TTX-030 Single Agent and in Combination With Immunotherapy or Chemotherapy for Patients With Advanced Cancers

Phase 1

Completed

Interventions: Drug: TTX-030
Drug: Pembrolizumab
Drug: Gemcitabine
Drug: nab paclitaxel

Brief Summary: 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.

Recruitment & Eligibility

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arm && Interventions

Group	Intervention	Description
Arm 1, Single Agent	TTX-030	TTX-030
Arm 2, Anti-PD-1 Combination	TTX-030	TTX-030 plus pembrolizumab
Arm 4, Chemotherapy Combination	TTX-030	TTX-030 plus gemcitabine plus nab-paclitaxel
Arm 4, Chemotherapy Combination	nab paclitaxel	TTX-030 plus gemcitabine plus nab-paclitaxel
Arm 2, Anti-PD-1 Combination	Pembrolizumab	TTX-030 plus pembrolizumab
Arm 4, Chemotherapy Combination	Gemcitabine	TTX-030 plus gemcitabine plus nab-paclitaxel

Primary Outcome Measures

Name	Time	Method
Objective Response Rate (ORR) - Arm 1 and Arm 2 Expansion Cohorts	Through study completion, an average of 1 year	Anti-tumor activity in subjects treated with TTX-030 as single agent or in combination with specified regimens
Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs)	1 cycle (each cycle is 21-28 days)	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.

Secondary Outcome Measures

Name	Time	Method
Objective Response Rate (ORR) (Except for Arm 1 and 2 Expansion Cohorts, Where ORR Was a Primary Endpoint)	Through study completion, an average of 1 year	Anti-tumor activity in subjects treated with TTX-030 as single agent or in combination with specified regimens
Maximum Plasma Concentration (Cmax)	Cycles 1-3 (each cycle is 21-28 days)	PK parameters of serum TTX-030 by Arm and Dose - Cycle 1

Locations (16): 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
Montefiore Medical Center
🇺🇸
Bronx, New York, United States
Columbia University Irving Medical Center
🇺🇸
New York, New York, United States
Memorial Sloan Kettering Cancer Center
🇺🇸
New York, New York, United States
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UC Irvine Cancer Center
🇺🇸Orange, California, United States