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NCT06239194 | RECRUITING | Biliary Tract Cancer

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

ModeX Therapeutics, An OPKO Health Company

Brief Summary:

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

Condition or disease

Biliary Tract Cancer

Breast Cancer

Cervical Cancer

Colon Cancer

Endometrial Cancer

Esophageal Cancer

Gastric Cancer

GastroEsophageal Cancer

Head and Neck Cancer

Hepatocellular Cancer

Non-small Cell Lung Cancer

Pancreatic Cancer

Prostate Cancer

Rectal Cancer

Renal Cancer

Thyroid Cancer

Intervention/treatment

MDX2001

Phase

PHASE1

PHASE2

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 Type : INTERVENTIONAL
Estimated Enrollment : 115 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : A Phase 1/2a, Multicenter, First-in-human, Open-label Clinical Trial Evaluating MDX2001 Monotherapy in Patients With Advanced Solid Tumors
Actual Study Start Date : 2024-06-12
Estimated Primary Completion Date : 2028-08
Estimated Study Completion Date : 2029-02

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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 infectious 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
  • The above information is not intended to contain all considerations relevant to the potential participation in a clinical trial.
Dose Escalation and Dose Expansion Study of MDX2001 in Patients With Advanced Solid Tumors

Location Details

NCT06239194

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Colorado

Sarah Cannon Research Institute

Denver, Colorado, United States, 80218

RECRUITING

United States, Florida

Sylvester Comprehensive Cancer Center - University of Miami Health System

Miami, Florida, United States, 33136

RECRUITING

United States, Tennessee

Sarah Cannon Research Institute

Nashville, Tennessee, United States, 37203

RECRUITING

United States, Texas

MD Anderson Cancer Center

Houston, Texas, United States, 77030

RECRUITING

United States, Texas

NEXT Oncology

San Antonio, Texas, United States, 78229