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 Outcome 1 - Measure: Recommended Phase 2 Dose (RP2D)
Primary Outcome 1 - Time Frame: 1 cycle (each cycle is 21 days)
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
Name: Tizona Therapeutics, Inc.
Phone: 888-585-2990
Email: clinicaltrials@tizonatx.com
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 |