Actively Recruiting
A Safety and Pharmacokinetics Study of RC220 Combined With Doxorubicin in Adult Participants With Solid Tumours.
Led by Racura Oncology Ltd · Updated on 2025-12-17
53
Participants Needed
5
Research Sites
200 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
A Safety and Pharmacokinetics Study of RC220 Combined With Doxorubicin in Adult Participants With Solid Tumours.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to give voluntary informed consent and willing to complete all study procedures
- Aged 18 years or older at consent
- Life expectancy of at least 3 months
- Measurable or evaluable disease per RECIST v1.1 without recent radiation to target lesions unless progression documented
- Adequate bone marrow function: ANC ≥ 1.5 x 10^9/L without growth factor support in prior 2 weeks; hemoglobin ≥ 90 g/L without transfusion or growth factor in prior 2 weeks; platelet count ≥ 100 x 10^9/L without transfusion in prior 2 weeks
- Adequate liver function: AST and ALT < 3x upper limit of normal (ULN), or < 5x ULN if liver metastases or hepatocellular carcinoma (HCC)
- Adequate kidney function: serum creatinine < 1.5x ULN or creatinine clearance > 50 mL/min
- INR/PT < 2x ULN and aPTT ≤ 1.5x ULN
- Practice adequate contraception as specified for females and males during study and for 90 days after last dose
- Part 1: Confirmed locally advanced unresectable or metastatic solid tumors with prior treatment failure where anthracycline may be considered; ECOG performance status ≤ 1; specific bilirubin limits depending on condition
- Part 2: Confirmed solid tumors with no prior anthracycline treatment where doxorubicin is indicated; ECOG performance status ≤ 2; specified bilirubin limits
You will not qualify if you...
- Females who are pregnant or nursing
- Recent cancer-directed therapy within specified timeframes (chemotherapy, radiation, investigational agents)
- Persisting grade 2 or higher adverse events from prior treatment unless approved
- Primary CNS malignancy or symptomatic CNS metastases; asymptomatic CNS metastases must be controlled
- Major surgery within 28 days before screening (except central venous catheter placement)
- History of tissue or organ transplantation
- Use of systemic immunosuppressive medications within 4 weeks before study drug
- Recent severe infection or active infection within 2 weeks before dosing
- Active hepatitis B or C without viral clearance or well-controlled HIV infection without approval
- Bleeding or clotting disorders, recent thromboembolic events, or conditions increasing bleeding risk
- Use of medications likely to increase serious neutropenic complications
- Significant medical or psychiatric illness that may affect safety or study participation
- Known allergies or intolerance to study drugs
- History of illicit substance abuse unless clinically justified
- Live vaccine within 4 weeks before dosing
- Use of medications affecting cytochrome P450 enzymes or P-glycoprotein within 14 days or 5 half-lives before dosing
- Part 1: Severe or uncontrolled cardiac disease, recent myocardial infarction, serious arrhythmias
- Part 1: Prior anthracycline treatment exceeding maximum lifetime dose unless approved
- Part 2: Uncontrolled or severe cardiac disease preventing doxorubicin treatment
AI-Screening
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Trial Site Locations
Total: 5 locations
1
Gosford Hospital
Gosford, New South Wales, Australia, 2250
Actively Recruiting
2
Cancer Care Foundation
Miranda, New South Wales, Australia, 2228
Actively Recruiting
3
Wyong Hospital
Wyong, New South Wales, Australia, 2259
Actively Recruiting
4
Queen Mary Hospital
Hong Kong, Hong Kong, 999077
Actively Recruiting
5
Prince of Wales Hospital
Shatin, Hong Kong
Actively Recruiting
Research Team
M
Michelle Huh
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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