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A Two-part Phase 1 Open-label Safety and Pharmacokinetic Study of Intravenous RC220 in Combination With Doxorubicin in Adult Patients With Solid Tumours.

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Trial Profile

A Two-part Phase 1 Open-label Safety and Pharmacokinetic Study of Intravenous RC220 in Combination With Doxorubicin in Adult Patients With Solid Tumours.

Status: Recruiting
Phase of Trial: Phase I

Latest Information Update: 03 Jun 2026

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At a glance

  • Drugs Bisantrene (Primary) ; Doxorubicin (Primary)
  • Indications Solid tumours
  • Focus Adverse reactions; First in man
  • Sponsors Racura Oncology

Most Recent Events

  • 15 May 2026 According to a Racura Oncology media release, Stage 1 of the trial evaluates ascending doses of RC220 combined with doxorubicin in up to 33 patients. Using a Bayesian design, it aims to determine safety, tolerability, pharmacokinetics, and the MTCD. Following an interim analysis, Stage 2 will assess the optimal dosage in an additional 20 patients to evaluate further safety and preliminary cardioprotective and anticancer efficacy.
  • 15 May 2026 According to a Racura oncology media release, Based on this positive SRC recommendation, Racura plans to proceed to screening of new eligible patients for enrolment in Cohort 2 (80mg/m2 RC220 dose level) using an updated trial protocol, which includes an initial lead-in safety monotherapy cycle of doxorubicin prior to the administration of RC220. This protocol update enables an assessment of the anthracycline-cardioprotective potential of RC220 using a blood-based molecular test.
  • 15 May 2026 According to a Racura oncology media release, company announced that the independent Safety Review Committee (SRC) has completed its review of safety data from Cohort 1 of the ongoing CPACS clinical trial, evaluating the safety and pharmacokinetics of RC220 alone and in combination with doxorubicin in advanced metastatic solid tumor patients.

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