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BRIEF TITLE: Study to Evaluate the Safety of TTX-080, an HLA-G Antagonist, in Subjects With Advanced Solid Tumors

A First-in-human, Phase 1 Study to Evaluate the Safety of TTX-080, an HLA-G Antagonist, in Subjects With Advanced Solid Tumors


  • Org Study ID: TTX-080-001
  • Secondary ID:
  • NCT ID: NCT04485013
  • NCT Alias:
  • Sponsor: Tizona Therapeutics, Inc - Industry
  • Source: Tizona Therapeutics, Inc

Brief 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.

Overal Status Start Date Phase Study Type
Recruiting July 14, 2020 Phase 1 Interventional

Primary Outcomes:

Primary Outcome 1 - Measure: Recommended Phase 2 Dose (RP2D)

Primary Outcome 1 - Time Frame: 1 cycle (each cycle is 21 days)

Condition:

  • Solid Tumor, Adult

Eligibility

Criteria:
Abbreviated Inclusion Criteria:

1. Subject with histological or cytological diagnosis of advanced/metastatic cancer

2. Age 18 years or older, is willing and able to provide informed consent

3. Evidence of measurable disease
r/> 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1

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 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
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Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Contact

Name: Tizona Therapeutics, Inc.

Phone: 888-585-2990

Email: clinicaltrials@tizonatx.com

Locations

Facility Status Contact
Nebraska Cancer Center Oncology Hematology West P.C.
Omaha, Nebraska 68130
United States
Recruiting Megan Meays, M.A. CCRC
402-691-6971
mmeays@nebraskacancer.com
NEXT Oncology
San Antonio, Texas 78229
United States
Recruiting Sarah Gomez
210-580-9521
sgomez@nextsat.com