NCT06119217CompletedPhase 2
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
Source: ClinicalTrials.gov · Last updated 13 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 194 (actual)
- First submitted
- 22 Sept 2023
- Start date
- 25 Mar 2024
- Primary completion date
- 17 Nov 2025
- Lead sponsor
- Trishula Therapeutics, Inc.
- Diseases
- Pancreatic cancer
- NCT number
- NCT06119217
- EU CT number
- 2023-508356-19-00
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 194
- From 25 Mar 2024 to the primary completion date, 17 Nov 2025
- 62 sites in 8 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Criteria the registry did not label
- Abbreviated Inclusion Criteria:
- 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.
- Abbreviated Exclusion Criteria:
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (62)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Investigative Site Coordinator of this site? Confirm its status | Albury | Australia | Unknown status |
| Investigative Site Coordinator of this site? Confirm its status | Herston | Australia | Unknown status |
| Investigative Site Coordinator of this site? Confirm its status | Westmead | Australia | Unknown status |
| Fakultni nemocnice Brno Coordinator of this site? Confirm its status | Brno | Czechia | Completed |
| Nemocnice AGEL Nový Jičín a.s. Coordinator of this site? Confirm its status | Nový Jičín | Czechia | Completed |
| University Hospital Olomouc Coordinator of this site? Confirm its status | Olomouc | Czechia | Completed |
| Vseobecna Fakultni Nemocnice V Praze Coordinator of this site? Confirm its status | Prague 2 | Czechia | Completed |
| Hospital de la Santa Creu i Sant Pau Coordinator of this site? Confirm its status | Barcelona | Spain | Completed |
| Hospital Universitari Vall d'Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Completed |
| Hospital Universitario 12 de Octubre Coordinator of this site? Confirm its status | Madrid | Spain | Completed |
| Hospital Universitario La Paz Coordinator of this site? Confirm its status | Madrid | Spain | Completed |
| Clinica Universidad de Navarra Coordinator of this site? Confirm its status | Madrid | Spain | Completed |
| Hospital Universitario HM Sanchinarro Coordinator of this site? Confirm its status | Madrid | Spain | Completed |
| Hospital Universitario Puerta de Hierro de Majadahonda Coordinator of this site? Confirm its status | Majadahonda | Spain | Completed |
| Clínica Universidad de navarra Coordinator of this site? Confirm its status | Pamplona | Spain | Completed |
| Hospital Universitario Y Politecnico La Fe Coordinator of this site? Confirm its status | Valencia | Spain | Completed |
| Hospital Unviersitario Miguel Servet Coordinator of this site? Confirm its status | Zaragoza | Spain | Completed |
| Besancon University Hospital Center Coordinator of this site? Confirm its status | Besancon Cedex | France | Completed |
| Centr Georges Francois Leclerc Coordinator of this site? Confirm its status | Dijon | France | Completed |
| Centre Oscar Lambret Coordinator of this site? Confirm its status | Lille | France | Completed |
| Assistance Publique Hopitaux De Paris Coordinator of this site? Confirm its status | Paris Cedex 13 | France | Completed |
| Centre Hospitalier Universitaire de Poitiers Coordinator of this site? Confirm its status | Poitiers | France | Completed |
| IRCCS Ospedale Policlinico San Martino Coordinator of this site? Confirm its status | Genoa | Italy | Completed |
| Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST S.r.l Coordinator of this site? Confirm its status | Meldola | Italy | Completed |
| Azienda Ospedaliera Universitaria Integrata Verona Coordinator of this site? Confirm its status | Verona | Italy | Completed |
| Investigative Site Coordinator of this site? Confirm its status | Goyang-si | South Korea | Unknown status |
| Investigative Site Coordinator of this site? Confirm its status | Seongam | South Korea | Unknown status |
| Investigative Site Coordinator of this site? Confirm its status | Seongnam-si | South Korea | Unknown status |
| Investigative Site Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Investigative Site Coordinator of this site? Confirm its status | Kaohsiung City | Taiwan | Unknown status |
| Investigative Site Coordinator of this site? Confirm its status | Taichung | Taiwan | Unknown status |
| Investigative Site Coordinator of this site? Confirm its status | Tainan | Taiwan | Unknown status |
| Investigative Site Coordinator of this site? Confirm its status | Taipei | Taiwan | Unknown status |
| Investigative Site Coordinator of this site? Confirm its status | Taoyuan | Taiwan | Unknown status |
| Investigative Site Coordinator of this site? Confirm its status | Arlington | United States | Unknown status |
| Investigative Site Coordinator of this site? Confirm its status | Asheville | United States | Unknown status |
| Investigative Site Coordinator of this site? Confirm its status | Atlanta | United States | Unknown status |
| Investigative Site Coordinator of this site? Confirm its status | Austin | United States | Unknown status |
| Investigative Site Coordinator of this site? Confirm its status | Bakersfield | United States | Unknown status |
| Investigative Site Coordinator of this site? Confirm its status | Baton Rouge | United States | Unknown status |
| Investigative Site Coordinator of this site? Confirm its status | Burnsville | United States | Unknown status |
| Investigative Site Coordinator of this site? Confirm its status | Columbia | United States | Unknown status |
| Investigative Site Coordinator of this site? Confirm its status | Columbus | United States | Unknown status |
| Investigative Site Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| Investigative Site Coordinator of this site? Confirm its status | Denver | United States | Unknown status |
| Investigative Site Coordinator of this site? Confirm its status | Eugene | United States | Unknown status |
| Investigative Site Coordinator of this site? Confirm its status | Florham Park | United States | Unknown status |
| Investigative Site Coordinator of this site? Confirm its status | Fullerton | United States | Unknown status |
| Investigative Site Coordinator of this site? Confirm its status | Horsham | United States | Unknown status |
| Investigative SIte Coordinator of this site? Confirm its status | Hot Springs | United States | Unknown status |
| Investigative Site Coordinator of this site? Confirm its status | Las Vegas | United States | Unknown status |
| Investigative Site Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| Investigative Site Coordinator of this site? Confirm its status | Milwaukee | United States | Unknown status |
| Investigative Site Coordinator of this site? Confirm its status | Norfolk | United States | Unknown status |
| Investigative Site Coordinator of this site? Confirm its status | Portland | United States | Unknown status |
| Investigative Site Coordinator of this site? Confirm its status | Roanoke | United States | Unknown status |
| Investigative Site Coordinator of this site? Confirm its status | San Antonio | United States | Unknown status |
| Investigative Site Coordinator of this site? Confirm its status | St. Petersburg | United States | Unknown status |
| Investigative Site Coordinator of this site? Confirm its status | Tucson | United States | Unknown status |
| Investigative Site Coordinator of this site? Confirm its status | Tyler | United States | Unknown status |
| Investigative Site Coordinator of this site? Confirm its status | West Palm Beach | United States | Unknown status |
| Investigative Site Coordinator of this site? Confirm its status | Wichita | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.