RECRUITING

TTX-080 HLA-G Antagonist in Subjects with Advanced Cancers

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

TTX-080-001 is a Phase 1, open label, dose escalation and dose expansion clinical study to determine the safety, tolerability, and recommended Phase 2 dose of TTX-080 monotherapy (HLA-G inhibitor) and in combination with either pembrolizumab (PD-1 inhibitor), cetuximab (EGFR inhibitor) or FOLFIRI plus cetuximab (EGFR inhibitor) in patients with advanced refractory / resistant solid malignancies including metastatic colorectal cancer (mCRC) patients.

Official Title

A Phase 1a/1b Dose Escalation/Expansion Study of TTX-080, an HLA-G Antagonist, As Monotherapy and in Combination with Pembrolizumab, Cetuximab or FOLFIRI Plus Cetuximab in Patients with Advanced Solid Refractory/Resistant Malignancies

Quick Facts

Study Start:2020-07-14
Study Completion:2027-06-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04485013

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. 1. Subject with histological diagnosis of advanced/metastatic cancer
  2. 2. Age 18 years or older, is willing and able to provide informed consent
  3. 3. Evidence of measurable disease
  4. 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 AND life expectancy of at least 12 weeks
  1. 1. History of allergy or hypersensitivity to study treatment components. Subjects with a history of severe hypersensitivity reaction to any monoclonal antibody
  2. 2. Use of an investigational agent within 28 days prior to the first dose of study treatment and throughout the study
  3. 3. Receiving high-dose systemic steroid therapy or any other form of immunosuppressive therapy
  4. 4. History of severe autoimmune disease
  5. 5. Uncontrolled intercurrent illness or other active malignancy requiring ongoing treatment

Contacts and Locations

Study Contact

Tizona Therapeutics, Inc.
CONTACT
888-585-2990
clinicaltrials@tizonatx.com

Study Locations (Sites)

Arizona Oncology Associates
Tucson, Arizona, 85711
United States
University of Southern California
Los Angeles, California, 90033
United States
Hoag Memorial Hospital
Newport Beach, California, 92663
United States
Rocky Mountain Cancer Centers
Denver, Colorado, 80218
United States
Yale Cancer Center
New Haven, Connecticut, 06511
United States
Christiana Care Helen F. Graham Cancer Center
Newark, Delaware, 19713
United States
John Hopkins Kimmer Cancer Center
Washington, District of Columbia, 20016
United States
Florida Cancer Specialists
Daytona Beach, Florida, 32117
United States
Florida Cancer Specialists
Fleming Island, Florida, 32003
United States
Ocala Oncology Center
Ocala, Florida, 34474
United States
AdventHealth Research Institute
Orlando, Florida, 32804
United States
Illinois Cancer Specialists
Arlington Heights, Illinois, 60005
United States
University of Illinois
Chicago, Illinois, 60612
United States
Indiana University
Indianapolis, Indiana, 46202
United States
Norton Cancer Institute
Louisville, Kentucky, 40241
United States
Maryland Oncology Hematology
Silver Spring, Maryland, 20904
United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
United States
START Midwest
Grand Rapids, Michigan, 49546
United States
Regions Hospital Cancer Care Center
Saint Paul, Minnesota, 55101
United States
Washington University in St Louis
Saint Louis, Missouri, 63110
United States
Nebraska Cancer Center Oncology Hematology West P.C.
Omaha, Nebraska, 68130
United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903
United States
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
United States
Stony Brook University
Stony Brook, New York, 11794
United States
University of Cincinnati
Cincinnati, Ohio, 45267
United States
Zangmeister Cancer Center
Columbus, Ohio, 43219
United States
The University of Toledo
Toledo, Ohio, 43606
United States
University of Oklahoma
Oklahoma City, Oklahoma, 73104
United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15232
United States
Medical University of South Carolina
Charleston, South Carolina, 29425
United States
Sarah Cannon Research Institute
Nashville, Tennessee, 37203
United States
Vanderbilt - Ingram Cancer Center
Nashville, Tennessee, 37232
United States
Texas Oncology - Dallas
Dallas, Texas, 75246
United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
United States
Texas Oncology - Paris
Paris, Texas, 75460
United States
NEXT Oncology
San Antonio, Texas, 78229
United States
NEXT Oncology Virginia
Fairfax, Virginia, 22031
United States
Northwest Medical Specialties
Tacoma, Washington, 98405
United States
Northwest Cancer Specialists
Vancouver, Washington, 98684
United States

Collaborators and Investigators

Sponsor: Tizona Therapeutics, Inc

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 Date2020-07-14
Study Completion Date2027-06-01

Study Record Updates

Study Start Date2020-07-14
Study Completion Date2027-06-01

Terms related to this study

Keywords Provided by Researchers

  • HLA-G
  • TTX-080
  • Advanced Solid Tumor
  • Cancer
  • Ovarian Cancer
  • Endometrial Cancer
  • Cervical Cancer
  • Kidney Cancer
  • Head and Neck Squamous Cell Carcinoma
  • Squamous Cell Lung Cancer
  • Prostate Cancer
  • Colorectal Cancer
  • Gastric Cancer
  • Breast Cancer
  • Bladder Cancer
  • Lung Adenocarcinoma
  • Melanoma
  • Metastatic Solid Tumor
  • Renal cell carcinoma
  • Acral melanoma
  • Triple Negative Breast Cancer
  • Pembrolizumab
  • Cetuximab
  • Antineoplastic Agents, Immunological
  • Antineoplastic Agents
  • Head and Neck Cancer
  • Lung Cancer

Additional Relevant MeSH Terms

  • Cancer