TTX-030 in Combination With Immunotherapy and/or Chemotherapy in Subjects With Advanced Cancers
- Conditions
- Solid Tumor, Adult
- Interventions
- Combination Product: TTX-030 and mFOLFOX6Combination Product: TTX-030, budigalimab and mFOLFOX6Combination Product: TTX-030 and pembrolizumabCombination Product: TTX-030, nab-paclitaxel and gemcitabineCombination Product: TTX-030, budigalimab and docetaxelCombination Product: TTX-030 and budigalimabCombination Product: TTX-030, budigalimab, nab-paclitaxel and gemcitabineCombination Product: Budigalimab and mFOLFOX6
- Registration Number
- NCT04306900
- Lead Sponsor
- Trishula Therapeutics, Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 185
- Age 18 years or older, is willing and able to provide informed consent
- Histologically confirmed diagnosis of unresectable or metastatic solid tumor malignancy in selected tumor types
- Life expectancy > 12 weeks
- ECOG performance status of 0-1
Abbreviated
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Combo 3 TTX-030 and mFOLFOX6 TTX-030 plus mFOLFOX6 Combo 1 TTX-030, budigalimab and mFOLFOX6 TTX-030 plus budigalimab plus mFOLFOX6 Combo 4 TTX-030 and pembrolizumab TTX-030 plus pembrolizumab Combo 7 TTX-030, nab-paclitaxel and gemcitabine TTX-030 plus nab-paclitaxel + gemcitabine Combo 2 TTX-030, budigalimab and docetaxel TTX-030 plus budigalimab plus docetaxel Combo 5 TTX-030 and budigalimab TTX-030 plus budigalimab (selected tumors evaluated in expansion) Combo 6 TTX-030, budigalimab, nab-paclitaxel and gemcitabine TTX-030 plus budigalimab plus nab-paclitaxel + gemcitabine Combo 8 Budigalimab and mFOLFOX6 Budigalimab plus mFOLFOX6
- Primary Outcome Measures
Name Time Method Adverse Events Through study completion, an average of 1 year 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.
- Secondary Outcome Measures
Name Time Method Disease control rate (DCR) Through study completion, an average of 1 year DCR is defined as the proportion of subjects with CR, PR, or SD
Progression-free survival (PFS) Through study completion, an average of 1 year PFS is measured from documentation of progression or death from any cause, whichever occurs first
Duration of response (DoR) Through study completion, an average of 1 year 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.
Pharmacokinetics (PK) Cycles 1-4 (each cycle is 21-28 days) Serum concentrations of TTX-030 will be tabulated
Objective Response Rate (ORR) Through study completion, an average of 1 year ORR is defined as the proportion of subjects with CR or PR
Trial Locations
- Locations (31)
Cedars-Sinai Medical Center
🇺🇸Los Angeles, California, United States
University Hospitals Cleveland Medical Center
🇺🇸Cleveland, Ohio, United States
UPMC Hillman Cancer Center
🇺🇸Pittsburgh, Pennsylvania, United States
University of Toledo
🇺🇸Toledo, Ohio, United States
NEXT Oncology
🇺🇸San Antonio, Texas, United States
Virginia Cancer Specialists
🇺🇸Fairfax, Virginia, United States
National Cancer Center
🇰🇷Ilsandong-gu, Goyang-si, Gyeonggi-do, Korea, Republic of
City of Hope Medical Center Clinical Trials Office
🇺🇸Duarte, California, United States
Ocala Oncology Center PL
🇺🇸Ocala, Florida, United States
Sylvester Comprehensive Cancer Center, University of Miami Miller School of Medicine
🇺🇸Miami, Florida, United States
HonorHealth Research Institute
🇺🇸Scottsdale, Arizona, United States
Chao Family Comprehensive CC, UCI
🇺🇸Orange, California, United States
West Cancer Center and Research Institute
🇺🇸Germantown, Tennessee, United States
UCLA Hematology/Oncology
🇺🇸Los Angeles, California, United States
Hunstman Cancer Intitute
🇺🇸Salt Lake City, Utah, United States
Froedtert Hospital & Medical College of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States
University of Southern California
🇺🇸Los Angeles, California, United States
University of Chicago Medical Center
🇺🇸Chicago, Illinois, United States
IACT Health - John B. Amos Cancer Center
🇺🇸Columbus, Georgia, United States
UC Davis Comprehensive Cancer Center
🇺🇸Sacramento, California, United States
Orlando Health UF Health Cancer Center
🇺🇸Orlando, Florida, United States
Norton Cancer Institute
🇺🇸Louisville, Kentucky, United States
Severance Hospital Yonsei University
🇰🇷Seodaemun-gu, Seoul, Korea, Republic of
Sarah Cannon Research Institute
🇺🇸Nashville, Tennessee, United States
Seoul National University
🇰🇷Seongnam-si Bundan-gu, Kyunggi-do, Korea, Republic of
Ochsner Medical Center
🇺🇸New Orleans, Louisiana, United States
Samsung Medical Center
🇰🇷Gangnam-gu, Seoul, Korea, Republic of
Asan Medical Center
🇰🇷Songpa-gu, Seoul, Korea, Republic of
Nebraska Cancer Center Oncology Hematology West P.C.
🇺🇸Omaha, Nebraska, United States
Prisma-Health Cancer Institute
🇺🇸Greenville, South Carolina, United States
Montefiore Medical Center
🇺🇸Bronx, New York, United States