Phase I Study of DXC006 Given Intravenously for Advanced Solid Tumors and Blood Cancers Evaluating Safety, Dosage, and Effectiveness

What this Trial Is About

Researchers are studying DXC006 in a phase I, open-label, first-in-human clinical trial involving patients with advanced solid tumors such as small cell lung cancer, multiple myeloma, neuroblastoma, and various hematological malignancies. The trial aims to assess the safety, tolerability, maximum tolerated dose MTD, dose limiting toxicities DLT, recommended phase 2 dose RP2D, pharmacokinetics, immunogenicity, and preliminary anti-tumor activity of DXC006. This study is sponsored by Hangzhou DAC Biotechnology Co., Ltd. and focuses on treatment outcomes for these cancer types. Participants receive DXC006 intravenously every two weeks during two main periods a dose escalation phase where dosing is adjusted according to cohort levels, and a dose expansion phase at the recommended dose. These study periods evaluate how the drug behaves in the body, its safety profile, and its potential anti-cancer effects. The study does not use masking or placebo controls and follows a sequential design. During the study, participants are monitored for dose limiting toxicities over 28 days and adverse events throughout approximately one year after the first infusion. Researchers collect blood samples and evaluate pharmacokinetic parameters, anti-drug antibodies, and tumor response measures including objective response rate, duration of response, progression-free survival, and overall survival. The total participation duration may last about a year, with ongoing safety and efficacy assessments.

A Study of DXC006 in Patients With Advanced Solid Tumors and Hematologic Malignancies