Phase 1 Study to Evaluate Safety and Effectiveness of CS5001 Alone and with Other Treatments in Patients With Advanced Solid Tumors and Lymphomas

What this Trial Is About

Researchers are evaluating the safety and early effects of an experimental drug called CS5001 in people with advanced solid tumors and lymphomas. This study is a first-in-human trial, meaning it is the first time CS5001 is being tested in humans. The study aims to find safe dosage levels and observe how well the drug works alone or combined with other cancer treatments. Participants may receive CS5001 either alone or together with other systemic therapies such as Rituximab, Gemcitabine, Oxaliplatin, Lenalidomide, Cyclophosphamide, Doxorubicin, Vincristine, or Prednisone. The doses and schedules are determined by a safety committee. The study includes a dose escalation phase to find appropriate dosing, followed by a dose expansion phase to further evaluate the drugs effects. During the study, participants will be closely monitored for side effects and treatment responses using criteria specific to solid tumors and lymphomas. Researchers will assess the maximum tolerated dose, recommended dose for future studies, adverse events, and objective response rate up to two years. Blood tests will measure drug concentrations and antibody levels. Safety is followed until 90 days after the last dose or until new cancer treatments begin. The total duration of participation varies by individual treatment and response.

A Study of CS5001 in Patients With Advanced Solid Tumors and Lymphomas