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CancerPhase 1NCT04485013

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

A Phase 1 study testing TTX-080, pembrolizumab and cetuximab in people with Cancer, run by Tizona Therapeutics, Inc at 41 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cancer
What is being tested?
TTX-080, pembrolizumab and cetuximab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
240 participants
Where
41 sitesUnited States
Study dates
14 Jul 2020to 1 Jun 2027
Phase
Phase 1

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Abbreviated Inclusion Criteria:

  1. Subject with histological diagnosis of advanced/metastatic cancer [currently enrolling in CRC only]
  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 locations and contacts

41 sites in 1 country.

41 sites in 1 country

United States41 sites

  • Illinois Cancer Specialists

    Arlington Heights, Illinois, 60005

  • American Oncology Partners, P.A. - The Center for Cancer & Blood Disorders

    Bethesda, Maryland, 20817

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • University of Illinois

    Chicago, Illinois, 60612

  • University of Cincinnati

    Cincinnati, Ohio, 45267

  • Zangmeister Cancer Center

    Columbus, Ohio, 43219

  • Texas Oncology - Dallas

    Dallas, Texas, 75246

  • Florida Cancer Specialists

    Daytona Beach, Florida, 32117

  • Rocky Mountain Cancer Centers

    Denver, Colorado, 80218

  • NEXT Oncology Virginia

    Fairfax, Virginia, 22031

  • Florida Cancer Specialists

    Fleming Island, Florida, 32003

  • START Dallas

    Fort Worth, Texas, 76104

  • START Midwest

    Grand Rapids, Michigan, 49546

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030

  • Indiana University

    Indianapolis, Indiana, 46202

  • University of Southern California

    Los Angeles, California, 90033

  • Norton Cancer Institute

    Louisville, Kentucky, 40241

  • Sarah Cannon Research Institute

    Nashville, Tennessee, 37203

  • Vanderbilt - Ingram Cancer Center

    Nashville, Tennessee, 37232

  • Rutgers Cancer Institute of New Jersey

    New Brunswick, New Jersey, 08903

  • Yale Cancer Center

    New Haven, Connecticut, 06511

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029

  • Christiana Care Helen F. Graham Cancer Center

    Newark, Delaware, 19713

  • Hoag Memorial Hospital

    Newport Beach, California, 92663

  • Ocala Oncology Center

    Ocala, Florida, 34474

  • University of Oklahoma

    Oklahoma City, Oklahoma, 73104

  • Nebraska Cancer Center Oncology Hematology West P.C.

    Omaha, Nebraska, 68130

  • AdventHealth Research Institute

    Orlando, Florida, 32804

  • Texas Oncology - Paris

    Paris, Texas, 75460

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15232

  • Regions Hospital Cancer Care Center

    Saint Paul, Minnesota, 55101

  • NEXT Oncology

    San Antonio, Texas, 78229

  • Maryland Oncology Hematology

    Silver Spring, Maryland, 20904

  • Washington University in St Louis

    St Louis, Missouri, 63110

  • Stony Brook University

    Stony Brook, New York, 11794

  • Northwest Medical Specialties

    Tacoma, Washington, 98405

  • The University of Toledo

    Toledo, Ohio, 43606

  • Arizona Oncology Associates

    Tucson, Arizona, 85711

  • Northwest Cancer Specialists

    Vancouver, Washington, 98684

  • John Hopkins Kimmer Cancer Center

    Washington D.C., District of Columbia, 20016

Other trials in United States

About this study

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

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.

Read the detailed description

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. Only arm 9 and 10 are currently open to enrollment.

Conditions
Cancer
Being tested
TTX-080, pembrolizumab, cetuximab, FOLFIRI
Keywords
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
Medical subject headings
Neoplasms, Ovarian Neoplasms, Endometrial Neoplasms, Uterine Cervical Neoplasms, Kidney Neoplasms, Squamous Cell Carcinoma of Head and Neck, Prostatic Neoplasms, Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TTX-080Drug

    Variable dose (Q3W)

  • TTX-080Drug

    Specified dose (Q3W)

  • pembrolizumabDrug

    Specified dose (Q3W)

  • cetuximabDrug

    Specified dose on specified days

  • FOLFIRIDrug

    Specified dose (Q2W)

  • cetuximabDrug

    Specified dose (Q2W)

  • TTX-080Drug

    Specified dose (Q2W)

Study groups in NCT04485013
Study groupRoleWhat they receive
Phase 1a, Monotherapy Dose EscalationExperimentalNot described
Receives: Drug: TTX-080
Phase 1b, Dose Expansion: TTX-080 in combination with pembrolizumab (HNSCC)ExperimentalArm 1 will enroll subjects with advanced/metastatic, prior checkpoint inhibitor treated Head and Neck Squamous Cell Carcinoma (HNSCC) [Closed]
Receives: Drug: TTX-080; Drug: pembrolizumab
Phase 1b, Dose Expansion: TTX-080 in combination with cetuximab (HNSCC)ExperimentalArm 2 will enroll subjects with advanced/metastatic Head and Neck Squamous Cell Carcinoma (HNSCC) [Closed]
Receives: Drug: TTX-080; Drug: cetuximab
Phase 1b, Dose Expansion: TTX-080 monotherapy (CRC)ExperimentalArm 3 will enroll subjects with advanced/metastatic colorectal cancer (CRC) [Closed]
Receives: Drug: TTX-080
Phase 1b, Dose Expansion: TTX-080 in combination with cetuximab (CRC), prior anti-EGFR therapyExperimentalArm 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 [Closed]
Receives: Drug: TTX-080; Drug: cetuximab
Phase 1b, Dose Expansion: TTX-080 in combination with cetuximab (CRC), no prior anti-EGFR therapyExperimentalArm 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 [Closed]
Receives: Drug: TTX-080; Drug: cetuximab
Phase 1b, Dose Expansion: TTX-080 monotherapy (NSCLC)ExperimentalArm 6 will enroll subjects with advanced/metastatic non-small cell lung cancer (NSCLC) [Closed]
Receives: Drug: TTX-080
Phase 1b, Dose Expansion: TTX-080 in combination with pembrolizumab (NSCLC)ExperimentalArm 7 will enroll subjects with advanced/metastatic prior checkpoint inhibitor treated non-small cell lung cancer (NSCLC) [Closed]
Receives: Drug: TTX-080; Drug: pembrolizumab
Phase 1b, Dose Expansion: TTX-080 as monotherapy OR in combination with pembrolizumabExperimentalArm 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 [Closed]
Receives: Drug: TTX-080; Drug: pembrolizumab
TTX-080 in combination with FOLFIRI plus cetuximabExperimentalArm 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.
Receives: Drug: FOLFIRI; Drug: cetuximab; Drug: TTX-080
FOLFIRI plus cetuximabExperimentalArm 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.
Receives: Drug: FOLFIRI; Drug: cetuximab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 1. To determine the anti-tumor activity of TTX-080 by objective response rate [complete response + partial response) for each tumor arm per RECIST 1.1

    Measured: Up to 48 months

Secondary outcomes (9)

  1. Duration of Response, Progression Free Survival per RECIST 1.1

    Measured: Up to 48 months

  2. Overall Survival

    Measured: Up to 48 months

  3. Adverse events (AEs) as characterized by the incidence, type, frequency, severity (graded according to NCI-CTCAE v5.0), timing, seriousness, and relationship to investigational product, and/or combination therapy, and/or individual approved therapies

    Measured: Up to 48 months

  4. Tolerability: The number of cycles of TTX-080 received by patients before discontinuing due to unmanageable drug reactions

    Measured: Up to 48 months

  5. Serum levels of Anti Drug Antibody against TTX-080

    Measured: Up to 48 months

  6. Cmax: Maximum Observed Plasma Concentration for TTX-080

    Measured: Up to 48 months

  7. Tmax: Time to Reach the Cmax for TTX-080

    Measured: Up to 48 months

  8. AUC(0-t): Area Under the Plasma Concentration-time Curve From Zero Time to the Last Measurable Point for TTX-080

    Measured: Up to 48 months

  9. AUC(0-Inf): Area Under the Plasma Concentration-time Curve From Zero to Infinity for TTX-080

    Measured: Up to 48 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jul 2020
  2. Study start14 Jul 2020
  3. Primary completion1 Jun 2027 (estimated)
  4. Study completion1 Jun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
240 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04485013
Sponsor's protocol ID
TTX-080-001
Status last verified
Sep 2026
First submitted
15 Jul 2020
Last updated
11 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

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