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

  • STATUS
    Recruiting
  • participants needed
    40
  • sponsor
    Tizona Therapeutics, Inc
Updated on 19 February 2024
cancer
measurable disease
metastasis
solid tumour
hla-g

Summary

This is a Phase 1, multicenter, open-label, multiple-dose, dose-escalation and dose-expansion study 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.

This first-in-human (FIH) study has been designed to evaluate the safety, tolerability, and preliminary antitumor activity of TTX-080 as monotherapy in adults with unresectable or metastatic solid tumors known to express HLA-G.

Details
Condition Solid Tumor, Adult
Age 18-100 years
Treatment TTX-080
Clinical Study IdentifierNCT04485013
SponsorTizona Therapeutics, Inc
Last Modified on19 February 2024

Eligibility

Yes No Not Sure

Inclusion Criteria

Subject with histological or cytological 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

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 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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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