Clinical trial NCT04306900: TTX-030 in Combination With Immunotherapy and/or Chemotherapy in Subjects With Advanced Cancers
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Solid Tumor, Adult
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
Lead sponsor: Trishula Therapeutics, Inc.
Sponsor class: INDUSTRY
Collaborators: name: AbbVie
First posted: 2020-03-13
Enrollment: 185
Sex: ALL
Minimum age (years): 18
Maximum age (years): 110
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Adverse Events
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
measure: Objective Response Rate (ORR)
timeFrame: Through study completion, an average of 1 year
measure: Duration of response (DoR)
timeFrame: Through study completion, an average of 1 year
measure: Disease control rate (DCR)
timeFrame: Through study completion, an average of 1 year
measure: Progression-free survival (PFS)
timeFrame: Through study completion, an average of 1 year
measure: Pharmacokinetics (PK)
timeFrame: Cycles 1-4 (each cycle is 21-28 days)
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: HonorHealth Research Institute
state: Arizona
city: Duarte
country: United States
facility: City of Hope Medical Center Clinical Trials Office
state: California
city: Los Angeles
country: United States
facility: University of Southern California
state: California
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: Los Angeles
country: United States
facility: UCLA Hematology/Oncology
state: California
city: Orange
country: United States
facility: Chao Family Comprehensive CC, UCI
state: California
city: Sacramento
country: United States
facility: UC Davis Comprehensive Cancer Center
state: California
city: Miami
country: United States
facility: Sylvester Comprehensive Cancer Center, University of Miami Miller School of Medicine
state: Florida
city: Ocala
country: United States
facility: Ocala Oncology Center PL
state: Florida
city: Orlando
country: United States
facility: Orlando Health UF Health Cancer Center
state: Florida
city: Columbus
country: United States
facility: IACT Health - John B. Amos Cancer Center
state: Georgia
city: Chicago
country: United States
facility: University of Chicago Medical Center
state: Illinois
city: Louisville
country: United States
facility: Norton Cancer Institute
state: Kentucky
city: New Orleans
country: United States
facility: Ochsner Medical Center
state: Louisiana
city: Omaha
country: United States
facility: Nebraska Cancer Center Oncology Hematology West P.C.
state: Nebraska
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center
state: Ohio
city: Toledo
country: United States
facility: University of Toledo
state: Ohio
city: Pittsburgh
country: United States
facility: UPMC Hillman Cancer Center
state: Pennsylvania
city: Greenville
country: United States
facility: Prisma-Health Cancer Institute
state: South Carolina
city: Germantown
country: United States
facility: West Cancer Center and Research Institute
state: Tennessee
city: Nashville
country: United States
facility: Sarah Cannon Research Institute
state: Tennessee
city: San Antonio
country: United States
facility: NEXT Oncology
state: Texas
city: Salt Lake City
country: United States
facility: Hunstman Cancer Intitute
state: Utah
city: Fairfax
country: United States
facility: Virginia Cancer Specialists
state: Virginia
city: Milwaukee
country: United States
facility: Froedtert Hospital & Medical College of Wisconsin
state: Wisconsin
city: Seogu
country: Korea, Republic of
facility: National Cancer Center
state: Busan
city: Ilsandong-gu
country: Korea, Republic of
facility: National Cancer Center
state: Goyang-si, Gyeonggi-do
city: Seongnam-si Bundan-gu
country: Korea, Republic of
facility: Seoul National University
state: Kyunggi-do
city: Gangnam-gu
country: Korea, Republic of
facility: Samsung Medical Center
state: Seoul
city: Seodaemun-gu
country: Korea, Republic of
facility: Severance Hospital Yonsei University
state: Seoul
city: Songpa-gu
country: Korea, Republic of
facility: Asan Medical Center
state: Seoul
Study officials:
References: