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

Description

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

Conditions

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

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Study Overview

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Study Details

Study overview

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

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

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

Condition
Biliary Tract Cancer
Intervention / Treatment

-

Contacts and Locations

Denver

Sarah Cannon Research Institute, Denver, Colorado, United States, 80218

Nashville

Sarah Cannon Research Institute, Nashville, Tennessee, United States, 37203

Houston

MD Anderson Cancer Center, Houston, Texas, United States, 77030

San Antonio

NEXT Oncology, San Antonio, Texas, United States, 78229

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

ModeX Therapeutics, An OPKO Health Company,

Study Record Dates

2029-02