Clinical Trials

Clinical Trials

Racura Oncology aims to improve the lives of cancer patients by developing a novel formulation of (E,E)-bisantrene called RC220.

Racura has two Phase 1 clinical trials of RC220 recruiting (CPACS and HARNESS-1), and a Phase 3 r/r AML trial (EMILI-3) expected to be open for patient recruitment in late 2026.

CPACS.  RC220 in combination with doxorubicin in adult participants with advanced solid tumours

This Phase 1 clinical trial aims to investigate the safety, tolerability and pharmacokinetics of RC220 bisantrene in combination with doxorubicin in patients with advanced solid tumours.

This trial is being conducted at several sites in Australia, Hong Kong and South Korea.

Trial Status: Active, recruiting

For additional information about the trial including entry criteria for involvement and clinical site locations, please visit the website by clicking the button below:

HARNESS-1. RC220 in combination with osimertinib in EGFRm Non-small Cell Lung Cancer patients

The HARNESS-1 trial is a multi-centre, Phase 1a/b study, using circulating tumour DNA (ctDNA) to screen and enrol EGFRm NSCLC patients receiving treatment with osimertinib. The trial will commence with a ctDNA screening stage, followed by dose escalation of RC220 when patients have evidence of disease progression, where between 12 and 40 patients will receive intravenous (IV) infusion of RC220 on Day 1 of a 21-day cycle in combination with standard-of-care maintenance osimertinib therapy. This treatment stage will begin by enrolling participants into single-patient cohorts under an accelerated trial design (ATD), intended to balance the need for careful safety evaluation with the objective of reaching clinically active dose levels as quickly as possible. Once the ATD stage is complete, participants will be enrolled into a Bayesian Optimal Interval (BOIN) dose escalation study, using larger patient cohorts to identify the maximum tolerated dose (MTD) of RC220. Participants in the trial will continue to be treated with RC220 and osimertinib until they reach any of the following outcomes: successful control of disease or one year of treatment; disease progression; unacceptable toxicity; or withdrawal of consent.

Once the MTD of RC220 has been determined, all accumulated safety and PK data will be analysed before initiation of the double-blind, randomised dose expansion Phase 1b stage. In this stage, 40 participants will be randomised to one of two RC220 dose levels in combination with standard of care osimertinib. Patients will be monitored for safety and PK, together with a range of secondary and exploratory endpoints, including: progression-free survival (PFS), overall survival (OS); changes in levels of ctDNA; and changes in the cancer-specific mutations present in patients.

This trial is being conducted at several sites in Australia.

Trial Status: Active, recruiting

For additional information about the trial including entry criteria for involvement and clinical site locations, please visit the website by clicking the button below: