Actively Recruiting
A Two-part Phase 1 Open-label Safety and Pharmacokinetic Study of Intravenous RC220 in Combination With Doxorubicin in Adult Patients With Solid Tumours.
Led by Racura Oncology Ltd · Updated on 2026-06-02
53
Participants Needed
9
Research Sites
78 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary cardioprotective and anti-tumor activity of a drug called RC220 combined with doxorubicin in adults with locally advanced unresectable or metastatic solid tumors where doxorubicin could be considered a treatment option. This open-label, phase 1 study is divided into two parts to assess dose escalation and dose expansion in patients with advanced solid tumors. The study has two parts: Part 1 involves a fixed-dose doxorubicin monotherapy lead-in cycle to assess tolerability, followed by dose-escalating intravenous infusions of RC220 alone and combined with doxorubicin every 21 days to determine the maximum tolerated combined dose (MTCD). Part 2 will evaluate the MTCD's safety, tolerability, and preliminary cardioprotective and anti-tumor effects in an expanded group of patients who have not previously received anthracycline treatment and for whom doxorubicin is indicated. Participants will undergo cycles of treatment starting with doxorubicin alone, then RC220 alone, and then RC220 combined with doxorubicin every 21 days until disease progression, unacceptable toxicity, or withdrawal. Throughout the study, safety and tolerability will be closely monitored, and blood and biomarker samples will be collected. The main outcomes include incidence of dose-limiting toxicities, adverse events, and measures of tumor response and cardiac function over up to 12 months.
CONDITIONS
Brief 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 between 18 and 80 years at the time of consent.
- Life expectancy of at least 3 months.
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
- Measurable or evaluable disease per RECIST v1.1 without prior radiation or local treatment unless progression documented.
- Adequate bone marrow, liver, and kidney function.
- INR/PT less than 2 times upper limit of normal (ULN) and aPTT less than or equal to 1.5 times ULN.
- Use of effective contraceptive measures as specified for males and females.
- Part 1 specific: Histologically or cytologically confirmed advanced solid tumors where anthracycline may be considered; additional hepatic function requirements.
- Part 2 specific: Histologically or cytologically confirmed solid tumors without prior anthracycline treatment and where doxorubicin is indicated; specific hepatic function requirements.
You will not qualify if you...
- Pregnant or nursing females.
- Recent cancer-directed therapy within specified timeframes before study treatment.
- Persisting grade 2 or higher adverse events from prior treatment unless approved.
- Primary CNS malignancy or symptomatic CNS metastases.
- Major surgery within 28 days prior to screening.
- History of tissue or organ transplantation.
- Recent use of systemic immunosuppressive medications except allowed exceptions.
- Recent severe infection or active infection signs.
- Active hepatitis B or C infection unless controlled.
- Confirmed HIV infection unless well controlled and approved.
- Inherited bleeding or clotting disorders or recent thromboembolic events.
- Use of medications affecting cytochrome P450 or P-gp enzymes prior to and during the study.
- Severe or uncontrolled cardiac disease or prior anthracycline treatment exceeding lifetime dose limits.
- Known allergies or hypersensitivity to study drugs.
- History of illicit substance abuse that could affect participation.
- Vaccination with live vaccines within 4 weeks prior to first study dose.
- Any other significant medical or psychiatric condition that may affect safety or study integrity.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated 21-day cycles until disease progression or discontinuation
Participants receive an initial 21-day cycle of doxorubicin monotherapy to confirm tolerability, followed by a 21-day cycle of RC220 monotherapy. After confirming safety and tolerability, participants continue with combination treatment of RC220 and doxorubicin every 21 days. Treatment continues until disease progression, unacceptable toxicity, withdrawal of consent, or study end.
1 visit on Day 1 of each 21-day cycle (in-person)
Duration - Up to 12 months after last dose
Participants are monitored for safety and treatment-emergent adverse events for up to 30 days after their last combination dose, with additional assessments for up to 12 months to evaluate response and survival outcomes.
Periodic visits during the 12 months following treatment completion
Trial Site Locations
Total: 9 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
6
Asan Medical Centre
Seoul, South Korea
Not Yet Recruiting
7
Ewha Womans University MokDong Hospital
Seoul, South Korea
Not Yet Recruiting
8
Samsung Medical Centre
Seoul, South Korea
Not Yet Recruiting
9
Severance Hospital, Yonsei University, Health System
Seoul, South Korea
Not Yet Recruiting
Research Team
M
Marinella Messina
C
Corli Merry
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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