Phase I Study of FS-8002 Alone and in Combination With Toripalimab and Chemotherapy for Advanced Solid Tumors

What this Trial Is About

Researchers are conducting an open, single-arm Phase I clinical trial to evaluate the safety, tolerability, pharmacokinetics, and preliminary effectiveness of FS-8002, alone and in combination with Toripalimab Injection and chemotherapy, in patients with advanced solid tumors. This study aims to better understand how these therapies work and their potential impact on patients who have not responded to or cannot tolerate standard treatments. Participants will receive FS-8002 injection every three weeks, either alone or combined with Toripalimab Injection, with some also receiving chemotherapy chosen by their doctor. Treatment continues until the patient experiences disease progression, unacceptable side effects, death, loss of follow-up, voluntary withdrawal, or the study ends. The study includes a dose escalation phase with six dose groups involving 42 patients to determine the best dose levels. Throughout the study, participants will be closely monitored with regular assessments of drug levels in the blood, side effects, and tumor responses using recognized criteria. Researchers will evaluate multiple outcomes including maximum tolerated dose, dose-limiting toxicities, adverse events, and various measures of tumor control and patient survival over one to two years. Participants will have ongoing evaluations during treatment and follow-up periods to track safety and effectiveness.

Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacokinetics, and Preliminary Efficacy of FS-8002