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

NCT06815575 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 53

Last updated 2026-06-02

No results posted yet for this study

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 locally advanced unresectable or metastatic solid tumours where doxorubicin may be considered as a treatment option / or is indicated.

The study will consist of two parts: Part 1 - This part involves a fixed-dose doxorubicin (60 mg/m2) tolerability lead-in period, followed by dose-escalating doses of IV RC220 alone, and in combination, with fixed dose doxorubicin, to determine the maximum tolerated combined dose (MTCD) of RC220 with doxorubicin to be evaluated in Part 2. This dose-expansion cohort will enrol 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.

Conditions

Interventions

DRUG

RC220

The assigned dose will be administered by intravenous infusion over 60 minutes.

DRUG

Doxorubicin (Adriamycin)

60 mg/m2 administered by intravenous infusion over 10 minutes on Day 1 of the monotherapy lead-in cycle (M1) and on Day 1 of each 21-day combination cycle following administration of intravenous RC220

Sponsors & Collaborators

  • Racura Oncology Ltd

    lead INDUSTRY

Principal Investigators

  • Marinella Messina · Racura Oncology Ltd

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-02
Primary Completion
2027-07-31
Completion
2029-01-31

Countries

  • Australia
  • Hong Kong
  • South Korea

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06815575 on ClinicalTrials.gov