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NCT Number: NCT04485013

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

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.

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Key information

Conditions

Cancer Adenocarcinoma Adenocarcinoma of Lung Adnexal Diseases Breast Diseases Breast Neoplasms Carcinoma Carcinoma, Renal Cell Carcinoma, Squamous Cell Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Endometrial Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gastrointestinal Diseases Gastrointestinal Neoplasms Genital Diseases Genital Diseases, Female Genital Diseases, Male Genital Neoplasms, Female Genital Neoplasms, Male Gonadal Disorders Head and Neck Neoplasms Intestinal Diseases Intestinal Neoplasms Kidney Diseases Kidney Neoplasms Lung Diseases Lung Neoplasms Male Urogenital Diseases Melanoma Neoplasm Metastasis Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplastic Processes Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Ovarian Diseases Ovarian Neoplasms Pathologic Processes Pathological Conditions, Signs and Symptoms Prostatic Diseases Prostatic Neoplasms Rectal Diseases Respiratory Tract Diseases Respiratory Tract Neoplasms Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases Squamous Cell Carcinoma of Head and Neck Stomach Diseases Stomach Neoplasms Thoracic Neoplasms Triple Negative Breast Neoplasms Urinary Bladder Diseases Urinary Bladder Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Arizona Oncology Associates, Tucson, Arizona, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Abbreviated Inclusion Criteria:

  • Subject with histological diagnosis of advanced/metastatic cancer [currently enrolling in CRC only]
  • 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

Abbreviated Exclusion Criteria:

  • History of allergy or hypersensitivity to study treatment components. Subjects with a history of severe hypersensitivity reaction to any monoclonal antibody
  • Use of an investigational agent within 28 days prior to the first dose of study treatment and throughout the study
  • Receiving high-dose systemic steroid therapy or any other form of immunosuppressive therapy
  • History of severe autoimmune disease
  • Uncontrolled intercurrent illness or other active malignancy requiring ongoing treatment

Treatment and study plan

TTX-080

Drug

Variable dose (Q3W)

Pembrolizumab

Drug

Specified dose (Q3W)

Cetuximab

Drug

Specified dose on specified days

FOLFIRI

Drug

Specified dose (Q2W)

Primary outcomes

  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

    Time frame: Up to 48 months

Secondary outcomes

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

    Time frame: Up to 48 months

  2. Overall Survival

    Time frame: 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

    Time frame: Up to 48 months

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

    Time frame: Up to 48 months

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

    Time frame: Up to 48 months

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

    Time frame: Up to 48 months

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

    Time frame: 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

    Time frame: Up to 48 months

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

    Time frame: Up to 48 months

Study contacts

Contact information is provided by the study sponsor or research team.

Tizona Therapeutics, Inc.

CONTACT

[email protected]

888-585-2990

Sponsors and collaborators

Lead sponsor

Tizona Therapeutics, Inc

Industry

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2027
Study completion
2027
First posted
Jul 24, 2020
Registry last updated
Feb 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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