Full Press Release Details
Theranostics starts enrollment of the Third Cohort of Phase 1 Dose Escalation Clinical Trial of 177Lu-RAD204
Data Safety Monitoring Committee approves advancing
to a higher dose of 90mCi
The first two Cohorts' patients show tumor
uptake and a favourable safety profile
Sydney, Australia - 12 November 2025 - Radiopharm Theranostics
(ASX: RAD, Nasdaq: RADX, "Radiopharm" or the "Company"), a clinical-stage biopharmaceutical company focused on
developing innovative oncology radiopharmaceuticals for areas of high unmet medical need, today announced the completion of enrollment
for the second cohort of patients in the Phase 1 dose escalation trial of 177Lu-RAD204 in PD-L1 positive advanced cancers, including non-small
cell lung cancer (NSCLC), small cell lung cancer (SCLC), triple-negative breast cancer (TNBC), cutaneous melanoma, head and neck squamous
cell carcinoma (HNSCC) and endometrial cancer.
"We continue to execute to plan and are pleased to have completed
enrollment of the second cohort of patients in the Phase 1 study of RAD204," said Riccardo Canevari, CEO and Managing Director of
Radiopharm Theranostics. "This represents a major milestone for Radiopharm Theranostics, as we can now proceed in dosing patients
in the Third Cohort with a dose of 90mCi of Lu177, as approved by the Data and Safety Monitoring Committee. Our basket trial is
targeting multiple tumor types including NSCLC, SCLC, TNBC, Cutaneous Melanoma, HNSCC and endometrial cancer. We look forward to continuing
to collect more patient data, as we believe RAD204 could significantly improve clinical outcomes for patients with PD-L1 positive advanced
cancers who face a life-limiting disease with limited effective treatment options."
The open-label Phase 1 trial, entitled "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 Solid Tumors," is a first-in-human study to evaluate the safety, tolerability, biodistribution,
radiation dosimetry and preliminary anti-tumour activities of 177Lu-RAD2041 in eligible individuals with PD-L1 expressing
RAD204 is a single-domain monoclonal antibody
(sdAb) that targets PD-L1, a protein that helps control the immune system and is overexpressed in many solid cancers, making it an attractive
therapeutic target in multiple tumor types, including NSCLC, SCLC, TNBC, Cutaneous Melanoma, HNSCC, and Endometrial Cancer. Previously
published Phase 1 imaging data of 16 NSCLC patients with 19Tc-RAD204 demonstrated that the diagnostic compound is safe and is associated
with acceptable dosimetry2.
Tumor targeting with radioimmunotherapies such as 177Lu-RAD204 has
the potential to address resistance mechanisms to current standard-of-care treatment options.
Radiopharm Theranostics
Suite 1, Level 3, 62 Lygon Street, Carlton South VIC 3053 Australia
About Radiopharm Theranostics
Radiopharm Theranostics is a clinical stage radiotherapeutics company
developing a world-class platform of innovative radiopharmaceutical products for diagnostic and therapeutic applications in areas of high
unmet medical need. Radiopharm is listed on ASX (RAD) and on NASDAQ (RADX). The company has a pipeline of distinct and highly differentiated
platform technologies spanning peptides, small molecules and monoclonal antibodies for use in cancer. The clinical program includes one
Phase 2 and four Phase 1 trials in a variety of solid tumor cancers including lung, breast, and brain. Learn more at radiopharmtheranostics.com.
Authorized on behalf of the Radiopharm
Theranostics Board of Directors by Executive Chairman Paul Hopper.
For more information:
CEO & Managing Director
Precision AQ (formerly Stern IR)
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Website - https://radiopharmtheranostics.com/
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Radiopharm Theranostics
Suite 1, Level 3, 62 Lygon Street, Carlton South VIC 3053 Australia