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Racura Oncology Ltd (ASX:RAC)

ALERT: Price-sensitive ASX Announcement for RAC
Current share price for RAC : $1.630 -0.185 (-10.19%)+
Announcement
Release
12 Oct 2026 8:51AM
Price at Release
$1.815
Full Release
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Summary
Racura Oncology Ltd (ASX: RAC) announced that the HARNESS-1 Safety Review Committee cleared its Phase 1 HARNESS-1 trial to escalate RC220 from 50 mg/m2 to 100 mg/m2 in combination with osimertinib 80 mg daily for patients with EGFR-mutant non-small cell lung cancer, after reviewing safety data from Cohort 1 and finding no dose-limiting toxicities or other treatment-related safety concerns during the observation period in either patient; the company said the second Cohort 1 patient had received three RC220 doses 21 days apart without such issues, noted that a second patient had been added to Cohort 1 after the first patient experienced Grade 2 colitis outside the safety observation period where RC220 could not be excluded as a contributor, clarified that this clearance relates only to safety and dose-escalation rather than efficacy, explained that HARNESS-1 uses an accelerated titration design for the first three single-patient dose levels before potentially moving to a BOIN design, and stated that pre-screening is underway to enrol the single Cohort 2 patient at the 100 mg/m2 dose.
Key Points
  • Racura announced SRC clearance for HARNESS-1 to escalate RC220 to 100 mg/m2.
  • The HARNESS-1 trial is evaluating RC220 with osimertinib in EGFR-mutant non-small cell lung cancer.
  • The SRC reviewed safety data from both Cohort 1 patients treated at 50 mg/m2 RC220 plus osimertinib 80 mg daily.
  • Neither Cohort 1 patient experienced dose-limiting toxicity or other treatment-related safety concerns during the safety observation period.
  • The second Cohort 1 patient received three RC220 doses 21 days apart without dose-limiting toxicities or treatment-related safety concerns.
  • A second patient was added to Cohort 1 after the first patient experienced Grade 2 colitis outside the safety observation period.
  • Racura said the cause of the colitis could not be determined and RC220 could not be excluded by the SRC.
  • Pre-screening is underway for the single Cohort 2 patient, who will receive RC220 at 100 mg/m2.
  • The company emphasised that dose-escalation clearance does not demonstrate efficacy or prove RC220 is safe and effective overall.
  • HARNESS-1 uses an accelerated titration design for the first three dose levels of 50, 100 and 150 mg/m2 before potentially transitioning to a BOIN design at 200 mg/m2.
  • Racura said future market updates will depend on trial progress, including enrolment, dosing, safety review, dose escalation and any early efficacy signals.
  • CEO and Managing Director Dr Daniel Tillett described the SRC clearance as an important early milestone in the HARNESS-1 clinical development plan.
IMPORTANT NOTE: This information is autogenerated and has not been reviewed for accuracy or completeness. You should refer to the full announcement here for further information.