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Clinical Trial Finder

Search Results

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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Abbreviated

Inclusion 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.Abbreviated

Exclusion Criteria:

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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04485013
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Tizona Therapeutics, Inc
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Cancer
Additional Details

TTX-080 is a fully human mAb designed to block the interaction of HLA-G with its known ligands, ILT2 and ILT4 molecules. The Phase 1a was an open label, multicenter, dose escalation clinical trial to determine the safety, tolerability, MTD or OBD, and the RP2D of TTX-080 when administered as a single agent. The Phase 1b is a dose expansion of TTX-080 monotherapy and in combination with either pembrolizumab or cetuximab in adult subjects with advanced refractory/resistant solid malignancies, including Head and Neck squamous cell carcinoma (HNSCC), Non-Small Cell Lung Cancer (NSCLC), Colorectal cancer (CRC), triple negative breast cancer (TNBC), renal cell carcinoma (RCC), and acral melanoma. Additionally, the Phase 1b includes randomized arms with TTX-080 in combination with FOLFIRI plus cetuximab compared to FOLFIRI plus cetuximab in metastatic Colorectal cancer. The study will seek to evaluate the pharmacokinetics and immunogenicity of TTX-080, and characterize the anti-tumor activity of TTX-080 as a monotherapy and in combination with pembrolizumab, cetuximab or FOLFIRI plus cetuximab.

Arms & Interventions

Arms

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.

Interventions

Drug: - TTX-080

Variable dose (Q3W)

Drug: - TTX-080

Specified dose (Q3W)

Drug: - pembrolizumab

Specified dose (Q3W)

Drug: - cetuximab

Specified dose on specified days

Drug: - FOLFIRI

Specified dose (Q2W)

Drug: - cetuximab

Specified dose (Q2W)

Drug: - TTX-080

Specified dose (Q2W)

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Arizona Oncology Associates, Tucson 5318313, Arizona 5551752

Status

Completed

Address

Arizona Oncology Associates

Tucson 5318313, Arizona 5551752, 85711

Site Contact

[email protected]

888-585-2990

University of Southern California, Los Angeles 5368361, California 5332921

Status

Completed

Address

University of Southern California

Los Angeles 5368361, California 5332921, 90033

Site Contact

[email protected]

888-585-2990

Hoag Memorial Hospital, Newport Beach 5376890, California 5332921

Status

Completed

Address

Hoag Memorial Hospital

Newport Beach 5376890, California 5332921, 92663

Site Contact

[email protected]

888-585-2990

Rocky Mountain Cancer Centers, Denver 5419384, Colorado 5417618

Status

Recruiting

Address

Rocky Mountain Cancer Centers

Denver 5419384, Colorado 5417618, 80218

Site Contact

[email protected]

303-388-4876

Yale Cancer Center, New Haven 4839366, Connecticut 4831725

Status

Recruiting

Address

Yale Cancer Center

New Haven 4839366, Connecticut 4831725, 06511

Site Contact

[email protected]

203-737-5342

Newark 4143861, Delaware 4142224

Status

Completed

Address

Christiana Care Helen F. Graham Cancer Center

Newark 4143861, Delaware 4142224, 19713

Site Contact

[email protected]

888-585-2990

John Hopkins Kimmer Cancer Center, Washington D.C. 4140963, District of Columbia 4138106

Status

Completed

Address

John Hopkins Kimmer Cancer Center

Washington D.C. 4140963, District of Columbia 4138106, 20016

Site Contact

[email protected]

888-585-2990

Florida Cancer Specialists, Daytona Beach 4152872, Florida 4155751

Status

Recruiting

Address

Florida Cancer Specialists

Daytona Beach 4152872, Florida 4155751, 32117

Site Contact

[email protected]

386-231-4060

Florida Cancer Specialists, Fleming Island 4155594, Florida 4155751

Status

Completed

Address

Florida Cancer Specialists

Fleming Island 4155594, Florida 4155751, 32003

Site Contact

[email protected]

888-585-2990

Ocala Oncology Center, Ocala 4166673, Florida 4155751

Status

Recruiting

Address

Ocala Oncology Center

Ocala 4166673, Florida 4155751, 34474

Site Contact

[email protected]

352-547-1958

AdventHealth Research Institute, Orlando 4167147, Florida 4155751

Status

Completed

Address

AdventHealth Research Institute

Orlando 4167147, Florida 4155751, 32804

Site Contact

[email protected]

888-585-2990

Illinois Cancer Specialists, Arlington Heights 4883555, Illinois 4896861

Status

Completed

Address

Illinois Cancer Specialists

Arlington Heights 4883555, Illinois 4896861, 60005

Site Contact

[email protected]

888-585-2990

University of Illinois, Chicago 4887398, Illinois 4896861

Status

Completed

Address

University of Illinois

Chicago 4887398, Illinois 4896861, 60612

Site Contact

[email protected]

888-585-2990

Indiana University, Indianapolis 4259418, Indiana 4921868

Status

Completed

Address

Indiana University

Indianapolis 4259418, Indiana 4921868, 46202

Site Contact

[email protected]

888-585-2990

Norton Cancer Institute, Louisville 4299276, Kentucky 6254925

Status

Completed

Address

Norton Cancer Institute

Louisville 4299276, Kentucky 6254925, 40241

Site Contact

[email protected]

888-585-2990

Maryland Oncology Hematology, Silver Spring 4369596, Maryland 4361885

Status

Recruiting

Address

Maryland Oncology Hematology

Silver Spring 4369596, Maryland 4361885, 20904

Site Contact

[email protected]

301-933-3216

Dana-Farber Cancer Institute, Boston 4930956, Massachusetts 6254926

Status

Recruiting

Address

Dana-Farber Cancer Institute

Boston 4930956, Massachusetts 6254926, 02215

Site Contact

[email protected]

617-582-8705

START Midwest, Grand Rapids 4994358, Michigan 5001836

Status

Completed

Address

START Midwest

Grand Rapids 4994358, Michigan 5001836, 49546

Site Contact

[email protected]

888-585-2990

Regions Hospital Cancer Care Center, Saint Paul 5045360, Minnesota 5037779

Status

Recruiting

Address

Regions Hospital Cancer Care Center

Saint Paul 5045360, Minnesota 5037779, 55101

Site Contact

[email protected]

651-254-3602

Washington University in St Louis, St Louis 4407066, Missouri 4398678

Status

Completed

Address

Washington University in St Louis

St Louis 4407066, Missouri 4398678, 63110

Site Contact

[email protected]

888-585-2990

Omaha 5074472, Nebraska 5073708

Status

Recruiting

Address

Nebraska Cancer Center Oncology Hematology West P.C.

Omaha 5074472, Nebraska 5073708, 68130

Site Contact

[email protected]

402-691-6971

Rutgers Cancer Institute of New Jersey, New Brunswick 5101717, New Jersey 5101760

Status

Recruiting

Address

Rutgers Cancer Institute of New Jersey

New Brunswick 5101717, New Jersey 5101760, 08903

Site Contact

[email protected]

732-235-3253

Icahn School of Medicine at Mount Sinai, New York 5128581, New York 5128638

Status

Completed

Address

Icahn School of Medicine at Mount Sinai

New York 5128581, New York 5128638, 10029

Site Contact

[email protected]

888-585-2990

Stony Brook University, Stony Brook 5139865, New York 5128638

Status

Completed

Address

Stony Brook University

Stony Brook 5139865, New York 5128638, 11794

Site Contact

[email protected]

888-585-2990

University of Cincinnati, Cincinnati 4508722, Ohio 5165418

Status

Recruiting

Address

University of Cincinnati

Cincinnati 4508722, Ohio 5165418, 45267

Site Contact

[email protected]

513-584-5680

Zangmeister Cancer Center, Columbus 4509177, Ohio 5165418

Status

Completed

Address

Zangmeister Cancer Center

Columbus 4509177, Ohio 5165418, 43219

Site Contact

[email protected]

888-585-2990

The University of Toledo, Toledo 5174035, Ohio 5165418

Status

Completed

Address

The University of Toledo

Toledo 5174035, Ohio 5165418, 43606

Site Contact

[email protected]

888-585-2990

University of Oklahoma, Oklahoma City 4544349, Oklahoma 4544379

Status

Recruiting

Address

University of Oklahoma

Oklahoma City 4544349, Oklahoma 4544379, 73104

Site Contact

[email protected]

405-271-8001 #32084

University of Pittsburgh Medical Center, Pittsburgh 5206379, Pennsylvania 6254927

Status

Completed

Address

University of Pittsburgh Medical Center

Pittsburgh 5206379, Pennsylvania 6254927, 15232

Site Contact

[email protected]

888-585-2990

Medical University of South Carolina, Charleston 4574324, South Carolina 4597040

Status

Completed

Address

Medical University of South Carolina

Charleston 4574324, South Carolina 4597040, 29425

Site Contact

[email protected]

888-585-2990

Sarah Cannon Research Institute, Nashville 4644585, Tennessee 4662168

Status

Recruiting

Address

Sarah Cannon Research Institute

Nashville 4644585, Tennessee 4662168, 37203

Site Contact

[email protected]

615-524-4203

Vanderbilt - Ingram Cancer Center, Nashville 4644585, Tennessee 4662168

Status

Completed

Address

Vanderbilt - Ingram Cancer Center

Nashville 4644585, Tennessee 4662168, 37232

Site Contact

[email protected]

888-585-2990

Texas Oncology - Dallas, Dallas 4684888, Texas 4736286

Status

Recruiting

Address

Texas Oncology - Dallas

Dallas 4684888, Texas 4736286, 75246

Site Contact

[email protected]

214-370-1000

Houston 4699066, Texas 4736286

Status

Completed

Address

The University of Texas MD Anderson Cancer Center

Houston 4699066, Texas 4736286, 77030

Site Contact

[email protected]

888-585-2990

Texas Oncology - Paris, Paris 4717560, Texas 4736286

Status

Recruiting

Address

Texas Oncology - Paris

Paris 4717560, Texas 4736286, 75460

Site Contact

[email protected]

903-785-0031

NEXT Oncology, San Antonio 4726206, Texas 4736286

Status

Completed

Address

NEXT Oncology

San Antonio 4726206, Texas 4736286, 78229

Site Contact

[email protected]

888-585-2990

NEXT Oncology Virginia, Fairfax 4758023, Virginia 6254928

Status

Recruiting

Address

NEXT Oncology Virginia

Fairfax 4758023, Virginia 6254928, 22031

Site Contact

[email protected]

703-280-5290

Northwest Medical Specialties, Tacoma 5812944, Washington 5815135

Status

Completed

Address

Northwest Medical Specialties

Tacoma 5812944, Washington 5815135, 98405

Site Contact

[email protected]

888-585-2990

Northwest Cancer Specialists, Vancouver 5814616, Washington 5815135

Status

Completed

Address

Northwest Cancer Specialists

Vancouver 5814616, Washington 5815135, 98684

Site Contact

[email protected]

888-585-2990

Resources

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The content provided on clinical trials is for informational purposes only and is not a substitute for medical consultation with your healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with your healthcare provider. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage individuals to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation.

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