Phase 1 Study of Intravenous RC220 With Doxorubicin to Assess Safety and Effects in Adults With Advanced Solid Tumors

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 MTCDs 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.

A Safety and Pharmacokinetics Study of RC220 Combined With Doxorubicin in Adult Participants With Solid Tumours.