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Recruiting NCT06239194

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

Phase I / Phase II Interventional Biliary Tract Cancer Breast Cancer Cervical Cancer Colon Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: MDX2001.
Who it may be relevant to
Registry conditions: Biliary Tract Cancer, Breast Cancer, Cervical Cancer, Colon Cancer. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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).

Interventions

  • Drug MDX2001
    MDX2001 intravenous infusion

Primary outcome measures

  • All Phases: Adverse events (AEs) [Time frame: Baseline until end of study, up to approximately 9 months]
  • Phase 1b and Phase 2a: Objective response rate of MDX2001 [Time frame: From date of enrollment until the end of treatment, up to approximately 6 months]
  • Phase 1: Recommended Phase 2 dose (RP2D) [Time frame: Baseline until end of study, up to approximately 9 months]
Secondary outcome measures (9)
  • Phase 1a: Objective response rate of MDX2001 [Time frame: From date of enrollment until the end of treatment, up to approximately 6 months]
  • All Phases: Duration of response (DOR) [Time frame: From date of enrollment until the end of treatment, up to approximately 6 months]
  • All Phases: Time to response (TTR) [Time frame: From date of enrollment until the first documentation of response (CR or PR), approximately 4 months]
  • All Phases: Disease control rate (DCR) [Time frame: From date of enrollment until the end of treatment, up to approximately 6 months]
  • All Phases: Progression free survival (PFS) [Time frame: From date of enrollment until the end of treatment, up to approximately 6 months]
  • All Phases: Pharmacokinetic Parameter Cmax of MDX2001 [Time frame: 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 [Time frame: From date of enrollment until the completion of the 3rd cycle of treatment, up to approximately 3 months]
  • All Phases: Evaluation of MDX2001 immunogenicity [Time frame: Baseline until end of study, up to approximately 9 months]
  • All Phases: Correlation between tumor antigen expression and anti-tumor activity of MDX2001 [Time frame: Baseline until the end of treatment, up to approximately 6 months]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Sequential
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 6 centers
  • 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

Publications

  • 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

Identifiers

NCT: NCT06239194 · MDX-2001-101

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗