A Phase 1/2a, Open-label Study Evaluating MDX2001 Monotherapy in Patients With Advanced Solid Tumors

What this Trial Is About

Researchers are evaluating MDX2001, an investigational drug, for its safety, tolerability, and anti-tumor effects in patients with advanced solid tumors. This trial includes Phase 1a dose escalation, Phase 1b dose expansion focusing on a single tumor type, and Phase 2a expansion in a single tumor type. The study aims to find the recommended dose for further development and assess how well MDX2001 works against certain cancers. Participants receive MDX2001 through intravenous infusion. The trial has several parts: first, the dose is gradually increased to identify a safe level (Phase 1a). Then, patients with a specific tumor type receive the drug at optimized doses (Phase 1b and Phase 2a). Treatment duration varies, with an expected median of six months of therapy, plus about one month for screening and three months for follow-up. During the study, patients undergo regular assessments including safety monitoring for adverse events, tumor response evaluations, and laboratory tests to measure drug levels and immune response. Researchers will also examine the relationship between tumor protein expression and treatment benefit. The entire participation period may last up to about ten months. Safety and efficacy data will be collected throughout treatment and follow-up.

Dose Escalation and Dose Expansion Study of MDX2001 in Patients With Advanced Solid Tumors