Breast Cancer Clinical Trial
Official title:
A Phase 1/2a, Multicenter, First-in-human, Open-label Clinical Trial Evaluating MDX2001 Monotherapy in Patients With Advanced Solid Tumors
This study is designed to characterize the safety, tolerability, and anti-tumor activity of MDX2001 in patients with advanced solid tumors.
This study consists of Phase 1a dose escalation, Phase 1b dose expansion in a single indication, and Phase 2a expansion in a single indication. Primary Objectives - All Phases: Evaluate the safety and tolerability of MDX2001 in patients with advanced solid tumor malignancies - Phase 1 only: Identify a recommended Phase 2 dose (RP2D) for further development of MDX2001 - For Phase 1b and Phase 2: Assess the anti-tumor efficacy of MDX2001 in patients with selected advanced solid tumor malignancies Secondary Objectives: - Further characterize the anti-tumor activity of MDX2001 based on additional assessments of clinical benefit - Characterize the pharmacokinetics of MDX2001 - Characterize the immunogenicity of MDX2001 - Characterize relationship of baseline target protein expression in tumor tissue and clinical benefit The expected duration of study intervention for patients may vary, based on progression date. The median expected duration of study per patient is estimated to be 10 months (up to 1 month for screening, a median of 6 months for treatment, and a median of 3 months for long term follow-up). ;
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