A Safety and Pharmacokinetics Study of RC220 Combined With Doxorubicin in Adult Participants With Solid Tumours.
Trial Parameters
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Brief 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.
Eligibility Criteria
Inclusion Criteria (For Part 1 and Part 2): 1. Able to give voluntary informed consent and understand the study and are willing to follow and complete all the study required procedures. 2. Aged ≥ 18 years at the time of informed consent. 3. Life expectancy ≥ 3 months. 4. 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. 5. Adequate haematological, liver, and kidney function as follows: 1. 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. 2. Hepatic function: * Aspartate aminotransferase (AST), alanine aminotransferase (ALT)