This is a phase 1/1b study of TTX-030, an antibody that inhibits CD39 enzymatic activity, leading to accumulation of pro-inflammatory adenosine triphosphate (ATP) and reduction of immunosuppressive adenosine, which may change the tumor microenvironment and promote anti-tumor immune response. This trial will study the safety, tolerability, pharmacokinetics, and anti-tumor activity of TTX-030 as a single agent and in combination with an approved anti-PD-1 immunotherapy and standard chemotherapies.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
56
Variable dose and schedule
Dose and schedule per standard of care
Dose and schedule per standard of care
Dose and schedule per standard of care
UC Irvine Cancer Center
Orange, California, United States
UC Davis Comprehensive Cancer Center
Sacramento, California, United States
University of California, San Francisco
San Francisco, California, United States
Sylvester Comprehensive Cancer Center
Miami, Florida, United States
Norton Cancer Institute
Louisville, Kentucky, United States
Nebraska Cancer Center Oncology Hematology West P.C.
Omaha, Nebraska, United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States
Columbia University Irving Medical Center
New York, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
...and 6 more locations
Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs)
A DLT was defined as any clinically significant AE that occurred during Treatment Cycle 1 that the Investigator or Sponsor considered as possibly or likely related to TTX-030 as a single agent, or the combination of TTX-030 and other agent(s), and met the following criteria: NCI CTCAE Version 5.0 Grade 5 event, Grade 4 hematological or Grade≥3 non-hematological toxicities, or Grade≥3 irAEs. Laboratory abnormalities that were asymptomatic and deemed not clinically significant were not regarded as DLTs. During Dose Escalation, each dosing cohort was completed through the DLT observation window before escalation was allowed within its arm. In each Safety Lead-in cohort, all participants were closely monitored for the occurrence of DLTs.
Time frame: 1 cycle (each cycle is 21-28 days)
Objective Response Rate (ORR) - Arm 1 and Arm 2 Expansion Cohorts
Anti-tumor activity in subjects treated with TTX-030 as single agent or in combination with specified regimens
Time frame: Through study completion, an average of 1 year
Objective Response Rate (ORR) (Except for Arm 1 and 2 Expansion Cohorts, Where ORR Was a Primary Endpoint)
Anti-tumor activity in subjects treated with TTX-030 as single agent or in combination with specified regimens
Time frame: Through study completion, an average of 1 year
Maximum Plasma Concentration (Cmax)
PK parameters of serum TTX-030 by Arm and Dose - Cycle 1
Time frame: Cycles 1-3 (each cycle is 21-28 days)
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