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

Официальное название

A Phase 1/2a, Multicenter, First-in-human, Open-label Clinical Trial Evaluating MDX2001 Monotherapy in Patients With Advanced Solid Tumors

Обзор

This study is designed to characterize the safety, tolerability, and anti-tumor activity of MDX2001 in patients with advanced solid tumors.

Подробное описание

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).

Вмешательства

• Препарат MDX2001
  MDX2001 intravenous infusion

Первичные конечные точки

• All Phases: Adverse events (AEs) [Срок оценки: Baseline until end of study, up to approximately 9 months]
• Phase 1b and Phase 2a: Objective response rate of MDX2001 [Срок оценки: From date of enrollment until the end of treatment, up to approximately 6 months]
• Phase 1: Recommended Phase 2 dose (RP2D) [Срок оценки: Baseline until end of study, up to approximately 9 months]

Вторичные конечные точки (9)

• Phase 1a: Objective response rate of MDX2001 [Срок оценки: From date of enrollment until the end of treatment, up to approximately 6 months]
• All Phases: Duration of response (DOR) [Срок оценки: From date of enrollment until the end of treatment, up to approximately 6 months]
• All Phases: Time to response (TTR) [Срок оценки: From date of enrollment until the first documentation of response (CR or PR), approximately 4 months]
• All Phases: Disease control rate (DCR) [Срок оценки: From date of enrollment until the end of treatment, up to approximately 6 months]
• All Phases: Progression free survival (PFS) [Срок оценки: From date of enrollment until the end of treatment, up to approximately 6 months]
• All Phases: Pharmacokinetic Parameter Cmax of MDX2001 [Срок оценки: From date of enrollment until completion of the 6th cycle of treatment, up to approximately 6 months]
• All Phases: Pharmacokinetic parameter area under the curve (AUC(0-T)) of MDX2001 [Срок оценки: From date of enrollment until the completion of the 3rd cycle of treatment, up to approximately 3 months]
• All Phases: Evaluation of MDX2001 immunogenicity [Срок оценки: Baseline until end of study, up to approximately 9 months]
• All Phases: Correlation between tumor antigen expression and anti-tumor activity of MDX2001 [Срок оценки: Baseline until the end of treatment, up to approximately 6 months]

Критерии участия

Критерии включения

• Patients must be ≥ 18 years of age
• Histologically or cytologically confirmed diagnosis of metastatic solid tumors
• Eastern Cooperative Oncology Group (ECOG) performance status 0-1
• All patients should have at least 1 measurable disease per RECIST v1.1. An irradiated lesion can be considered measurable only if progression has been demonstrated on the irradiated lesion.
• All contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
• Adequate hematologic, hepatic and renal function
• Capable of giving signed informed consent

Критерии исключения

• Any clinically significant cardiac disease
• Unresolved toxicities from previous anticancer therapy
• Prior solid organ or hematologic transplant
• Known untreated, active, or uncontrolled brain metastases
• Known positivity with human immunodeficiency virus (HIV), known active hepatitis B or C, or uncontrolled chronic or ongoing infectiion requiring intravenous treatment.
• Receipt of a live-virus vaccination within 28 days of planned treatment start
• Patient not suitable for participation, whatever the reason, as judged by the Investigator, including medical or clinical conditions.
• Participation in a concurrent clinical study in the treatment period.
• Known hypersensitivity to MDX2001 or any of its ingredients
• Supplemental oxygen use for activities of daily living

The above information is not intended to contain all considerations relevant to the potential participation in a clinical trial.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Последовательный дизайн

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 6 центров

• Sarah Cannon Research Institute — Denver
• Sylvester Comprehensive Cancer Center - University of Miami Health System — Miami
• Massachusetts General Hospital — Boston
• Sarah Cannon Research Institute — Nashville
• MD Anderson Cancer Center — Houston
• NEXT Oncology — San Antonio

Публикации

• Dumbrava E, Minchom A, Henry J, Johnson M, Sommerhalder D, Merchan J, Heist R, Cabanas EG, Cotreau M, Goenaga AL, Burzyn D, Makris L, Culm K, Abbadessa G. MDX-2001-101 study protocol: a phase I/IIa, multicenter, first-in-human, open-label clinical trial evaluating MDX2001 monotherapy in patients with advanced solid tumors. Future Oncol. 2026 Feb;22(3):305-312. doi: 10.1080/14796694.2025.2610468. E PMID 41495607

Идентификаторы

NCT: NCT06239194 · MDX-2001-101

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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