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Highlights
- Radiopharm Theranostics begins enrolment for the third cohort in its Phase 1 dose escalation trial of 177Lu-RAD204.
- The Data Safety Monitoring Committee (DSMC) has approved advancing to a higher 90mCi dose level.
- The first two cohorts showed tumour uptake and a favourable safety profile.
Radiopharm Theranostics Limited (ASX:RAD) (Nasdaq:RADX), a clinical-stage biopharmaceutical company, is set to begin patient enrolment for the third cohort of its Phase 1 clinical trial evaluating 177Lu-RAD204. This trial is designed to test escalating doses of 177Lu-RAD204 in patients with PD-L1 positive advanced cancers.
This development follows the completion of enrolment in the second cohort, and approval from the Data Safety Monitoring Committee to proceed to a higher dose of 90mCi.
Positive Early Findings
The first two patient cohorts have demonstrated tumour uptake and a favourable safety profile. The ongoing trial includes patients with PD-L1 positive advanced cancers, such as 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.
About the Phase 1 Trial
About 177Lu-RAD204
The therapy 177Lu-RAD204 is an sdAb (single-domain monoclonal antibody) that targets PD-L1, a protein found in several solid cancers and regulate immune system activity. This makes PD-L1 an important therapeutic target across multiple tumour types.
Imaging data from a prior Phase 1 study, which involved 16 patients with NSCLC, indicated that a diagnostic version of the compound, 99Tc-RAD204, was safe and had acceptable radiation dose levels (dosimetry).
The company stated that the tumour-targeting agents like 177Lu-RAD204 have the potential to overcome resistance mechanisms seen with current standard-of-care treatments.
RAD shares were trading at AUD 0.024 per share at the time of writing on 12 November 2025.
