The Safety Review Committee (SRC) has cleared **Racura Oncology's** (ASX: RAC) CPACS Phase 1 trial to escalate the RC220 dose for Cohort 2.
This means the trial can now proceed from 40mg/m2 to the next designated dose level of 80mg/m2 in combination with doxorubicin.
Crucially, the SRC reported no treatment-related safety concerns or dose-limiting toxicities in the first three Cohort 1 patients.
All patients on trial remain alive despite their advanced metastatic solid tumour status at enrolment.
Patient screening for Cohort 2 is currently underway across Australia, Hong Kong, and South Korea.
Enhanced Cardioprotection Assessment Protocol
Racura Oncology has implemented an updated protocol for Cohort 2 enrolment.
This revised protocol includes an initial doxorubicin lead-in safety monotherapy cycle before RC220 is administered.
A significant addition is the incorporation of a blood-based molecular test assessment.
This test aims to enhance the evaluation of RC220's cardioprotective potential.
Existing Cohort 1 patients will also transition to this updated protocol for their future cycles.
Ongoing RC220 Development
This progress builds on earlier developments for RC220.
Racura Oncology previously confirmed the safe dosing of the third CPACS patient in Hong Kong at 40 mg/m2, with no adverse events reported.
Beyond the CPACS program, the company also saw the first patient recruited to its HARNESS-1 Phase 1a/b trial for EGFR-mutant NSCLC, assessing RC220 with osimertinib.
Furthermore, preclinical data presented at AACR 2026 reinforced RC220's mechanism of action through c-MYC silencing.
Financial Position and Runway
Racura Oncology maintains a robust financial position.
The company reported a cash and cash equivalents balance of A$19.38 million as of 31 March 2026 that is set to support the company's committed activities through CY2027.
More than 81% of the company's spending for the quarter was directed towards research and development and drug manufacturing activities, highlighting its focus on advancing its pipeline.
Racura Oncology's successful safety review for its CPACS Phase 1 trial allows for dose escalation of RC220, supported by an updated protocol to better assess cardioprotective potential.
This progress, alongside ongoing trial recruitment and preclinical data, strengthens the development narrative for RC220, while the company maintains a robust cash runway through CY2027.
