A Phase Ia/Ib 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

Study Identifier:
TTX-080-001
CT.gov Identifier:
NCT04485013
EudraCT Identifier:
N/A
EU Trial (CTIS) Number:
N/A
Study Contact Information:
(210) 593-5651 or [email protected]
Recruiting

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Study Summary

To evaluate TTX-080 in patients with advanced cancers.

To evaluate the safety, tolerability, PK, and pharmacodynamics of TTX-080 monotherapy in subjects with advanced or metastatic solid tumors known to express HLA-G.

Phase Ia: To determine the safety, tolerability, MTD or OBD and the RP2D of TTX-080 when administered as a single agent.

Phase Ib: 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), and triple negative breast cancer (TNBC).

To evaluate TTX-080, a First-in-Class HLA-G Antagonist, in Combination with Cetuximab in Patients with Metastatic Colorectal Cancer and Head and Neck Squamous Cell Carcinoma.

To evaluate safety, tolerability, recommended Phase 2 dose and preliminary efficacy of TTX-080 as monotherapy and in combination with either cetuximab, an EGFR inhibitor, or pembrolizumab, a PD-1 inhibitor, in patients with advanced refractory/resistant solid tumors

Patients were followed for safety and anti-tumor activity. Biopsies and blood samples were collected for biomarker analyses.

To evaluate either TTX-080 plus cetuximab and FOLFIRI or cetuximab and FOLFIRI alone in patients who have previously received 5-FU and oxaliplatin in the front-line or adjuvant setting (relapse within 6 months).

Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
  • Unspecified Cancer
    • Phase
    The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
    I
    Sex
    Female & Male
    Age
    18+ years
    Study Drug
  • Drug: Experimental:
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  • Drug: Experimental: Phase 1b, Dose Expansion: TTX-080 in combination with pembrolizumab (NSCLC)
    • Study Status
    Indicates the current recruitment status or the expanded access status
    Recruiting

    Requirements information
    Inclusion criteria
    • 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
    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

    Clinical Study Information for Healthcare Providers

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    Study Locations

    Location
    Investigator
    Status
    Condition(s) Treated at Site
    Location
    START Dallas Fort Worth
    Fort Worth, TX, United States, 76104
    Investigator
    Henry Xiong
    Status
    Recruiting
    Condition(s) Treated at Site
    Unspecified Cancer
    Location
    START Midwest
    Grand Rapids, MI, United States, 49546
    Investigator
    Sreenivasa Chandana
    Status
    Recruiting
    Condition(s) Treated at Site
    Unspecified Cancer