Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 1:34 AM
Ignite Modification Date:
2025-12-25 @ 1:34 AM
NCT ID:
NCT06239194
Brief 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).
Study:
NCT06239194
Study Brief:
Protocol Section:
NCT06239194