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

INTRODUCTION

  • Org Study ID: TTX-080-001
  • Secondary ID: N/A
  • NTC ID: NCT04485013
  • Sponsor: 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.


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

PRIMARY OUTCOMES

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

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

CONDITION

  • Solid Tumor
  • Adult

ELIGIBILITY


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

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

Gender: All

Minimum Age: N/A

Maximum Age: 18 Years

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: N/A

Role: N/A

Affiliation: N/A

Overall Contact

Name: N/A

Phone: 888-585-2990

Email: clinicaltrials@tizonatx.com

LOCATION

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

Kalyn.Weaver@nortonhealthcare.org
Facility: Dana-Farber Cancer Institute
Boston, Massachusetts 02215
United States
Status: Recruiting Contact:
Elizabeth Downey
617-582-8705
elizabethe_downey@dfci.harvard.edu
Facility: Nebraska Cancer Center Oncology Hematology West P.C.
Omaha, Nebraska 68130
United States
Status: Recruiting Contact:
Megan Meays, M.A. CCRC
402-691-6971
mmeays@nebraskacancer.com
Facility: Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey 08903
United States
Status: Recruiting Contact:
Elayne Wesolowsky
732-235-3253
wesoloel@cinj.rutgers.edu
Facility: University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania 15232
United States
Status: Recruiting Contact:
Amy Rose
412-647-8587
kennaj@upmc.edu
Facility: Sarah Cannon Research Institute
Nashville, Tennessee 37203
United States
Status: Recruiting Contact:
Kate Dickinson
615-524-4203
kate.dickinson@sarahcannon.com
Facility: The University of Texas MD Anderson Cancer Center
Houston, Texas 77030
United States
Status: Recruiting Contact:
Lacey McQuinn

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