Wyong

Researchers are evaluating the safety, tolerability, pharmacokinetics, and pharmacodynamics of RC220, a bisantrene formulation, alone and combined with doxorubicin in adults with advanced solid tumors where anthracycline treatment may be suitable. This phase 1, open-label, multi-center study aims to find the maximum tolerated dose of RC220 with doxorubicin and assess preliminary cardioprotective and anti-tumor effects in patients who have not previously received anthracyclines. The study has two parts: Part 1 involves dose escalation where patients receive intravenous RC220 alone on Day 1, then combined with doxorubicin (60 mg/m2 IV) on Day 1 of 21-day cycles, to establish the maximum tolerated combined dose. Part 2 is a dose expansion cohort where patients receive the determined maximum dose combination to further evaluate safety, tolerability, and early efficacy. Treatment continues until disease progression, unacceptable side effects, withdrawal, or study end. Participants will undergo safety and adverse event monitoring including dose limiting toxicities during the first 21-day treatment cycle and tracking of treatment-emergent and serious adverse events up to 30 days after the last dose, with follow-up potentially extending to 12 months. Researchers will assess tumor response per RECIST criteria and collect laboratory tests, imaging, and patient evaluations throughout the study to measure treatment effects and tolerability.