities (DLTs) in the first 2 weeks following 177Lu-RAD204im injection

Objective response rates (ORR) as assessed by RECIST v1.1

Absorbed radiation doses of 177Lu-RAD204tr in critical organs (e.g., kidneys, bone marrow)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
177Lu-anti-PD-L1 sdAb in Metastatic Non-small Cell Lung Cancer	NCT06305962	PDL1 Gene Mutat... Non Small Cell ...	177Lu-RAD204	18 Years -	Radiopharm Theranostics, Ltd
177Lu-anti-PD-L1 sdAb in Metastatic Non-small Cell Lung Cancer	NCT06305962	PDL1 Gene Mutat... Non Small Cell ...	177Lu-RAD204	18 Years -	Radiopharm Theranostics, Ltd

Spots Global Cancer Trial Database for pdl1 positive