Racura Oncology has announced that the Safety Review Committee (SRC) overseeing its phase 1 CPACS clinical trial has approved escalation of the investigational drug RC220 to the next designated dose level of 80mg/m². The decision follows a review of safety and pharmacokinetic data from the first patient cohort treated at the 40mg/m² dose level.

According to the company, the SRC confirmed that RC220 demonstrated an acceptable safety profile in the initial cohort, with no dose-limiting toxicities or major safety concerns identified during the observation period. Racura also noted that all patients enrolled in the study remain alive despite having advanced metastatic solid tumours at the time of enrolment.

The first cohort of patients received RC220 as monotherapy at a dose of 40mg/m², followed by up to six combination treatment cycles involving RC220 and the standard chemotherapy drug doxorubicin administered at the standard-of-care dose of 60mg/m².

Dr. Daniel Tillett, CEO and Managing Director of Racura Oncology, described the milestone as an important step in the company’s clinical development programme. He said the absence of dose-limiting toxicities, particularly when RC220 was combined with standard doses of doxorubicin, was highly encouraging. Dr Tillett also acknowledged the contribution of trial participants and their families in supporting the study.

The company has now begun screening eligible patients for Cohort 2, which will evaluate RC220 at the higher 80mg/m² dose level. Racura stated that the updated study protocol includes an initial lead-in cycle of doxorubicin monotherapy prior to administration of RC220. This modification is intended to support assessment of RC220’s potential cardioprotective effects against anthracycline-related toxicity using a blood-based molecular test.

Patients from Cohort 1 who continue treatment will also transition to the revised protocol for future treatment cycles.

RC220 is based on Racura’s lead asset, (E,E)-bisantrene, a small-molecule anti-cancer therapy designed to target G4-DNA and RNA structures, leading to suppression of MYC, a key regulator involved in cancer growth and progression. The company said the therapy has previously demonstrated anti-cancer activity with a well-characterised safety profile.

Racura Oncology is currently focused on advancing therapies aimed at treating cancer through novel molecular targeting approaches, with its clinical development efforts centred on improving treatment outcomes for patients with advanced malignancies.