RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2024-06-12
Study Completion:2029-02
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06239194

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Patients must be ≥ 18 years of age
  2. * Histologically or cytologically confirmed diagnosis of metastatic solid tumors
  3. * Eastern Cooperative Oncology Group (ECOG) performance status 0-1
  4. * 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.
  5. * All contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
  6. * Adequate hematologic, hepatic and renal function
  7. * Capable of giving signed informed consent
  1. * Any clinically significant cardiac disease
  2. * Unresolved toxicities from previous anticancer therapy
  3. * Prior solid organ or hematologic transplant
  4. * Known untreated, active, or uncontrolled brain metastases
  5. * Known positivity with human immunodeficiency virus (HIV), known active hepatitis B or C, or uncontrolled chronic or ongoing infectious requiring intravenous treatment.
  6. * Receipt of a live-virus vaccination within 28 days of planned treatment start
  7. * Patient not suitable for participation, whatever the reason, as judged by the Investigator, including medical or clinical conditions.
  8. * Participation in a concurrent clinical study in the treatment period.
  9. * Known hypersensitivity to MDX2001 or any of its ingredients

Contacts and Locations

Study Contact

Email recommended
CONTACT
(857) 233-9936
info@modextx.com

Study Locations (Sites)

Sarah Cannon Research Institute
Denver, Colorado, 80218
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

Collaborators and Investigators

Sponsor: ModeX Therapeutics, An OPKO Health Company

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-06-12
Study Completion Date2029-02

Study Record Updates

Study Start Date2024-06-12
Study Completion Date2029-02

Terms related to this study

Additional Relevant MeSH Terms

  • 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