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
Who is this study for? Adult patients with Unresectable or Metastatic Solid Tumors that express HLA-G
What treatments are being studied? TTX-080
Status: Recruiting
Location: See all (39) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Subject with histological diagnosis of advanced/metastatic cancer
• Age 18 years or older, is willing and able to provide informed consent
• Evidence of measurable disease
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 AND life expectancy of at least 12 weeks
Locations
United States
Arizona
Arizona Oncology Associates
COMPLETED
Tucson
California
University of Southern California
COMPLETED
Los Angeles
Hoag Memorial Hospital
COMPLETED
Newport Beach
Colorado
Rocky Mountain Cancer Centers
RECRUITING
Denver
Connecticut
Yale Cancer Center
COMPLETED
New Haven
Washington, D.c.
John Hopkins Kimmer Cancer Center
COMPLETED
Washington D.c.
Delaware
Christiana Care Helen F. Graham Cancer Center
COMPLETED
Newark
Florida
Florida Cancer Specialists
RECRUITING
Daytona Beach
Florida Cancer Specialists
COMPLETED
Fleming Island
Ocala Oncology Center
RECRUITING
Ocala
AdventHealth Research Institute
COMPLETED
Orlando
Illinois
Illinois Cancer Specialists
COMPLETED
Arlington Heights
University of Illinois
COMPLETED
Chicago
Indiana
Indiana University
COMPLETED
Indianapolis
Kentucky
Norton Cancer Institute
COMPLETED
Louisville
Massachusetts
Dana-Farber Cancer Institute
RECRUITING
Boston
Maryland
Maryland Oncology Hematology
RECRUITING
Silver Spring
Michigan
START Midwest
COMPLETED
Grand Rapids
Minnesota
Regions Hospital Cancer Care Center
RECRUITING
Saint Paul
Missouri
Washington University in St Louis
COMPLETED
St Louis
Nebraska
Nebraska Cancer Center Oncology Hematology West P.C.
RECRUITING
Omaha
New Jersey
Rutgers Cancer Institute of New Jersey
RECRUITING
New Brunswick
New York
Icahn School of Medicine at Mount Sinai
COMPLETED
New York
Stony Brook University
COMPLETED
Stony Brook
Ohio
University of Cincinnati
RECRUITING
Cincinnati
Zangmeister Cancer Center
COMPLETED
Columbus
The University of Toledo
COMPLETED
Toledo
Oklahoma
University of Oklahoma
RECRUITING
Oklahoma City
Pennsylvania
University of Pittsburgh Medical Center
COMPLETED
Pittsburgh
South Carolina
Medical University of South Carolina
COMPLETED
Charleston
Tennessee
Sarah Cannon Research Institute
RECRUITING
Nashville
Vanderbilt - Ingram Cancer Center
COMPLETED
Nashville
Texas
Texas Oncology - Dallas
RECRUITING
Dallas
The University of Texas MD Anderson Cancer Center
COMPLETED
Houston
Texas Oncology - Paris
RECRUITING
Paris
NEXT Oncology
COMPLETED
San Antonio
Virginia
NEXT Oncology Virginia
RECRUITING
Fairfax
Washington
Northwest Medical Specialties
COMPLETED
Tacoma
Northwest Cancer Specialists
COMPLETED
Vancouver
Contact Information
Primary
Tizona Therapeutics, Inc.
clinicaltrials@tizonatx.com
888-585-2990
Time Frame
Start Date: 2020-07-14
Estimated Completion Date: 2027-06-01
Participants
Target number of participants: 240
Treatments
Experimental: Phase 1a, Monotherapy Dose Escalation
Experimental: Phase 1b, Dose Expansion: TTX-080 in combination with pembrolizumab (HNSCC)
Arm 1 will enroll subjects with advanced/metastatic, prior checkpoint inhibitor treated Head and Neck Squamous Cell Carcinoma (HNSCC)
Experimental: Phase 1b, Dose Expansion: TTX-080 in combination with cetuximab (HNSCC)
Arm 2 will enroll subjects with advanced/metastatic Head and Neck Squamous Cell Carcinoma (HNSCC)
Experimental: Phase 1b, Dose Expansion: TTX-080 monotherapy (CRC)
Arm 3 will enroll subjects with advanced/metastatic colorectal cancer (CRC)
Experimental: Phase 1b, Dose Expansion: TTX-080 in combination with cetuximab (CRC), prior anti-EGFR therapy
Arm 4 will enroll subjects with advanced/metastatic MSI-L/MSS, KRAS wild-type colorectal cancer (CRC) who have progressed on a prior anti-EGFR therapy
Experimental: Phase 1b, Dose Expansion: TTX-080 in combination with cetuximab (CRC), no prior anti-EGFR therapy
Arm 5 will enroll subjects with advanced/metastatic MSI-L/MSS, KRAS wild type colorectal cancer (CRC) who have not received a prior anti-EGFR therapy
Experimental: Phase 1b, Dose Expansion: TTX-080 monotherapy (NSCLC)
Arm 6 will enroll subjects with advanced/metastatic non-small cell lung cancer (NSCLC)
Experimental: Phase 1b, Dose Expansion: TTX-080 in combination with pembrolizumab (NSCLC)
Arm 7 will enroll subjects with advanced/metastatic prior checkpoint inhibitor treated non-small cell lung cancer (NSCLC)
Experimental: Phase 1b, Dose Expansion: TTX-080 as monotherapy OR in combination with pembrolizumab
Arm 8: TTX-080 monotherapy:~* Advanced/metastatic, prior checkpoint inhibitor treated renal cell carcinoma with predominance of clear cell component~* Advanced/metastatic acral melanoma~Arm 8: TTX-080 in combination with pembrolizumab:~• Advanced/metastatic triple-negative breast cancer (estrogen and progesterone receptor negative and HER2 negative) who has received a prior checkpoint inhibitor
Experimental: TTX-080 in combination with FOLFIRI plus cetuximab
Arm 9: TTX-080 in combination with FOLFIRI plus cetuximab Randomized Arms in subjects with metastatic RAS, BRAF and HER2 wild type colorectal cancer (CRC) who have been received oxaliplatin and 5-FU based chemotherapy in the first line or adjuvant (relapse within 6 months) setting. Prior bevacizumab allowed. No prior EGFR inhibitor.
Experimental: FOLFIRI plus cetuximab
Arm 10: FOLFIRI plus cetuximab Randomized Arms in subjects with metastatic RAS, BRAF and HER2 wild type colorectal cancer (CRC) who have been received oxaliplatin and 5-FU based chemotherapy in the first line or adjuvant (relapse within 6 months) setting. Prior bevacizumab allowed. No prior EGFR inhibitor.
Related Therapeutic Areas
Sponsors
Leads: Tizona Therapeutics, Inc