Phase Ib Study of HC010 Combined With Chemotherapy for Advanced Lung Cancer Evaluating Safety, Tolerability, and Effectiveness

What this Trial Is About

Researchers are evaluating the safety, tolerability, pharmacokinetics, and preliminary efficacy of a drug called HC010 combined with standard chemotherapy treatments in patients with advanced lung cancer. This Phase Ib, multicenter, open-label study aims to find the recommended dose for future research and includes patients with advanced solid tumors that cannot be treated with surgery or radiotherapy. The study focuses on lung cancer populations, including non-small cell lung cancer NSCLC and small cell lung cancer, with specific genetic mutation considerations. Participants receive HC010 through an intravenous drip every three weeks combined with chemotherapy regimens commonly used in clinical practice. These regimens include combinations with drugs such as Docetaxel, Paclitaxel, Carboplatin, Cisplatin, Pemetrexed, and Etoposide. The study includes a dose range-finding stage without tumor type restrictions and a dose-expansion stage focusing on specific lung cancer groups. There is no placebo or randomization all participants receive HC010 with chemotherapy. Throughout the trial, participants will have their response to treatment assessed using standard cancer evaluation criteria RECIST 1.1 over up to two years. Researchers will monitor dose-limiting toxicities within the first 21 days, measure drug levels in the blood, check for immune reactions to HC010, and record any adverse events. Participants must have adequate organ function and an estimated survival of more than three months. The study involves regular assessments to evaluate treatment effects and safety during the treatment period and follow-up.

A Phase Ib Clinical Study on the Safety and Efficacy of HC010 Combined With Chemotherapy in Lung Cancer