Dose Escalation Approved but 177Lu-RAD204 Faces Critical Efficacy Test Ahead
Radiopharm Theranostics has secured Data Safety and Monitoring Committee approval to escalate dosing in its Phase 1 trial of 177Lu-RAD204, expanding patient cohorts across multiple cancer types.
- DSMC approves continuation and dose escalation in Phase 1 trial
- Second cohort dose increased from 40mCi to 60mCi
- Trial expands beyond NSCLC to include five additional tumor types
- Enrollment of first two cohorts expected by mid-2025
- Four active clinical sites recruiting patients in Australia
Positive Safety Review Enables Dose Escalation
Radiopharm Theranostics (ASX: RAD, Nasdaq: RADX) has reached a pivotal milestone in the clinical development of its radiotherapeutic candidate 177Lu-RAD204. The independent Data Safety and Monitoring Committee (DSMC) has reviewed data from the initial cohort of patients and given the green light to proceed with a higher dose in the ongoing Phase 1 trial. This endorsement reflects positive safety, pharmacokinetic, and biodistribution profiles observed at the initial 30mCi dose level.
Expanding the Trial Scope and Accelerating Timelines
With DSMC approval, Radiopharm is now escalating the dose for the second patient cohort to 60mCi, a significant increase from the originally planned 40mCi. This dose escalation is accompanied by an expansion of the trial to include multiple PD-L1 positive advanced cancers beyond the initial focus on Non-Small Cell Lung Cancer (NSCLC). The new cohort will also enroll patients with Small-Cell Lung Cancer, Triple-negative Breast Cancer, Cutaneous Melanoma, head and neck squamous cell carcinoma, and Endometrial Cancer.
The company anticipates completing enrollment of the first two cohorts by mid-2025, supported by four active clinical trial sites in Australia. This acceleration is a strategic move to gather broader clinical data across diverse tumor types, potentially positioning 177Lu-RAD204 as a versatile radiopharmaceutical in oncology.
The Promise of 177Lu-RAD204 in Oncology
177Lu-RAD204 is a single-domain monoclonal antibody targeting PD-L1, a protein that modulates immune response and is overexpressed in many solid tumors. By delivering targeted radiation, this therapy aims to overcome resistance mechanisms that limit the effectiveness of current treatments. Earlier imaging studies have demonstrated the compound’s safety and favorable dosimetry, laying a foundation for therapeutic exploration.
Radiopharm’s CEO Riccardo Canevari expressed optimism about the trial’s progress, highlighting the potential for improved clinical outcomes in patients with PD-L1 positive cancers. The company’s broader pipeline and ongoing clinical programs underscore its commitment to advancing innovative radiopharmaceuticals in areas of high unmet medical need.
Looking Ahead
As Radiopharm Theranostics pushes forward with this dose escalation and cohort expansion, the oncology community and investors alike will be watching closely for forthcoming data releases. These results will be critical in validating the therapeutic promise of 177Lu-RAD204 and shaping its future development trajectory.
Bottom Line?
Radiopharm’s accelerated Phase 1 trial progression signals growing confidence but hinges on upcoming efficacy data.
Questions in the middle?
- How will the increased 60mCi dose impact safety and efficacy outcomes?
- What preliminary efficacy signals might emerge from the expanded tumor cohorts?
- Could this trial progression attract new partnerships or investment interest?
