The Safety Review Committee (SRC) for a clinical trial has cleared Racura Oncology’s lead oncology drug, RC220 to escalate to the next planned dose level of 100 mg/m2.
The phase 1a/b clinical trial is evaluating RC220 in combination with osimertinib in patients with epidermal growth factor receptor-mutant (EGFR-mutant) non-small cell lung cancer (NSCLC).
The SRC reviewed all safety data from both cohort 1 patients, who received RC220 at 50 mg/m2 by intravenous infusion in combination with osimertinib at 80 mg daily. No dose-limiting toxicities or treatment-related safety concerns were identified in either patient during the safety observation period. The second cohort 1 patient has now received three doses of RC220, administered 21 days apart, without any dose-limiting toxicities or treatment-related safety concerns.
Cohort 1 enrolled two patients after the SRC requested that a second patient receive RC220 at 50 mg/m2. This followed an observation of grade 2 colitis in the first patient outside the trial safety period. Although the cause was undetermined, a contribution from RC220 could not be excluded. The second patient has reported no colitis or other dose limiting symptoms after three separate RC220 doses.
Pre-screening is now underway to enrol the single patient in cohort 2, who is expected to receive RC220 at 100 mg/m2 with osimertinib at 80 mg daily. SRC clearance relates to safety and dose escalation only; this announcement does not include data on the clinical activity of RC220 in this indication.
