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
A DLT was defined as the occurrence of any of the following toxicities within the DLT Evaluation Period if judged by the Investigator and Sponsor to be possibly, probably, or definitely related to TTX-030 or budigalimab.
Outcome Measure
Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs)
Outcome Time Frame
7 day load + 1 cycle (1 cycle is 28 days)
Outcome Description
Number of study subjects experiencing adverse events (AEs) and serious adverse events (SAEs). Safety profile will be assessed through laboratory evaluations, vital signs, and physical examinations.
Outcome Measure
The Incident of 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
Confirmed Objective Response Rate (ORR)
Outcome Description
The BOR was defined as the best response (in the order of CR, PR, stable disease, and PD) by RECIST 1.1 documented from first dose until the end of study, first disease progression, death, or start of new anticancer therapy, whichever was earliest.
Outcome Time Frame
Through study completion, an average of 1 year
Outcome Measure
Best Response (BOR)
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 per RECIST 1.1
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
OS was defined as the time interval from the first dose of study treatment to death from any cause. Participants who were lost to follow-up or survived until the end of the study were censored at the last date that they were known to be alive. Medians, Q1, and Q3 of OS and the proportion of participants who were alive at 3, 6, 9, and 12 months from Study Day 1 were derived using KM methods.
Outcome Time Frame
Through study completion, an average of 1 year
Outcome Measure
Overall Survival (OS)
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
Categories Mesh Debug
Gastrointestinal (GI) Cancers --- COLORECTAL NEOPLASMS
Cancer --- NEOPLASMS
Lung & Chest Cancers --- CARCINOMA, NON-SMALL-CELL LUNG
Gastrointestinal (GI) Cancers --- INTESTINAL NEOPLASMS
Gastrointestinal (GI) Cancers --- GASTROINTESTINAL NEOPLASMS
Gastrointestinal (GI) Cancers --- DIGESTIVE SYSTEM NEOPLASMS
Cancer --- NEOPLASMS BY SITE
Gastrointestinal (GI) Cancers --- DIGESTIVE SYSTEM DISEASES
Digestive System --- DIGESTIVE SYSTEM DISEASES
Liver --- DIGESTIVE SYSTEM DISEASES
Gastrointestinal (GI) Cancers --- GASTROINTESTINAL DISEASES
Digestive System --- GASTROINTESTINAL DISEASES
Gastrointestinal (GI) Cancers --- COLONIC DISEASES
Digestive System --- COLONIC DISEASES
Gastrointestinal (GI) Cancers --- INTESTINAL DISEASES
Digestive System --- INTESTINAL DISEASES
Lung & Chest Cancers --- CARCINOMA, BRONCHOGENIC
Lung & Chest Cancers --- BRONCHIAL NEOPLASMS
Lung & Chest Cancers --- LUNG NEOPLASMS
Lung & Chest Cancers --- RESPIRATORY TRACT NEOPLASMS
Lung & Chest Cancers --- THORACIC NEOPLASMS
Lung & Chest Cancers --- LUNG DISEASES
COVID-19 --- LUNG DISEASES
Lung --- LUNG DISEASES
Asthma and Other Respiratory Diseases --- RESPIRATORY TRACT DISEASES
Lung & Chest Cancers --- RESPIRATORY TRACT DISEASES
COVID-19 --- RESPIRATORY TRACT DISEASES
Lung --- RESPIRATORY TRACT DISEASES
Endocrine System Cancers --- ENDOCRINE GLAND NEOPLASMS
Endocrine System Cancers --- ENDOCRINE SYSTEM DISEASES
Diabetes --- ENDOCRINE SYSTEM DISEASES
Diabetes & Endocrine System --- ENDOCRINE SYSTEM DISEASES
Prostate Cancer --- UROGENITAL NEOPLASMS
Kidney & Urinary Tract --- URINARY BLADDER DISEASES
Kidney & Urinary Tract --- UROLOGIC DISEASES
MeSH Terms
COLORECTAL NEOPLASMS
NEOPLASMS
NEOPLASM METASTASIS
CARCINOMA, NON-SMALL-CELL LUNG
PANCREATIC NEOPLASMS
URINARY BLADDER NEOPLASMS
INTESTINAL NEOPLASMS
GASTROINTESTINAL NEOPLASMS
DIGESTIVE SYSTEM NEOPLASMS
NEOPLASMS BY SITE
DIGESTIVE SYSTEM DISEASES
GASTROINTESTINAL DISEASES
COLONIC DISEASES
INTESTINAL DISEASES
RECTAL DISEASES
NEOPLASTIC PROCESSES
PATHOLOGIC PROCESSES
PATHOLOGICAL CONDITIONS, SIGNS AND SYMPTOMS
CARCINOMA, BRONCHOGENIC
BRONCHIAL NEOPLASMS
LUNG NEOPLASMS
RESPIRATORY TRACT NEOPLASMS
THORACIC NEOPLASMS
LUNG DISEASES
RESPIRATORY TRACT DISEASES
ENDOCRINE GLAND NEOPLASMS
PANCREATIC DISEASES
ENDOCRINE SYSTEM DISEASES
UROLOGIC NEOPLASMS
UROGENITAL NEOPLASMS
FEMALE UROGENITAL DISEASES
FEMALE UROGENITAL DISEASES AND PREGNANCY COMPLICATIONS
UROGENITAL DISEASES
URINARY BLADDER DISEASES
UROLOGIC DISEASES
MALE UROGENITAL DISEASES
BUDIGALIMAB
DOCETAXEL
130-NM ALBUMIN-BOUND PACLITAXEL
GEMCITABINE
PEMBROLIZUMAB
TAXOIDS
CYCLODECANES
CYCLOPARAFFINS
HYDROCARBONS, ALICYCLIC
HYDROCARBONS, CYCLIC
HYDROCARBONS
ORGANIC CHEMICALS
DITERPENES
TERPENES
HETEROCYCLIC COMPOUNDS
DEOXYCYTIDINE
CYTIDINE
PYRIMIDINE NUCLEOSIDES
PYRIMIDINES
HETEROCYCLIC COMPOUNDS, 1-RING