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

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.

Conditions

Cancer

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Cancer
Intervention / Treatment

-

Contacts and Locations

Tucson

Arizona Oncology Associates, Tucson, Arizona, United States, 85711

Los Angeles

University of Southern California, Los Angeles, California, United States, 90033

Newport Beach

Hoag Memorial Hospital, Newport Beach, California, United States, 92663

Denver

Rocky Mountain Cancer Centers, Denver, Colorado, United States, 80218

New Haven

Yale Cancer Center, New Haven, Connecticut, United States, 06511

Newark

Christiana Care Helen F. Graham Cancer Center, Newark, Delaware, United States, 19713

Washington

John Hopkins Kimmer Cancer Center, Washington, District of Columbia, United States, 20016

Daytona Beach

Florida Cancer Specialists, Daytona Beach, Florida, United States, 32117

Fleming Island

Florida Cancer Specialists, Fleming Island, Florida, United States, 32003

Ocala

Ocala Oncology Center, Ocala, Florida, United States, 34474

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

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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Tizona Therapeutics, Inc,

Study Record Dates

2027-06-01