Phase 2 Study of TTX-030 and Chemotherapy With or Without Budigalimab for 1L mPDAC Patients
An Open-Label Multicenter 3-Arm Randomized Phase 2 Study to Assess the Efficacy and Safety of TTX-030 and Chemotherapy With or Without Budigalimab, Compared to Chemotherapy Alone, for the Treatment of Patients Not Previously Treated for Metastatic Pancreatic Adenocarcinoma
1 other identifier
interventional
194
7 countries
64
Brief Summary
This is a Phase 2, multicenter, open-label, 3-arm, randomized, parallel group study to evaluate the efficacy and safety of TTX-030 with or without budigalimab in combination with chemotherapy (gemcitabine + nab-paclitaxel) in subjects with metastatic PDAC who did not have prior treatment for metastatic disease and are eligible to receive gemcitabine and nab-paclitaxel chemotherapy as SOC.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 pancreatic-cancer
Started Mar 2024
Shorter than P25 for phase_2 pancreatic-cancer
64 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 22, 2023
CompletedFirst Posted
Study publicly available on registry
November 7, 2023
CompletedStudy Start
First participant enrolled
March 25, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 17, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
March 6, 2026
CompletedResults Posted
Study results publicly available
May 13, 2026
CompletedMay 13, 2026
April 1, 2026
1.6 years
September 22, 2023
March 11, 2026
April 21, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression-free Survival (PFS) - Biomarker Enriched Population
PFS is defined as the time from randomization until first documentation of progression or death from any cause, whichever occurs first
Through study completion, an average of 1 year
Secondary Outcomes (4)
Progression-free Survival (PFS) - Overall Population
Through study completion, an average of 1 year
Objective Response Rate (ORR) - Biomarker Enriched Population
Through study completion, an average of 1 year
Overall Survival (OS) - Biomarker Enriched Population
Through study completion
Number of Participants With Treatment Emergent Adverse Events
Through study completion, up to a max of 2 years
Study Arms (3)
Arm 1
EXPERIMENTALTTX-030 plus nab-paclitaxel and gemcitabine
Arm 2
EXPERIMENTALTTX-030 plus budigalimab plus nab-paclitaxel and gemcitabine
Arm 3
ACTIVE COMPARATORNab-Paclitaxel and gemcitabine
Interventions
Dose and schedule per protocol
Eligibility Criteria
You may qualify if:
- Age 18 years or older, is willing and able to provide informed consent
- Histologically or cytologically confirmed diagnosis of metastatic PDAC.
- No prior systemic treatment for metastatic disease.
- Evidence of measurable disease per RECIST 1.1.
- Appropriate for treatment with nab-paclitaxel and gemcitabine chemotherapy.
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
You may not qualify if:
- History of clinically significant allergy or hypersensitivity to planned study treatment components or to any monoclonal antibody
- Use of investigational agent within 14 days prior to the first dose of study drug
- History of autoimmune disease
- Subject has received live vaccine within 28 days prior to the first dose of study drug
- Has uncontrolled intercurrent illness
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Trishula Therapeutics, Inc.lead
- AbbViecollaborator
Study Sites (64)
Investigative Site
Tucson, Arizona, 85704, United States
Investigative SIte
Hot Springs, Arkansas, 71913, United States
Investigative Site
Bakersfield, California, 93309, United States
Investigative Site
Fullerton, California, 92835, United States
Investigative Site
Los Angeles, California, 90095, United States
Investigative Site
Denver, Colorado, 80218, United States
Investigative Site
St. Petersburg, Florida, 33705, United States
Investigative Site
West Palm Beach, Florida, 33401, United States
Investigative Site
Atlanta, Georgia, 30318, United States
Investigative Site
Wichita, Kansas, 67214, United States
Investigative Site
Baton Rouge, Louisiana, 70809, United States
Investigative Site
Columbia, Maryland, 21044, United States
Investigative Site
Burnsville, Minnesota, 55337, United States
Investigative Site
Las Vegas, Nevada, 89119, United States
Investigative Site
Florham Park, New Jersey, 07932, United States
Investigative Site
Asheville, North Carolina, 28806, United States
Investigative Site
Columbus, Ohio, 43219, United States
Investigative Site
Eugene, Oregon, 97401, United States
Investigative Site
Portland, Oregon, 97239, United States
Investigative Site
Horsham, Pennsylvania, 19044, United States
Investigative Site
Austin, Texas, 78705, United States
Investigative Site
Dallas, Texas, 75246, United States
Investigative Site
San Antonio, Texas, 78258, United States
Investigative Site
Tyler, Texas, 75702, United States
Investigative Site
Arlington, Virginia, 22205, United States
Investigative Site
Norfolk, Virginia, 23502, United States
Investigative Site
Roanoke, Virginia, 24014, United States
Investigative Site
Milwaukee, Wisconsin, 53226, United States
Investigative Site
Albury, New South Wales, 2640, Australia
Investigative Site
Westmead, New South Wales, 2145, Australia
Investigative Site
Herston, Queensland, 4029, Australia
Investigative Site
Besançon, 25030, France
Investigative Site
Dijon, 21079, France
Investigative Site
Lille, 59000, France
Investigative Site
Paris, 75013, France
Investigative Site
Poitiers, 86021, France
Investigative Site
Genova, 16132, Italy
Investigative Site
Meldola, 47014, Italy
Investigative Site
Milan, 20132, Italy
Investigative Site
Pavia, 27100, Italy
Investigative Site
Puglia, 70124, Italy
Investigative Site
Verona, 37134, Italy
Investigative Site
Goyang-si, 10408, South Korea
Investigative Site
Seongam, 13496, South Korea
Investigative Site
Seongnam-si, 13620, South Korea
Investigative Site
Seoul, 03080, South Korea
Investigative Site
Seoul, 03722, South Korea
Investigative Site
Seoul, 05505, South Korea
Investigative Site
Seoul, 06351, South Korea
Investigative Site
Seoul, 08308, South Korea
Investigative Site
Barcelona, 08009, Spain
Investigative Site
Barcelona, 08035, Spain
Investigative Site
Madrid, 28040, Spain
Investigative Site
Madrid, 28041, Spain
Investigative Site
Madrid, 28050, Spain
Investigative Site
Majadahonda, 28222, Spain
Investigative Site
Pamplona, 31008, Spain
Investigative Site
Valencia, 46009, Spain
Investigative Site
Zaragoza, 50009, Spain
Investigative Site
Kaohsiung City, 833401, Taiwan
Investigative Site
Taichung, 40447, Taiwan
Investigative Site
Tainan, 70403, Taiwan
Investigative Site
Taipei, 112, Taiwan
Investigative Site
Taoyuan, Taiwan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Trishula
- Organization
- TrishulaThera
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 22, 2023
First Posted
November 7, 2023
Study Start
March 25, 2024
Primary Completion
November 17, 2025
Study Completion
March 6, 2026
Last Updated
May 13, 2026
Results First Posted
May 13, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share