Phase 2 Study of TTX-030 and Chemotherapy With or Without Budigalimab for 1L mPDAC Patients
NCT ID: NCT06119217
Last Updated: 2024-12-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ACTIVE_NOT_RECRUITING
PHASE2
194 participants
INTERVENTIONAL
2024-03-25
2027-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Arm 1
TTX-030 plus nab-paclitaxel and gemcitabine
TTX-030, nab-paclitaxel and gemcitabine
Dose and schedule per protocol
Arm 2
TTX-030 plus budigalimab plus nab-paclitaxel and gemcitabine
TTX-030, budigalimab, nab-paclitaxel and gemcitabine
Dose and schedule per protocol
Arm 3
Nab-Paclitaxel and gemcitabine
Nab-Paclitaxel and gemcitabine
Dose and schedule per protocol
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
TTX-030, nab-paclitaxel and gemcitabine
Dose and schedule per protocol
TTX-030, budigalimab, nab-paclitaxel and gemcitabine
Dose and schedule per protocol
Nab-Paclitaxel and gemcitabine
Dose and schedule per protocol
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Histologically or cytologically confirmed diagnosis of metastatic PDAC.
3. No prior systemic treatment for metastatic disease.
4. Evidence of measurable disease per RECIST 1.1.
5. Appropriate for treatment with nab-paclitaxel and gemcitabine chemotherapy.
6. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
Exclusion Criteria
2. Use of investigational agent within 14 days prior to the first dose of study drug
3. History of autoimmune disease
4. Subject has received live vaccine within 28 days prior to the first dose of study drug
5. Has uncontrolled intercurrent illness
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
AbbVie
INDUSTRY
Trishula Therapeutics, Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Investigative Site
Tucson, Arizona, United States
Investigative SIte
Hot Springs, Arkansas, United States
Investigative Site
Bakersfield, California, United States
Investigative Site
Fullerton, California, United States
Investigative Site
Los Angeles, California, United States
Investigative Site
Denver, Colorado, United States
Investigative Site
St. Petersburg, Florida, United States
Investigative Site
West Palm Beach, Florida, United States
Investigative Site
Atlanta, Georgia, United States
Investigative Site
Wichita, Kansas, United States
Investigative Site
Baton Rouge, Louisiana, United States
Investigative Site
Columbia, Maryland, United States
Investigative Site
Burnsville, Minnesota, United States
Investigative Site
Las Vegas, Nevada, United States
Investigative Site
Florham Park, New Jersey, United States
Investigative Site
Asheville, North Carolina, United States
Investigative Site
Columbus, Ohio, United States
Investigative Site
Eugene, Oregon, United States
Investigative Site
Portland, Oregon, United States
Investigative Site
Horsham, Pennsylvania, United States
Investigative Site
Austin, Texas, United States
Investigative Site
Dallas, Texas, United States
Investigative Site
San Antonio, Texas, United States
Investigative Site
Tyler, Texas, United States
Investigative Site
Arlington, Virginia, United States
Investigative Site
Norfolk, Virginia, United States
Investigative Site
Roanoke, Virginia, United States
Investigative Site
Milwaukee, Wisconsin, United States
Investigative Site
Albury, New South Wales, Australia
Investigative Site
Westmead, New South Wales, Australia
Investigative Site
Herston, Queensland, Australia
Investigative Site
Besançon, , France
Investigative Site
Dijon, , France
Investigative Site
Lille, , France
Investigative Site
Paris, , France
Investigative Site
Poitiers, , France
Investigative Site
Genova, , Italy
Investigative Site
Meldola, , Italy
Investigative Site
Milan, , Italy
Investigative Site
Pavia, , Italy
Investigative Site
Puglia, , Italy
Investigative Site
Verona, , Italy
Investigative Site
Goyang-si, , South Korea
Investigative Site
Seongam, , South Korea
Investigative Site
Seongnam-si, , South Korea
Investigative Site
Seoul, , South Korea
Investigative Site
Seoul, , South Korea
Investigative Site
Seoul, , South Korea
Investigative Site
Seoul, , South Korea
Investigative Site
Seoul, , South Korea
Investigative Site
Barcelona, , Spain
Investigative Site
Barcelona, , Spain
Investigative Site
Madrid, , Spain
Investigative Site
Madrid, , Spain
Investigative Site
Madrid, , Spain
Investigative Site
Majadahonda, , Spain
Investigative Site
Pamplona, , Spain
Investigative Site
Valencia, , Spain
Investigative Site
Zaragoza, , Spain
Investigative Site
Kaohsiung City, , Taiwan
Investigative Site
Taichung, , Taiwan
Investigative Site
Tainan City, , Taiwan
Investigative Site
Taipei, , Taiwan
Investigative Site
Taoyuan District, , Taiwan
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
TTX-030-003
Identifier Type: -
Identifier Source: org_study_id