Dose Escalation and Dose Expansion Study of MDX2001 in Patients With Advanced Solid Tumors
Start Date
6/12/2024
Completion Date
2/1/2029
Summary
This study is designed to characterize the safety, tolerability, and anti-tumor activity of MDX2001 in patients with advanced solid tumors.
Detailed Description
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).
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
MDX2001
Conditions
Locations
Sarah Cannon Research Institute
Denver, Colorado 80218
United States
Sylvester Comprehensive Cancer Center - University of Miami Health System
Miami, Florida 33136
United States
Massachusetts General Hospital
Boston, Massachusetts 02114
United States
Sarah Cannon Research Institute
Nashville, Tennessee 37203
United States
MD Anderson Cancer Center
Houston, Texas 77030
United States
NEXT Oncology
San Antonio, Texas 78229
United States