Clinical trial NCT06119217: Phase 2 Study of TTX-030 and Chemotherapy With or Without Budigalimab for 1L mPDAC Patients
Official title: 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Pancreatic Cancer
Keywords: Cancer
Pancreatic Adenocarcinoma
Combination Therapy
CD39
Adenosine Pathway
Immunotherapy
Immuno-oncology
Pancreatic Ductal Adenocarcinoma
PD-1 Checkpoint Inhibitor
Budigalimab
TTX-030
metastatic
Lead sponsor: Trishula Therapeutics, Inc.
Sponsor class: INDUSTRY
Collaborators: name: AbbVie
First posted: 2023-11-07
Enrollment: 194
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, Parallel Group Study
Primary purpose: TREATMENT

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.


Eligibility criteria: Abbreviated Inclusion Criteria:

1. Age 18 years or older, is willing and able to provide informed consent
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.

Abbreviated Exclusion Criteria:

1. History of clinically significant allergy or hypersensitivity to planned study treatment components or to any monoclonal antibody
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

Primary outcomes:
measure: Progression-free survival (PFS) - Biomarker Enriched Population
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
measure: Progression-free survival (PFS) - Overall Population
timeFrame: Through study completion, an average of 1 year
measure: Objective Response Rate (ORR)
timeFrame: Through study completion, an average of 1 year
measure: Duration of Response (DoR)
timeFrame: Through study completion, an average of 1 year
measure: Overall Survival (OS)
timeFrame: Through study completion, an average of 1 year
measure: Adverse Events
timeFrame: Through study completion, an average of 1 year
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Investigative Site
state: Arizona
city: Hot Springs
country: United States
facility: Investigative SIte
state: Arkansas
city: Bakersfield
country: United States
facility: Investigative Site
state: California
city: Fullerton
country: United States
facility: Investigative Site
state: California
city: Los Angeles
country: United States
facility: Investigative Site
state: California
city: Denver
country: United States
facility: Investigative Site
state: Colorado
city: Saint Petersburg
country: United States
facility: Investigative Site
state: Florida
city: West Palm Beach
country: United States
facility: Investigative Site
state: Florida
city: Atlanta
country: United States
facility: Investigative Site
state: Georgia
city: Wichita
country: United States
facility: Investigative Site
state: Kansas
city: Baton Rouge
country: United States
facility: Investigative Site
state: Louisiana
city: Columbia
country: United States
facility: Investigative Site
state: Maryland
city: Burnsville
country: United States
facility: Investigative Site
state: Minnesota
city: Las Vegas
country: United States
facility: Investigative Site
state: Nevada
city: Florham Park
country: United States
facility: Investigative Site
state: New Jersey
city: Asheville
country: United States
facility: Investigative Site
state: North Carolina
city: Columbus
country: United States
facility: Investigative Site
state: Ohio
city: Eugene
country: United States
facility: Investigative Site
state: Oregon
city: Portland
country: United States
facility: Investigative Site
state: Oregon
city: Horsham
country: United States
facility: Investigative Site
state: Pennsylvania
city: Austin
country: United States
facility: Investigative Site
state: Texas
city: Dallas
country: United States
facility: Investigative Site
state: Texas
city: San Antonio
country: United States
facility: Investigative Site
state: Texas
city: Tyler
country: United States
facility: Investigative Site
state: Texas
city: Arlington
country: United States
facility: Investigative Site
state: Virginia
city: Norfolk
country: United States
facility: Investigative Site
state: Virginia
city: Roanoke
country: United States
facility: Investigative Site
state: Virginia
city: Milwaukee
country: United States
facility: Investigative Site
state: Wisconsin
city: Albury
country: Australia
facility: Investigative Site
state: New South Wales
city: Westmead
country: Australia
facility: Investigative Site
state: New South Wales
city: Herston
country: Australia
facility: Investigative Site
state: Queensland
city: Besançon
country: France
facility: Investigative Site
city: Dijon
country: France
facility: Investigative Site
city: Lille
country: France
facility: Investigative Site
city: Paris
country: France
facility: Investigative Site
city: Poitiers
country: France
facility: Investigative Site
city: Genova
country: Italy
facility: Investigative Site
city: Meldola
country: Italy
facility: Investigative Site
city: Milano
country: Italy
facility: Investigative Site
city: Pavia
country: Italy
facility: Investigative Site
city: Puglia
country: Italy
facility: Investigative Site
city: Verona
country: Italy
facility: Investigative Site
city: Goyang-si
country: Korea, Republic of
facility: Investigative Site
city: Seongam
country: Korea, Republic of
facility: Investigative Site
city: Seongnam-si
country: Korea, Republic of
facility: Investigative Site
city: Seoul
country: Korea, Republic of
facility: Investigative Site
city: Seoul
country: Korea, Republic of
facility: Investigative Site
city: Seoul
country: Korea, Republic of
facility: Investigative Site
city: Seoul
country: Korea, Republic of
facility: Investigative Site
city: Seoul
country: Korea, Republic of
facility: Investigative Site
city: Barcelona
country: Spain
facility: Investigative Site
city: Barcelona
country: Spain
facility: Investigative Site
city: Madrid
country: Spain
facility: Investigative Site
city: Madrid
country: Spain
facility: Investigative Site
city: Madrid
country: Spain
facility: Investigative Site
city: Majadahonda
country: Spain
facility: Investigative Site
city: Pamplona
country: Spain
facility: Investigative Site
city: Valencia
country: Spain
facility: Investigative Site
city: Zaragoza
country: Spain
facility: Investigative Site
city: Kaohsiung
country: Taiwan
facility: Investigative Site
city: Taichung
country: Taiwan
facility: Investigative Site
city: Tainan
country: Taiwan
facility: Investigative Site
city: Taipei
country: Taiwan
facility: Investigative Site
city: Taoyuan
country: Taiwan
facility: Investigative Site
Study officials:
References: