Health · Pharma & Biotech · 1 hr ago
Racura trial advances to next RC220 dose after initial safety review
Racura Oncology can test its drug RC220 at a higher dose in a Phase I trial for a form of lung cancer.
The HARNESS-1 trial combines RC220 with osimertinib for people with EGFR-mutant non-small cell lung cancer.
Two patients received the first dose level of 50 mg/m2, and the safety committee found no dose-limiting toxicity or other treatment-related safety concerns during the review period.
One patient had Grade 2 colitis outside that period, and the committee could not rule out a link to RC220, so another patient was treated at the same dose.
The committee approved moving to 100 mg/m2, while keeping osimertinib at 80 mg daily.
Racura is pre-screening to enrol one patient in the next group, and the trial will review safety before any further dose increases.
These early findings involve only two patients at the lowest dose, so the drug’s safety still needs to be assessed in more patients and at higher doses.
Racura Oncology’s RC220 has been cleared to advance to 100 mg/m2 in the Phase I HARNESS-1 lung cancer trial.
The Safety Review Committee approved the dose escalation after reviewing safety data from two patients treated at 50 mg/m2.
Neither patient had dose-limiting toxicity or other treatment-related safety concerns during the safety observation period.
Pre-screening is underway for one Cohort 2 patient, who is expected to receive RC220 with osimertinib.
The trial is testing the combination in patients with EGFR-mutant non-small cell lung cancer.
- Who
- Racura Oncology and the Safety Review Committee. The trial is for patients with EGFR-mutant non-small cell lung cancer.
- What
- The committee approved increasing the RC220 dose to 100 mg/m2 in HARNESS-1.
- When
- The article was published on October 14, 2026; the approval date is not stated.
- Where
- Not stated.
- Why
- The committee reviewed safety data from two Cohort 1 patients and found no dose-limiting toxicity or other treatment-related safety concerns during the safety observation period.
This story does not have two clearly opposing sides.
The first patient experienced Grade 2 colitis outside the safety observation period, and the committee could not rule out a possible role for RC220.
An additional patient received RC220 at 50 mg/m2; the article says the patient had three doses 21 days apart without dose-limiting toxicity or treatment-related safety concerns.
The Safety Review Committee approved progression to 100 mg/m2, and pre-screening began for a Cohort 2 patient.
- Trial
- Phase I HARNESS-1
- Next RC220 dose
- 100 mg/m2
- Cohort 1 RC220 dose
- 50 mg/m2
- Osimertinib dose
- 80 mg daily
- Cohort 1 patients reviewed
- 2
- Cohort 2 plan
- One patient is expected to receive RC220 at 100 mg/m2 with osimertinib at 80 mg daily
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