Phase I Study to Assess Safety, Dosage, and Early Effects of DXC008 in Adults With Prostate Cancer and Other Solid Tumors Including Ewing Sarcoma

What this Trial Is About

Researchers are evaluating DXC008 in a phase I, open-label, first-in-human clinical trial to study its safety, tolerability, maximum tolerated dose, dose-limiting toxicities, recommended dose for further studies, pharmacokinetics, preliminary anti-tumor activity, and immune response in patients with prostate cancer and other solid tumors like Ewing sarcoma. The study aims to understand how DXC008 behaves in the body and its initial effects on tumors. Participants receive DXC008 in two dosing schedules one group receives the drug once every two weeks in 14-day cycles, and another group receives it once every three weeks in 21-day cycles. This dose escalation and expansion study is designed to carefully monitor patients as the dose is increased to find appropriate levels for safety and effectiveness. The study is open-label, meaning participants and researchers know the treatment being given. Throughout the trial, participants undergo regular assessments including monitoring for dose-limiting toxicities and adverse events over an average of one year following the first infusion. Researchers also measure drug levels in the blood, tumor response using recognized criteria, and immune reactions. Safety and clinical responses are tracked closely with imaging and laboratory tests. The total participation duration can extend up to about one year after enrollment depending on individual responses and study procedures.

A Study of DXC008 in Patients With Prostate Cancer and Other Solid Tumors