Brief Summary
This is a phase 1/1b study of TTX-030 in combination therapy, 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, pharmacodynamics and anti-tumor activity of TTX-030 in combination with immunotherapy and/or standard chemotherapies.
This trial will study the safety, tolerability, pharmacokinetics, pharmacodynamics and anti-tumor activity of TTX-030 in combination with immunotherapy and/or standard chemotherapies.
Brief Title
TTX-030 in Combination With Immunotherapy and/or Chemotherapy in Subjects With Advanced Cancers
Categories
Completion Date
Completion Date Type
Actual
Conditions
Solid Tumor, Adult
Eligibility Criteria
Abbreviated Inclusion Criteria:
1. Age 18 years or older, is willing and able to provide informed consent
2. Histologically confirmed diagnosis of unresectable or metastatic solid tumor malignancy in selected tumor types
3. Life expectancy \> 12 weeks
4. ECOG performance status of 0-1
Abbreviated Exclusion Criteria:
1. History of allergy or hypersensitivity to study treatment components. Patients 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
1. Age 18 years or older, is willing and able to provide informed consent
2. Histologically confirmed diagnosis of unresectable or metastatic solid tumor malignancy in selected tumor types
3. Life expectancy \> 12 weeks
4. ECOG performance status of 0-1
Abbreviated Exclusion Criteria:
1. History of allergy or hypersensitivity to study treatment components. Patients 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
Inclusion Criteria
Inclusion Criteria:
1. Age 18 years or older, is willing and able to provide informed consent
2. Histologically confirmed diagnosis of unresectable or metastatic solid tumor malignancy in selected tumor types
3. Life expectancy \> 12 weeks
4. ECOG performance status of 0-1
Abbreviated
1. Age 18 years or older, is willing and able to provide informed consent
2. Histologically confirmed diagnosis of unresectable or metastatic solid tumor malignancy in selected tumor types
3. Life expectancy \> 12 weeks
4. ECOG performance status of 0-1
Abbreviated
Gender
All
Gender Based
false
Keywords
Gastric (gastroesophageal cancer)
Advanced Solid Tumor
Colorectal cancer
Cancer
Metastatic Solid Tumor
Combination Therapy
CD39
Adenosine Pathway
Immunotherapy Immuno-oncology
PD-1 Checkpoint Inhibitor
Docetaxel
Budigalimab
ABBV-181
TTX-030
Non-small cell lung cancer
Urothelial cell cancer
Pancreatic cancer
Pembrolizumab
Keytruda
Bladder cancer
Gemcitabine
Nab-paclitaxel
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Maximum Age
110 Years
Minimum Age
18 Years
NCT Id
NCT04306900
Org Class
Industry
Org Full Name
Trishula Therapeutics, Inc.
Org Study Id
TTX-030-002
Overall Status
Completed
Phases
Phase 1
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
Phase 1/1b Study to Evaluate the Safety and Activity of TTX-030 (Anti-CD39) in Combination With Pembrolizumab or Budigalimab and/or Chemotherapy in Subjects With Advanced Solid Tumors
Primary Outcomes
Outcome Description
Number of study subjects experiencing adverse events (AEs), dose-limiting toxicities, and serious adverse events (SAEs). Safety profile will be assessed through laboratory evaluations, vital signs, and physical examinations.
Outcome Measure
Adverse Events
Outcome Time Frame
Through study completion, an average of 1 year
Secondary Outcomes
Outcome Description
ORR is defined as the proportion of subjects with CR or PR
Outcome Time Frame
Through study completion, an average of 1 year
Outcome Measure
Objective Response Rate (ORR)
Outcome Description
DoR will be defined as the duration from the first documentation of objective response to the first documented disease progression or death due to any cause, whichever occurs first.
Outcome Time Frame
Through study completion, an average of 1 year
Outcome Measure
Duration of response (DoR)
Outcome Description
DCR is defined as the proportion of subjects with CR, PR, or SD
Outcome Time Frame
Through study completion, an average of 1 year
Outcome Measure
Disease control rate (DCR)
Outcome Description
PFS is measured from documentation of progression or death from any cause, whichever occurs first
Outcome Time Frame
Through study completion, an average of 1 year
Outcome Measure
Progression-free survival (PFS)
Outcome Description
Serum concentrations of TTX-030 will be tabulated
Outcome Time Frame
Cycles 1-4 (each cycle is 21-28 days)
Outcome Measure
Pharmacokinetics (PK)
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
110
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Ana Acuna-Villaorduna
Investigator Email
aacunavi@montefiore.org
Investigator Phone