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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.
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

Full criteria on ClinicalTrials.gov

Sites (62)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Investigative Site
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AlburyAustraliaUnknown status
Investigative Site
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HerstonAustraliaUnknown status
Investigative Site
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WestmeadAustraliaUnknown status
Fakultni nemocnice Brno
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BrnoCzechiaCompleted
Nemocnice AGEL Nový Jičín a.s.
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Nový JičínCzechiaCompleted
University Hospital Olomouc
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OlomoucCzechiaCompleted
Vseobecna Fakultni Nemocnice V Praze
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Prague 2CzechiaCompleted
Hospital de la Santa Creu i Sant Pau
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BarcelonaSpainCompleted
Hospital Universitari Vall d'Hebron
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BarcelonaSpainCompleted
Hospital Universitario 12 de Octubre
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MadridSpainCompleted
Hospital Universitario La Paz
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MadridSpainCompleted
Clinica Universidad de Navarra
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MadridSpainCompleted
Hospital Universitario HM Sanchinarro
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MadridSpainCompleted
Hospital Universitario Puerta de Hierro de Majadahonda
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MajadahondaSpainCompleted
Clínica Universidad de navarra
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PamplonaSpainCompleted
Hospital Universitario Y Politecnico La Fe
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ValenciaSpainCompleted
Hospital Unviersitario Miguel Servet
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ZaragozaSpainCompleted
Besancon University Hospital Center
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Besancon CedexFranceCompleted
Centr Georges Francois Leclerc
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DijonFranceCompleted
Centre Oscar Lambret
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LilleFranceCompleted
Assistance Publique Hopitaux De Paris
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Paris Cedex 13FranceCompleted
Centre Hospitalier Universitaire de Poitiers
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PoitiersFranceCompleted
IRCCS Ospedale Policlinico San Martino
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GenoaItalyCompleted
Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST S.r.l
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MeldolaItalyCompleted
Azienda Ospedaliera Universitaria Integrata Verona
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VeronaItalyCompleted
Investigative Site
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Goyang-siSouth KoreaUnknown status
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SeongamSouth KoreaUnknown status
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Seongnam-siSouth KoreaUnknown status
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SeoulSouth KoreaUnknown status
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Kaohsiung CityTaiwanUnknown status
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TaichungTaiwanUnknown status
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TainanTaiwanUnknown status
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TaipeiTaiwanUnknown status
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TaoyuanTaiwanUnknown status
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ArlingtonUnited StatesUnknown status
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AshevilleUnited StatesUnknown status
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AtlantaUnited StatesUnknown status
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AustinUnited StatesUnknown status
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BakersfieldUnited StatesUnknown status
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Baton RougeUnited StatesUnknown status
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BurnsvilleUnited StatesUnknown status
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ColumbiaUnited StatesUnknown status
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ColumbusUnited StatesUnknown status
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DallasUnited StatesUnknown status
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DenverUnited StatesUnknown status
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EugeneUnited StatesUnknown status
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Florham ParkUnited StatesUnknown status
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FullertonUnited StatesUnknown status
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HorshamUnited StatesUnknown status
Investigative SIte
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Hot SpringsUnited StatesUnknown status
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Las VegasUnited StatesUnknown status
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Los AngelesUnited StatesUnknown status
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MilwaukeeUnited StatesUnknown status
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NorfolkUnited StatesUnknown status
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PortlandUnited StatesUnknown status
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RoanokeUnited StatesUnknown status
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San AntonioUnited StatesUnknown status
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St. PetersburgUnited StatesUnknown status
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TucsonUnited StatesUnknown status
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TylerUnited StatesUnknown status
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West Palm BeachUnited StatesUnknown status
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WichitaUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.