The HARNESS-1 trial, which evaluates RC220 in combination with osimertinib for patients with EGFR-mutant non-small cell lung cancer, utilized an accelerated titration design to reach this milestone. While the first cohort initially raised concerns after a patient experienced Grade 2 colitis outside the formal safety window, a second patient completed three doses without adverse symptoms, prompting the committee to greenlight the dose increase.
Racura Oncology Advances RC220 Lung Cancer Trial to 100 mg/m2
The Safety Review Committee for the HARNESS-1 clinical trial has cleared Racura Oncology to escalate the dosage of its lead drug, RC220, to 100 mg/m2. The decision follows a successful safety observation period in which two patients receiving the initial 50 mg/m2 dose showed no dose-limiting toxicities.
RC220 functions by targeting G-quadruplex DNA and RNA structures to silence the MYC gene, a common driver of malignant growth. The trial is currently pre-screening for the next participant to receive the 100 mg/m2 dose. CEO Daniel Tillett noted that while this stage focuses exclusively on safety and dose escalation, the company plans to transition to a Bayesian Optimal Interval design after testing the 150 mg/m2 level to identify the maximum tolerated dose for future expansion.
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