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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 2025-12-17

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 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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Race Oncology Ltd

    lead INDUSTRY

Principal Investigators

  • Marinella Messina · Race Oncology Ltd

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 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

Study Locations

More Related Trials

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