TTX-030 Single Agent and in Combination With Immunotherapy or Chemotherapy for Patients With Advanced Cancers
Primary Purpose
Solid Tumor, Lymphoma
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
TTX-030
Pembrolizumab
Gemcitabine
nab paclitaxel
Sponsored by

About this trial
This is an interventional treatment trial for Solid Tumor focused on measuring Cancer, Metastatic Solid Tumors, Advanced Solid Tumors, Relapsed/Refractory Lymphoma, Prostrate Cancer, Pancreatic Cancer, Monotherapy, Combination Therapy, CD39, Adenosine Pathway, Immunotherapy, Immuno-oncology, PD-1, Checkpoint Inhibitor, Nab-paclitaxel, Gemcitabine, Pembrolizumab, Docetaxel, Bladder Cancer, Lung Cancer
Eligibility Criteria
Abreviated Inclusion Criteria
Advanced solid tumor malignancy or relapsed/refractory lymphoma, or
- eligible to receive single-agent pembrolizumab as standard of care, or
- eligible to receive single-agent docetaxel as standard of care, or
- advanced pancreatic adenocarcinoma and eligible to receive gemcitabine plus nab-paclitaxel as standard of care.
- Age 18 years or older, is willing and able to provide informed consent
- Evidence of measurable disease
- Life expectancy > 12 weeks and Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
Abbreviated Exclusion Criteria
- History of allergy or hypersensitivity to study treatment components. Patients with a history of severe hypersensitivity reaction to any monoclonal antibody.
- Use of investigational agent within 28 days prior to the first dose of study treatment and throughout the study
- Receiving high-dose systemic steroid therapy or any other form of immunosuppressive therapy
- History of severe autoimmune disease
- Uncontrolled intercurrent illness or other active malignancy requiring ongoing treatment
Sites / Locations
- UC Irvine Cancer Center
- UC Davis Comprehensive Cancer Center
- University of California, San Francisco
- Sylvester Comprehensive Cancer Center
- Norton Cancer Institute
- Nebraska Cancer Center Oncology Hematology West P.C.
- Rutgers Cancer Institute of New Jersey
- Montefiore Medical Center
- Columbia University Irving Medical Center
- Memorial Sloan Kettering Cancer Center
- University Hospitals Cleveland Medical Center
- UPMC Hillman Cancer Center
- West Cancer Center and Research Institute
- Sarah Cannon Research Institute
- NEXT Oncology
- Huntsman Cancer Intitute
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Arm 1, Single Agent
Arm 2, Anti-PD-1 Combination
Arm 4, Chemotherapy Combination
Arm Description
TTX-030
TTX-030 plus pembrolizumab
TTX-030 plus gemcitabine plus nab-paclitaxel
Outcomes
Primary Outcome Measures
Recommended Phase 2 Dose (RP2D)
Assess the safety profile, dose limiting toxicity (DLT), maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) of TTX-030 when administered intravenously (IV) as a single agent and in combination with agents in specified regimens to subjects with advanced solid tumor malignancies or lymphoma
Secondary Outcome Measures
Anti-tumor activity
Anti-tumor activity in subjects treated with TTX-030 as single agent or in combination with specified regimens
Maximum Plasma Concentration (Cmax)
Pharmacokinetics (PK) of TTX-030
CD39 Expression
Pharmacodynamic (PD) biomarkers relating to mechanism of action and immune responses
Full Information
NCT ID
NCT03884556
First Posted
March 16, 2019
Last Updated
October 2, 2023
Sponsor
Trishula Therapeutics, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT03884556
Brief Title
TTX-030 Single Agent and in Combination With Immunotherapy or Chemotherapy for Patients With Advanced Cancers
Official Title
Phase 1/1b Study of the Safety of TTX-030 as a Single Agent and in Combination With Pembrolizumab or Chemotherapy in Patients With Lymphoma or Solid Tumor Malignancies
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
April 10, 2019 (Actual)
Primary Completion Date
November 30, 2022 (Actual)
Study Completion Date
September 29, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Trishula Therapeutics, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Solid Tumor, Lymphoma
Keywords
Cancer, Metastatic Solid Tumors, Advanced Solid Tumors, Relapsed/Refractory Lymphoma, Prostrate Cancer, Pancreatic Cancer, Monotherapy, Combination Therapy, CD39, Adenosine Pathway, Immunotherapy, Immuno-oncology, PD-1, Checkpoint Inhibitor, Nab-paclitaxel, Gemcitabine, Pembrolizumab, Docetaxel, Bladder Cancer, Lung Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
56 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm 1, Single Agent
Arm Type
Experimental
Arm Description
TTX-030
Arm Title
Arm 2, Anti-PD-1 Combination
Arm Type
Experimental
Arm Description
TTX-030 plus pembrolizumab
Arm Title
Arm 4, Chemotherapy Combination
Arm Type
Experimental
Arm Description
TTX-030 plus gemcitabine plus nab-paclitaxel
Intervention Type
Drug
Intervention Name(s)
TTX-030
Intervention Description
Variable dose and schedule
Intervention Type
Drug
Intervention Name(s)
Pembrolizumab
Intervention Description
Dose and schedule per standard of care
Intervention Type
Drug
Intervention Name(s)
Gemcitabine
Intervention Description
Dose and schedule per standard of care
Intervention Type
Drug
Intervention Name(s)
nab paclitaxel
Intervention Description
Dose and schedule per standard of care
Primary Outcome Measure Information:
Title
Recommended Phase 2 Dose (RP2D)
Description
Assess the safety profile, dose limiting toxicity (DLT), maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) of TTX-030 when administered intravenously (IV) as a single agent and in combination with agents in specified regimens to subjects with advanced solid tumor malignancies or lymphoma
Time Frame
1 cycle (each cycle is 21-28 days)
Secondary Outcome Measure Information:
Title
Anti-tumor activity
Description
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
Title
Maximum Plasma Concentration (Cmax)
Description
Pharmacokinetics (PK) of TTX-030
Time Frame
Cycles 1-3 (each cycle is 21-28 days)
Title
CD39 Expression
Description
Pharmacodynamic (PD) biomarkers relating to mechanism of action and immune responses
Time Frame
Through study completion, an average of 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Abreviated Inclusion Criteria
Advanced solid tumor malignancy or relapsed/refractory lymphoma, or
eligible to receive single-agent pembrolizumab as standard of care, or
eligible to receive single-agent docetaxel as standard of care, or
advanced pancreatic adenocarcinoma and eligible to receive gemcitabine plus nab-paclitaxel as standard of care.
Age 18 years or older, is willing and able to provide informed consent
Evidence of measurable disease
Life expectancy > 12 weeks and Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
Abbreviated Exclusion Criteria
History of allergy or hypersensitivity to study treatment components. Patients with a history of severe hypersensitivity reaction to any monoclonal antibody.
Use of investigational agent within 28 days prior to the first dose of study treatment and throughout the study
Receiving high-dose systemic steroid therapy or any other form of immunosuppressive therapy
History of severe autoimmune disease
Uncontrolled intercurrent illness or other active malignancy requiring ongoing treatment
Facility Information:
Facility Name
UC Irvine Cancer Center
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
UC Davis Comprehensive Cancer Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
Sylvester Comprehensive Cancer Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Norton Cancer Institute
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Nebraska Cancer Center Oncology Hematology West P.C.
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68130
Country
United States
Facility Name
Rutgers Cancer Institute of New Jersey
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08903
Country
United States
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Facility Name
Columbia University Irving Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
University Hospitals Cleveland Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44122
Country
United States
Facility Name
UPMC Hillman Cancer Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Facility Name
West Cancer Center and Research Institute
City
Germantown
State/Province
Tennessee
ZIP/Postal Code
38138
Country
United States
Facility Name
Sarah Cannon Research Institute
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
NEXT Oncology
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Huntsman Cancer Intitute
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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TTX-030 Single Agent and in Combination With Immunotherapy or Chemotherapy for Patients With Advanced Cancers
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