TTX-030 in Combination With Immunotherapy and/or Chemotherapy in Subjects With Advanced Cancers
NCT ID: NCT04306900
Last Updated: 2025-07-29
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
185 participants
INTERVENTIONAL
2020-03-30
2024-03-27
Brief Summary
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This trial will study the safety, tolerability, pharmacokinetics, pharmacodynamics and anti-tumor activity of TTX-030 in combination with immunotherapy and/or standard chemotherapies.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Combo 1
TTX-030 plus budigalimab plus mFOLFOX6
TTX-030, budigalimab and mFOLFOX6
Dose and schedule per protocol
Combo 2
TTX-030 plus budigalimab plus docetaxel
TTX-030, budigalimab and docetaxel
Dose and schedule per protocol
Combo 3
TTX-030 plus mFOLFOX6
TTX-030 and mFOLFOX6
Dose and schedule per protocol
Combo 4
TTX-030 plus pembrolizumab
TTX-030 and pembrolizumab
Dose and schedule per protocol
Combo 5
TTX-030 plus budigalimab (selected tumors evaluated in expansion)
TTX-030 and budigalimab
Dose and schedule per protocol
Combo 6
TTX-030 plus budigalimab plus nab-paclitaxel + gemcitabine
TTX-030, budigalimab, nab-paclitaxel and gemcitabine
Dose and schedule per protocol
Combo 7
TTX-030 plus nab-paclitaxel + gemcitabine
TTX-030, nab-paclitaxel and gemcitabine
Dose and schedule per protocol
Combo 8
Budigalimab plus mFOLFOX6
Budigalimab and mFOLFOX6
Dose and schedule per protocol
Interventions
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TTX-030, budigalimab and mFOLFOX6
Dose and schedule per protocol
TTX-030, budigalimab and docetaxel
Dose and schedule per protocol
TTX-030 and mFOLFOX6
Dose and schedule per protocol
TTX-030 and budigalimab
Dose and schedule per protocol
TTX-030, budigalimab, nab-paclitaxel and gemcitabine
Dose and schedule per protocol
TTX-030 and pembrolizumab
Dose and schedule per protocol
TTX-030, nab-paclitaxel and gemcitabine
Dose and schedule per protocol
Budigalimab and mFOLFOX6
Dose and schedule per protocol
Eligibility Criteria
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Inclusion Criteria
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
Exclusion Criteria
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
18 Years
110 Years
ALL
No
Sponsors
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AbbVie
INDUSTRY
Trishula Therapeutics, Inc.
INDUSTRY
Responsible Party
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Locations
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HonorHealth Research Institute
Scottsdale, Arizona, United States
City of Hope Medical Center Clinical Trials Office
Duarte, California, United States
University of Southern California
Los Angeles, California, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
UCLA Hematology/Oncology
Los Angeles, California, United States
Chao Family Comprehensive CC, UCI
Orange, California, United States
UC Davis Comprehensive Cancer Center
Sacramento, California, United States
Sylvester Comprehensive Cancer Center, University of Miami Miller School of Medicine
Miami, Florida, United States
Ocala Oncology Center PL
Ocala, Florida, United States
Orlando Health UF Health Cancer Center
Orlando, Florida, United States
IACT Health - John B. Amos Cancer Center
Columbus, Georgia, United States
University of Chicago Medical Center
Chicago, Illinois, United States
Norton Cancer Institute
Louisville, Kentucky, United States
Ochsner Medical Center
New Orleans, Louisiana, United States
Nebraska Cancer Center Oncology Hematology West P.C.
Omaha, Nebraska, United States
Montefiore Medical Center
The Bronx, New York, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
University of Toledo
Toledo, Ohio, United States
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, United States
Prisma-Health Cancer Institute
Greenville, South Carolina, United States
West Cancer Center and Research Institute
Germantown, Tennessee, United States
Sarah Cannon Research Institute
Nashville, Tennessee, United States
NEXT Oncology
San Antonio, Texas, United States
Hunstman Cancer Intitute
Salt Lake City, Utah, United States
Virginia Cancer Specialists
Fairfax, Virginia, United States
Froedtert Hospital & Medical College of Wisconsin
Milwaukee, Wisconsin, United States
National Cancer Center
Seogu, Busan, South Korea
National Cancer Center
Ilsandong-gu, Goyang-si, Gyeonggi-do, South Korea
Seoul National University
Seongnam-si Bundan-gu, Gyeonggi-do, South Korea
Samsung Medical Center
Gangnam-gu, Seoul, South Korea
Severance Hospital Yonsei University
Seodaemun-gu, Seoul, South Korea
Asan Medical Center
Songpa-gu, Seoul, South Korea
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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TTX-030-002
Identifier Type: -
Identifier Source: org_study_id
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