NCT06815575

A Safety and Pharmacokinetics Study of RC220 Combined With Doxorubicin in Adult Participants With Solid Tumours.

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: Phase 1
• Study type: Interventional
• Enrollment: 53 (estimated)
• Sponsor: Race Oncology Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a multi-centre, two-part, open-label, phase 1, first in human study of multiple ascending doses of RC220 bisantrene formulation alone and in combination with fixed dose doxorubicin to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) in adult patients with advanced solid tumours where an anthracycline may be considered as a treatment option / or is indicated. The study will consist of Part 1 - dose-escalation, to determine the maximum tolerated combination dose of RC220 with doxorubicin to be evaluated in Part 2 - dose-expansion cohort, in patients with solid tumours that are anthracycline treatment naïve and for whom treatment with doxorubicin is indicated. The objective of Part 2 will be to confirm the safety and tolerability and evaluate the preliminary cardioprotective and anti-tumour efficacy of the maximum tolerated combined dose (MTCD) of RC220 with doxorubicin.

Detailed description

This study is an open-label, Phase 1 dose escalation trial with expansion cohort to investigate the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary cardioprotective and antitumor activity of RC220 in combination with doxorubicin in patients with advanced solid tumours. The study is divided into two parts: dose escalation (Part 1), and dose expansion (Part 2). In Part 1(Dose Escalation), patients will be enrolled sequentially into escalating dose cohorts up to 5 planned dose cohorts. Each patient in a dose cohort will receive an intravenous (IV) infusion of RC220 on Day 1 of the lead-in 21-day cycle and continue to the combination cycle, where patients will receive IV RC220 followed by IV doxorubicin on Day 1 of a 21-day cycle . New patients will be enrolled in each dose escalation cohort based on safety observed during the first 21 days of RC220 and doxorubicin combination treatment Cycle 1 until the MTCD is defined based on the recommendations of the Safety Review Committee (SRC). Patients will continue to be treated beyond the first combination cycle observation period until disease progression, unacceptable toxicity, withdrawal of consent or defined end of study, whichever occurs first. An interim analysis of the accumulated safety, PK, early efficacy and PD (as available) will be conducted to confirm the MTCD of RC220 in combination with fixed dose doxorubicin for further evaluation of the safety and tolerability, preliminary cardioprotective and anti-tumour efficacy in an exploratory dose expansion cohort of patients with solid tumours that are anthracycline treatment naïve and for whom treatment with doxorubicin is indicated.

Conditions

• Solid Tumours
• Advanced Solid Tumours

Interventions

Type	Name	Description
DRUG	RC220	Administered by intravenous infusion over 60 minutes.
DRUG	Doxorubicin (Adriamycin)	60 mg/m2 administered by intravenous infusion over 10 minutes following adminstration of intravenous RC220 on Day 1 of the combination cycles.

Timeline

• Start date: 2025-04-02
• Primary completion: 2027-07-31
• Completion: 2029-01-31
• First posted: 2025-02-07
• Last updated: 2025-12-17

Locations

5 sites across 2 countries: Australia, Hong Kong