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Tests treatment safety and results for Solid Tumours
Official title A Safety and Pharmacokinetics Study of RC220 Combined With Doxorubicin in Adult Participants With Solid Tumours.
ClinicalTrials.gov ID: NCT06815575
What this study is testing
What is RC220?
RC220 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for solid tumours.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- (For Part 1 and Part 2):
- 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...
- Life expectancy ≥ 3 months.
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
You likely can't join if
- (for Part 1 and Part 2):
- 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...
- 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...
- 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...
See the full eligibility criteria
Who can join
- (For Part 1 and Part 2):
- 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...
- Adequate haematological, liver, and kidney function as follows: a. 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. b. Hepatic function:
- Aspartate aminotransferase (AST), alanine aminotransferase (ALT) \< 3 × upper limit of normal (ULN) (≤5 × ULN if liver metastases or hepatic cell carcinoma (HCC)). c. Renal function:
- Serum creatinine \ 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...
- 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...
- 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 8. Histologically/cytologically confirmed solid tumours of any stage for which the patient has not received prior treatment...
- 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.
What rules you out
- (for Part 1 and Part 2):
- 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...
- 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...
- 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.
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Gosford, New South Wales, Australia
- Miranda, New South Wales, Australia
- Wyong, New South Wales, Australia
- Hong Kong, Hong Kong
- Shatin, Hong Kong
- Seoul, South Korea
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Gosford, New South Wales, Australia; Miranda, New South Wales, Australia; Wyong, New South Wales, Australia; Hong Kong, Hong Kong; Shatin, Hong Kong; Seoul, South Korea. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.