SUPPORT HOTLINE (888) 901-2226
Donate Now

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
Show More

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
Yale Cancer Center
New Haven, Connecticut 06511
United States
Recruiting Ingrid Palma
203-737-5342
Ingrid.palma@yale.edu
Ocala Oncology Center
Ocala, Florida 34474
United States
Recruiting Sanjit Nirmalanandhan
352-547-1958
Sanjit.Nirmalanandhan@usoncology.com
Norton Cancer Institute
Louisville, Kentucky 40241
United States
Recruiting Kalyn Weaver

Kalyn.Weaver@nortonhealthcare.org
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
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey 08903
United States
Recruiting Elayne Wesolowsky
732-235-3253
wesoloel@cinj.rutgers.edu
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania 15232
United States
Recruiting Amy Rose
412-647-8587
kennaj@upmc.edu
Sarah Cannon Research Institute
Nashville, Tennessee 37203
United States
Recruiting Kate Dickinson
615-524-4203
kate.dickinson@sarahcannon.com
The University of Texas MD Anderson Cancer Center
Houston, Texas 77030
United States
Recruiting Lacey McQuinn

lmcquinn@mdanderson.org
NEXT Oncology
San Antonio, Texas 78229
United States
Recruiting Sarah Gomez
210-580-9521
sgomez@nextsat.com