Solid TumoursPhase 1NCT06815575
A Safety and Pharmacokinetics Study of RC220 Combined With Doxorubicin in Adult Participants With Solid Tumours.
A Phase 1 study testing RC220 and Doxorubicin (Adriamycin) in people with Solid Tumours and Advanced Solid Tumours, run by Racura Oncology Ltd at 9 sites in 3 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Solid Tumours, Advanced Solid Tumours
- What is being tested?
- RC220 and Doxorubicin (Adriamycin)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 9 sitesin 3 countries
- Study dates
- 2 Apr 2025to 31 Jan 2029
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able to give voluntary informed consent and understand the study and are willing to follow and complete all the study required procedures.
- Aged between 18 years to ≤ 80 years at the time of informed consent. Note: In Korea, only participants aged ≥19 years at the time of informed consent will be enrolled
- Life expectancy ≥ 3 months.
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
- Have measurable or evaluable disease per RECIST v1.1. The target lesions must not have prior radiation or other locally treated area unless imaging-based progression has been clearly documented following radiation or other local therapy.
- Adequate haematological, liver, and kidney function as follows:
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- Bone marrow reserve:
- Absolute neutrophil count (ANC) ≥ 1.5 × 109/L without growth factor support in the 2 weeks prior to study entry.
- Haemoglobin ≥ 90 g/L without transfusion and/or without growth factor support in 2 weeks prior to study entry.
- Platelet count ≥ 100 × 109/L without transfusion in 2 weeks prior to study entry.
- Hepatic function:
- Aspartate aminotransferase (AST), alanine aminotransferase (ALT) < 3 × upper limit of normal (ULN) (≤5 × ULN if liver metastases or hepatic cell carcinoma (HCC)).
- Renal function:
- Serum creatinine < 1.5 × ULN or Serum creatinine clearance (CrCL) > 50 mL/min, as per the Cockcroft-Gault Equation Glomerular Filtration Rate: [(140-age in years) × weight in kg] / (7.2 × serum creatinine in mg/dL) (× 0.85 for females).
- International normalised ratio (INR) /prothrombin time (PT) < 2 x ULN, activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN.
- Practice adequate contraceptive measures as per below:
- Female patients must:
- Be of nonchildbearing potential i.e., surgically sterilised or postmenopausal, or;
- If of childbearing potential, must have a negative serum pregnancy test at Screening and a negative urine pregnancy test before the first study treatment administration and on Day 1 of each Cycle. They must agree not to attempt to become pregnant, must not donate ova, and must agree to use 2 forms of highly effective contraceptive method between signing consent, during the study, and at least 180 days after the last dose of study drug, OR use 1 form of highly effective contraceptive method, plus an additional barrier method of contraception between signing consent, during the study, and at least 180 days after the last dose of study drug.
- Women of childbearing potential with same sex partners (abstinence from penile vaginal intercourse) are eligible when this is their preferred and usual lifestyle.
- Male patients must:
- be willing not to donate sperm and if engaging in sexual intercourse with a female partner who could become pregnant, a willingness to use a condom in addition to having the female partner use a highly effective contraceptive method between signing consent, during the study, and at least 90 days after the last dose of the study treatment.
- PART 1 only - Dose Escalation Specific Inclusion Criteria
- Histologically/cytologically confirmed, locally advanced unresectable or metastatic solid tumours for whom prior treatments have failed, and where an anthracycline may be considered as a treatment option or is indicated.
- Adequate Hepatic function as per below:
- Serum Total bilirubin (TBIL) as per below:
- Patients with documented Gilbert's syndrome - baseline TBIL < 3 × ULN,
- Patient with either HCC or liver metastases - baseline TBIL < 2 × ULN
- All other patients baseline TBIL < 2 × ULN.
- PART 2 only - Exploratory Dose Expansion Specific Inclusion Criteria 8. Histologically/cytologically confirmed solid tumours of any stage for which the patient has not received prior treatment with an anthracycline and for whom treatment with doxorubicin is indicated.
- 9. Adequate Hepatic function as per below:
- Serum TBIL as per below:
- Patients with documented Gilbert's syndrome - baseline TBIL < 3 × ULN,
- Patient with either HCC or liver metastases - baseline TBIL < 3 × ULN
- All other patients baseline TBIL < 2 × ULN.
Who cannot join
- Females who are pregnant or nursing.
- Received cancer-directed therapy within the following timeframes:
- Antitumour therapy (chemotherapy, antibody therapy, molecular targeted therapy, hormonal therapy or investigational agent) within 28 days prior to the first dose of study treatment (or 5 times the half-life if shorter than 28 days, there can be exceptions on a case-by-case as approved by Study Medical Monitor based on pharmacology). Note: concurrent use of hormone deprivation therapy for hormone-refractory prostate cancer, bisphosphonate or denosumab for skeletal related events per institution guideline is permitted.
- Wide-field radiation therapy within 28 days (or palliative radiation therapy within 7 days) prior to the first dose of study treatment or has not recovered from the side effects of radiation therapy in the opinion of the Investigator.
- Any other concurrent investigational device(s) or conventional agent(s) within 28 days (unless 5 times the half-life is shorter than 28 days) prior to the first dose of study treatment.
- Therapeutic radiopharmaceuticals must be stopped 8 weeks prior to the first dose of the study treatment.
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- Persisting Grade 2 or higher severity AEs from prior antitumour treatment as per CTCAE v5.0. Patients with pre-existing non-treatable Grade 2 toxicities may be eligible per discretion of the Investigator and with approval from Study Medical Monitor (e.g., Grade 2 chemotherapy induced neuropathy).
- Patients with primary central nervous system (CNS) malignancy, symptomatic CNS metastases, meningeal metastases or leptomeningeal disease are not allowed.
- Note: Patients with asymptomatic CNS metastases are eligible if clinically controlled, which is defined as 1) ≥ 4 weeks of stable neurologic function following CNS-directed therapy prior to the first dose of study treatment 2) no evidence of CNS disease progression as determined by radiographic imaging ≥ 4 weeks prior to the first dose of study treatment, 3) ≥ 2 weeks from discontinuation of anti-seizure and steroid therapies (receiving prednisone ≤ 10 mg or equivalent steroid therapies is allowed) prior to the first dose of study treatment.
- Had major surgery within 28-days of the Screening Visit. Note: Patients who have undergone a non-major surgical procedure within 28-days prior to Screening must have recovered adequately from the surgery before the administration of the first dose of study treatment. Exception: no waiting period applies following central venous catheter placement.
- History of tissue or organ transplantation.
- Treatment with systemic immunosuppressive medications within 4 weeks prior to the first dose of study treatment. Exceptions: Daily prednisone equivalent ≤10 mg/day; topical, inhaled, or intranasal corticosteroids.
- History of severe infection deemed clinically significant by the Investigator or designee within 4 weeks or signs and symptoms of any active infection within 2 weeks prior to the first dose of study treatment.
- Active hepatitis B or C. Note: Hepatitis B virus (HBV) carriers without active disease (HBV DNA titer < 1000 copies/mL or 200 IU/mL) or cured hepatitis C (negative HCV RNA test) with confirmed viral clearance that are not receiving ongoing treatment and without residual chronic liver disease may be enrolled.
- Confirmed human immunodeficiency virus (HIV) infection and receiving anti-retroviral therapy (ART). Patients with well controlled HIV infection (i.e., CD4+ count >350 cells/μL and viral copies less than 400/mL after at least 4 weeks of ART) may be eligible per discretion of the Investigator and with approval from Study Medical Monitor.
- Patients with any inherited predisposition to bleeding or to thrombosis (von Willebrand disease, haemophilia, etc.). Patients with a history of nontraumatic haemorrhage (i.e., end stage liver disease, any haemorrhage requiring medical intervention), thromboembolic event or any condition which may increase bleeding risk including clotting disorders, thrombocytopenia during the last 3 months prior to the first dose of study treatment administration.
- Receiving immunosuppressive or myelosuppressive medications that would, in the opinion of the Investigator, increase the risk of serious neutropenic complications.
- Any other disease or clinically significant abnormality in laboratory parameters, including serious medical or psychiatric illness/condition, which in the judgement of the Investigator might compromise the safety of the patient or integrity of the study, interfere with the patient's participation in the trial or compromise the trial objectives.
- Known allergies, hypersensitivity, or intolerance to the study drug or its excipients.
- Any known, documented, or suspected history of illicit substance abuse that would preclude patient from participation, unless clinically justified (i.e., will not interfere with study participation and/or will not compromise trial objectives) per judgement of the Investigator and with approval of Study Medical Monitor. Exception: Physician-prescribed medicinal opioids or cannabinoids are allowed for pain management.
- Vaccinated with any live vaccine within 4 weeks prior to the first dose of study treatment.
- Judgement by the Investigator that the patient is unlikely to comply with study procedures, restrictions and requirements.
- Use of prescription or non-prescription medications, including complementary medicines, within 14 days or 5 half-lives (whichever is longer) if the medication is a potential inhibitor of cytochrome P450 (CYP) isoform 3A4 or 2D6, and/or P-glycoprotein (P-gp), or if the medication is an inducer of CYP3A4 or P-gp, prior to dosing and throughout study participation.
- PART 1 only - Dose Escalation Specific Criteria
- A ≥ 20% decrease in serum albumin from baseline, sustained over two consecutive measurements taken more than 14 days apart during screening prior to the first administration of study treatment.
- Severe or uncontrolled cardiac disease requiring treatment, CHF (New York Heart Association) NYHA III or IV, unstable angina pectoris even if medically controlled, history of myocardial infarction during the 6 months prior to screening, serious arrhythmias requiring medication (with exception of atrial fibrillation or paroxysmal supraventricular tachycardia).
- Treatment with prior anthracyclines exceeding the maximum equivalent cumulative lifetime dose.
- PART 2 only -Dose Expansion Specific Criteria 19. Uncontrolled or severe cardiac disease that in the opinion of the Investigator would prevent treatment with doxorubicin.
Trial locations and contacts
9 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
Corli Merry contact
9 sites in 3 countries
South Korea4 sites, 4 recruiting
- Not yet recruiting
Asan Medical Centre
Seoul
JiYoung Kang, 010-9984-7275, rkdwldud1004@naver.com
Prof. JeongEun Kim
- Not yet recruiting
Ewha Womans University MokDong Hospital
Seoul
HyeMin Choi, 82-2-2650-2811, hyemmmmm@naver.com
Prof. JungMin Jo
- Not yet recruiting
Samsung Medical Centre
Seoul
EunKyung Park, 82-2-2008-4390, ekek.park@samsung.com
Prof JungYong Hong
- Not yet recruiting
Severance Hospital, Yonsei University, Health System
Seoul
YeJi Song, +82-10-2618-7610, YJSONG@yuhs.ac
HyoSong Kim
Australia3 sites, 3 recruiting
- Recruiting
Gosford Hospital
Gosford, New South Wales, 2250
Maree Jarrett, 02 4320 3406, maree.jarrett@health.nsw.gov.au
Dr. Craig Kukard
- Recruiting
Cancer Care Foundation
Miranda, New South Wales, 2228
Kareena Young, 02 8556 9377, kyoung@cancercarefoundation.org.au
Dr Mahmood Alam
- Recruiting
Wyong Hospital
Wyong, New South Wales, 2259
Maree Jarrett, 02 4230 3406, maree.jarrett@health.nsw.gov.au
Dr. Craig Kukard
Hong Kong2 sites, 2 recruiting
- Recruiting
Queen Mary Hospital
Hong Kong, 999077
Dr. Roland Ching Yu Leung, +852 2255 3111, rolandleung2003@yahoo.com
Dr. Roland Ching Yu Leung
- Recruiting
Prince of Wales Hospital
Shatin
Dr. Herbert Ho Fung Loong, +852 3505 1042, H_loong@clo.cuhk.edu.hk
Dr. Herbert Loong
About this study
Official title: A Two-part Phase 1 Open-label Safety and Pharmacokinetic Study of Intravenous RC220 in Combination With Doxorubicin in Adult Patients With Solid Tumours.
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.
Read the 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 with locally advanced unresectable or metastatic solid tumours, where doxorubicin may be considered as a treatment option and/or is indicated will be enrolled. An initial fixed-dose doxorubicin (60 mg/m2) monotherapy 21-day cycle (cycle M1) will be conducted to confirm each patient's tolerability. Patients will be monitored for safety and tolerability, and samples will be collected for PK and PDx biomarker analysis.
Patients who meet the safety and tolerability criteria during cycle M1 will proceed to the RC220 monotherapy lead-in 21-day cycle (cycle M2).
Patients who are unable to tolerate 60 mg/m2 doxorubicin will not be eligible for the study, and those who received a doxorubicin containing regimen of ≥ 60 mg/m2 within 3 months prior to screening, may proceed directly to the RC220 monotherapy lead-in cycle.
During Cycle M2, each patient in a dose cohort will receive an intravenous (IV) infusion of RC220 on Day 1 of the lead-in 21-day cycle. Upon confirmation of safety and tolerability to the RC220 dose, patients will continue to the combination cycle, where patients will receive IV RC220 (at the same dose) 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 Part 1 may be undertaken after the last patient in the dose escalation (Part 1) has completed their end-of-study visit.
Part 2 of the study will evaluate the MTCD of RC220 in combination with doxorubicin in an exploratory expanded cohort of patients to assess the cardioprotective and anti-tumour efficacy in patients with solid tumours that are anthracycline treatment naïve and for whom treatment with doxorubicin is indicated.
- Conditions
- Solid Tumours, Advanced Solid Tumours
- Being tested
- RC220, Doxorubicin (Adriamycin)
- Keywords
- Solid Tumours, Advanced Solid Tumours, Phase 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RC220Drug
The assigned dose will be administered by intravenous infusion over 60 minutes.
Doxorubicin (Adriamycin)Drug
Also called Doxorubicin Hydrochloride, 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
| Study group | Role | What they receive |
|---|---|---|
| Part 1: Dose Escalation | Experimental | Participants will receive
* doxorubicin on Day 1 of a 21-day monotherapy lead-in cycle (M1)
* RC220 on Day 1 of a 21-day monotherapy lead-in cycle (M2)
* RC220 (at the same dose as M2) and doxorubicin combination on Day 1 of a 21-day cycle.
Combination treatment repeats every 21-day cycle in the absence of disease progression or unacceptable toxicity.
The aim is to determine safety, tolerability and maximum tolerated combination dosage level to evaluate in Part 2. Receives: Drug: RC220; Drug: Doxorubicin (Adriamycin) |
| Part 2: Dose Expansion | Experimental | Participants will receive the tolerated and appropriate combination dosage of RC220 with doxorubicin on day 1 of the 21-day cycle and treatment repeats in the absence of disease progression or unacceptable toxicity.
The aim is to provide additional safety and tolerability and potential benefits of the combined dosage. Receives: Drug: RC220; Drug: Doxorubicin (Adriamycin) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part 1. Incidence of dose limiting toxicities (DLTs)
Evaluated at each dose level RC220 combined with doxorubicin, as graded by National Cancer Institute (NCI) Common Terminology for Adverse Events (CTCAE) version 5.0.
Measured: During the first cycle of RC220 and doxorubicin treatment (1-21 days)
Part 1 and Part 2. Treatment emergent adverse events (TEAE) and serious adverse events (SAEs),
This includes clinically significant changes in vital signs, physical examination, electrocardiogram, echocardiogram and clinical laboratory tests, as graded by NCI CTCAE v5.0.
Measured: First dose up to 30 days post last combination dose (up to 12 months)
Secondary outcomes (8)
Part 1. Maximum tolerated combined dose (MTCD)
The MTCD is based on the incidence of Dose Limiting Toxicities (DLTs).
Measured: After the first dose of RC220 and doxorubicin treatment cycle (1-21 days)
Part 1 and Part 2. Best Overall Response (BOR)
Percentage of patients with best confirmed overall response of clinical response (CR) or partial response (PR) (evaluated by the investigator according to RECISTv1.1) until the time of disease progression.
Measured: Up to 12 months
Part 1 and Part 2. Duration of Response (DOR)
Defined as the time from the earliest date documented (CR or PR) (evaluated by the investigator according to RECISTv1.1) until disease progression or death (by any cause, in the absence of progression).
Measured: Up to 12 months
Part 1 and Part 2. Progression Free Survival (PFS)
Defined as the time of first treatment until disease progression or death (by any cause, in the absence of progression).
Measured: Up to 12 months
Part 2. Change from baseline in cardiac blood biomarker levels (hs-troponins and NT-proBNP), as measured by laboratory tests
Measured: up to 12 months
Part 2. Change from baseline in 2D-echocardiogram measurements including GLS, LV volume, LV mass, transmitral flow, atrial volumes.
2D-echocardiograms are performed at specified timepoints. Each time a 2D-echocardiogram is performed, multiple measures will be collected, aggregated and reported on once by a single observer.
Measures collected from each 2D-echocardiogram, and compared to baseline, include:
- global longitudinal strain
- left ventricular mass
- left ventricular volumes
- transmitral flow
- left atrial volume
Measured: Up to 12 months
Part 2. Change from baseline in cardiac magnetic resonance imaging (cMRI) cardiac function parameters (blood flow, global ventricular function, myocardial perfusion)
Each time a cMRI is performed, cMRI images are collected, assessed, compared and reported on in an aggregated manner by an independent cardiologist for changes in cardiac function measures (blood flow, global ventricular function, myocardial perfusion).
Measured: Up to 12 months
Part 2. Change from baseline in functional volume of peak oxygen uptake (VO2 peak). Defined as the highest amount of oxygen consumed at peak exercise.
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2025
- Study start2 Apr 2025
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumoursStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- The Part 1 dose escalation part of the study will enrol up to 33 patients, guided by the Bayesian Optimal Interval (BOIN) design. Patients will be enrolled in cohorts of 3 for each of the 5 planned dose level cohorts. Patients who experience toxicity and withdraw during the doxorubicin tolerability lead-in cycle period will not participate in the dose escalation and may be replaced. The Part 2 exploratory dose expansion part will enrol a single cohort of approximately 20 patients with solid tumours who have not previously been treated with an anthracycline. Patients will be treated at the MTCD of RC220 and doxorubicin as identified in Part 1. The final sample size and patient population for this cohort will be confirmed following the analysis of the accumulated data from Part 1, including safety, PK, PDx and preliminary efficacy outcomes from dose escalation Part 1.
- Masking
- None (open label)
- Enrolment
- 53 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Racura Oncology Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Marinella Messina, Study director, Racura Oncology Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06815575
- Sponsor's protocol ID
- RAC-010
- Status last verified
- May 2026
- First submitted
- 20 Jan 2025
- Last updated
- 2 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Due to the small sample size of this Phase 1 study, individual participant data will not be shared openly to protect participant confidentiality.
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Two-part Phase 1 Open-label Safety and Pharmacokinetic Study of Intravenous RC220 in Combination With Doxorubicin in Adult Patients With Solid Tumours.
- ClinicalTrials.gov ID
- NCT06815575
- Acronym / sponsor ID
- RAC-010
- Conditions
- Solid Tumours, Advanced Solid Tumours
- Keywords
- Solid Tumours, Advanced Solid Tumours, Phase 1
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 53 participants (estimated)
- Lead sponsor
- Racura Oncology LtdIndustry (pharma, biotech, devices)
- Study start
- 2 Apr 2025 (actual)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Jan 2029 (estimated)
- First posted
- 7 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 with locally advanced unresectable or metastatic solid tumours, where doxorubicin may be considered as a treatment option and/or is indicated will be enrolled. An initial fixed-dose doxorubicin (60 mg/m2) monotherapy 21-day cycle (cycle M1) will be conducted to confirm each patient's tolerability. Patients will be monitored for safety and tolerability, and samples will be collected for PK and PDx biomarker analysis.
Patients who meet the safety and tolerability criteria during cycle M1 will proceed to the RC220 monotherapy lead-in 21-day cycle (cycle M2).
Patients who are unable to tolerate 60 mg/m2 doxorubicin will not be eligible for the study, and those who received a doxorubicin containing regimen of ≥ 60 mg/m2 within 3 months prior to screening, may proceed directly to the RC220 monotherapy lead-in cycle.
During Cycle M2, each patient in a dose cohort will receive an intravenous (IV) infusion of RC220 on Day 1 of the lead-in 21-day cycle. Upon confirmation of safety and tolerability to the RC220 dose, patients will continue to the combination cycle, where patients will receive IV RC220 (at the same dose) 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 Part 1 may be undertaken after the last patient in the dose escalation (Part 1) has completed their end-of-study visit.
Part 2 of the study will evaluate the MTCD of RC220 in combination with doxorubicin in an exploratory expanded cohort of patients to assess the cardioprotective and anti-tumour efficacy in patients with solid tumours that are anthracycline treatment naïve and for whom treatment with doxorubicin is indicated.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The Part 1 dose escalation part of the study will enrol up to 33 patients, guided by the Bayesian Optimal Interval (BOIN) design. Patients will be enrolled in cohorts of 3 for each of the 5 planned dose level cohorts. Patients who experience toxicity and withdraw during the doxorubicin tolerability lead-in cycle period will not participate in the dose escalation and may be replaced. The Part 2 exploratory dose expansion part will enrol a single cohort of approximately 20 patients with solid tumours who have not previously been treated with an anthracycline. Patients will be treated at the MTCD of RC220 and doxorubicin as identified in Part 1. The final sample size and patient population for this cohort will be confirmed following the analysis of the accumulated data from Part 1, including safety, PK, PDx and preliminary efficacy outcomes from dose escalation Part 1.
| Arm | Type | Receives |
|---|---|---|
| Part 1: Dose Escalation | Experimental | Drug: RC220, Drug: Doxorubicin (Adriamycin)Participants will receive * doxorubicin on Day 1 of a 21-day monotherapy lead-in cycle (M1) * RC220 on Day 1 of a 21-day monotherapy lead-in cycle (M2) * RC220 (at the same dose as M2) and doxorubicin combination on Day 1 of a 21-day cycle. Combination treatment repeats every 21-day cycle in the absence of disease progression or unacceptable toxicity. The aim is to determine safety, tolerability and maximum tolerated combination dosage level to evaluate in Part 2. |
| Part 2: Dose Expansion | Experimental | Drug: RC220, Drug: Doxorubicin (Adriamycin)Participants will receive the tolerated and appropriate combination dosage of RC220 with doxorubicin on day 1 of the 21-day cycle and treatment repeats in the absence of disease progression or unacceptable toxicity. The aim is to provide additional safety and tolerability and potential benefits of the combined dosage. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (35 listed)
- Able to give voluntary informed consent and understand the study and are willing to follow and complete all the study required procedures.
- Aged between 18 years to ≤ 80 years at the time of informed consent. Note: In Korea, only participants aged ≥19 years at the time of informed consent will be enrolled
- Life expectancy ≥ 3 months.
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
- Have measurable or evaluable disease per RECIST v1.1. The target lesions must not have prior radiation or other locally treated area unless imaging-based progression has been clearly documented following radiation or other local therapy.
Key exclusion criteria (28 listed)
- Females who are pregnant or nursing.
- Received cancer-directed therapy within the following timeframes:
- Persisting Grade 2 or higher severity AEs from prior antitumour treatment as per CTCAE v5.0. Patients with pre-existing non-treatable Grade 2 toxicities may be eligible per discretion of the Investigator and with approval from Study Medical Monitor (e.g., Grade 2 chemotherapy induced neuropathy).
- Patients with primary central nervous system (CNS) malignancy, symptomatic CNS metastases, meningeal metastases or leptomeningeal disease are not allowed.
- Note: Patients with asymptomatic CNS metastases are eligible if clinically controlled, which is defined as 1) ≥ 4 weeks of stable neurologic function following CNS-directed therapy prior to the first dose of study treatment 2) no evidence of CNS disease progression as determined by radiographic imaging ≥ 4 weeks prior to the first dose of study treatment, 3) ≥ 2 weeks from discontinuation of anti-seizure and steroid therapies (receiving prednisone ≤ 10 mg or equivalent steroid therapies is allowed) prior to the first dose of study treatment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RC220The assigned dose will be administered by intravenous infusion over 60 minutes. | Drug | Part 1: Dose Escalation, Part 2: Dose Expansion |
| Doxorubicin (Adriamycin)Also: Doxorubicin Hydrochloride, 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 | Drug | Part 1: Dose Escalation, Part 2: Dose Expansion |
Primary outcome
Part 1. Incidence of dose limiting toxicities (DLTs)
Time frame: During the first cycle of RC220 and doxorubicin treatment (1-21 days)
Evaluated at each dose level RC220 combined with doxorubicin, as graded by National Cancer Institute (NCI) Common Terminology for Adverse Events (CTCAE) version 5.0.
Part 1 and Part 2. Treatment emergent adverse events (TEAE) and serious adverse events (SAEs),
Time frame: First dose up to 30 days post last combination dose (up to 12 months)
This includes clinically significant changes in vital signs, physical examination, electrocardiogram, echocardiogram and clinical laboratory tests, as graded by NCI CTCAE v5.0.
8 secondary outcomes
Part 1. Maximum tolerated combined dose (MTCD)
Time frame: After the first dose of RC220 and doxorubicin treatment cycle (1-21 days)
Part 1 and Part 2. Best Overall Response (BOR)
Time frame: Up to 12 months
Part 1 and Part 2. Duration of Response (DOR)
Time frame: Up to 12 months
Part 1 and Part 2. Progression Free Survival (PFS)
Time frame: Up to 12 months
Part 2. Change from baseline in cardiac blood biomarker levels (hs-troponins and NT-proBNP), as measured by laboratory tests
Time frame: up to 12 months
Part 2. Change from baseline in 2D-echocardiogram measurements including GLS, LV volume, LV mass, transmitral flow, atrial volumes.
Time frame: Up to 12 months
Part 2. Change from baseline in cardiac magnetic resonance imaging (cMRI) cardiac function parameters (blood flow, global ventricular function, myocardial perfusion)
Time frame: Up to 12 months
Part 2. Change from baseline in functional volume of peak oxygen uptake (VO2 peak). Defined as the highest amount of oxygen consumed at peak exercise.
Time frame: Up to 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2026.
- Individual participant dataSharing planned: No. Due to the small sample size of this Phase 1 study, individual participant data will not be shared openly to protect participant confidentiality.
Related trials for Solid Tumours
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Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
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A Safety and Efficacy Extension Study of Pertuzumab in Patients With Solid Tumors Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Clinical Trial
Solid Tumors
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IL-12 Genetically Engineered Myeloid Cells in Participants With Relapsed, Refractory Solid Tumors
Relapsed Solid Tumor Malignancies, Refractory Solid Tumor Malignancies
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Immune Checkpoint Inhibitor Toxicity Risk Prediction in Solid Tumors
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Corli Merry contact
Marinella Messina study director
Racura Oncology Ltd
9 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing RC220 and Doxorubicin (Adriamycin) in people with Solid Tumours and Advanced Solid Tumours, run by Racura Oncology Ltd at 9 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 35 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in South Korea, Australia, Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marinella Messina (+61 480 258 306, marinella.messina@racuraoncology.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Part 1. Incidence of dose limiting toxicities (DLTs) (time frame: During the first cycle of RC220 and doxorubicin treatment (1-21 days)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2026.