Trial Title:
Phase 2 Study of TTX-030 and Chemotherapy With or Without Budigalimab for 1L mPDAC Patients
NCT ID:
NCT06119217
Condition:
Pancreatic Cancer
Conditions: Official terms:
Paclitaxel
Albumin-Bound Paclitaxel
Gemcitabine
Conditions: Keywords:
Cancer
Pancreatic Adenocarcinoma
Combination Therapy
CD39
Adenosine Pathway
Immunotherapy
Immuno-oncology
Pancreatic Ductal Adenocarcinoma
PD-1 Checkpoint Inhibitor
Budigalimab
TTX-030
metastatic
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
Randomized, Parallel Group Study
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Combination Product
Intervention name:
TTX-030, nab-paclitaxel and gemcitabine
Description:
Dose and schedule per protocol
Arm group label:
Arm 1
Intervention type:
Combination Product
Intervention name:
TTX-030, budigalimab, nab-paclitaxel and gemcitabine
Description:
Dose and schedule per protocol
Arm group label:
Arm 2
Intervention type:
Combination Product
Intervention name:
Nab-Paclitaxel and gemcitabine
Description:
Dose and schedule per protocol
Arm group label:
Arm 3
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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Investigative Site
Address:
City:
Tucson
Zip:
85704
Country:
United States
Status:
Recruiting
Facility:
Name:
Investigative SIte
Address:
City:
Hot Springs
Zip:
71913
Country:
United States
Status:
Recruiting
Facility:
Name:
Investigative Site
Address:
City:
Bakersfield
Zip:
93309
Country:
United States
Status:
Recruiting
Facility:
Name:
Investigative Site
Address:
City:
Fullerton
Zip:
92835
Country:
United States
Status:
Recruiting
Facility:
Name:
Investigative Site
Address:
City:
Los Angeles
Zip:
90095
Country:
United States
Status:
Recruiting
Facility:
Name:
Investigative Site
Address:
City:
Denver
Zip:
80218
Country:
United States
Status:
Recruiting
Facility:
Name:
Investigative Site
Address:
City:
Saint Petersburg
Zip:
33705
Country:
United States
Status:
Recruiting
Facility:
Name:
Investigative Site
Address:
City:
Tallahassee
Zip:
32308
Country:
United States
Status:
Withdrawn
Facility:
Name:
Investigative Site
Address:
City:
West Palm Beach
Zip:
33401
Country:
United States
Status:
Recruiting
Facility:
Name:
Investigative Site
Address:
City:
Atlanta
Zip:
30318
Country:
United States
Status:
Recruiting
Facility:
Name:
Investigative Site
Address:
City:
Wichita
Zip:
67214
Country:
United States
Status:
Recruiting
Facility:
Name:
Investigative Site
Address:
City:
Baton Rouge
Zip:
70809
Country:
United States
Status:
Recruiting
Facility:
Name:
Investigative Site
Address:
City:
Columbia
Zip:
21044
Country:
United States
Status:
Recruiting
Facility:
Name:
Investigative Site
Address:
City:
Burnsville
Zip:
55337
Country:
United States
Status:
Recruiting
Facility:
Name:
Investigative Site
Address:
City:
Las Vegas
Zip:
89119
Country:
United States
Status:
Recruiting
Facility:
Name:
Investigative Site
Address:
City:
Florham Park
Zip:
07932
Country:
United States
Status:
Recruiting
Facility:
Name:
Investigative Site
Address:
City:
Asheville
Zip:
28806
Country:
United States
Status:
Recruiting
Facility:
Name:
Investigative Site
Address:
City:
Columbus
Zip:
43219
Country:
United States
Status:
Recruiting
Facility:
Name:
Investigative Site
Address:
City:
Eugene
Zip:
97401
Country:
United States
Status:
Recruiting
Facility:
Name:
Investigative Site
Address:
City:
Portland
Zip:
97239
Country:
United States
Status:
Recruiting
Facility:
Name:
Investigative Site
Address:
City:
Horsham
Zip:
19044
Country:
United States
Status:
Recruiting
Facility:
Name:
Investigative Site
Address:
City:
Austin
Zip:
78705
Country:
United States
Status:
Recruiting
Facility:
Name:
Investigative Site
Address:
City:
Dallas
Zip:
75246
Country:
United States
Status:
Recruiting
Facility:
Name:
Investigative Site
Address:
City:
San Antonio
Zip:
78258
Country:
United States
Status:
Recruiting
Facility:
Name:
Investigative Site
Address:
City:
Tyler
Zip:
75702
Country:
United States
Status:
Recruiting
Facility:
Name:
Investigative Site
Address:
City:
Arlington
Zip:
22205
Country:
United States
Status:
Recruiting
Facility:
Name:
Investigative Site
Address:
City:
Norfolk
Zip:
23502
Country:
United States
Status:
Recruiting
Facility:
Name:
Investigative Site
Address:
City:
Roanoke
Zip:
24014
Country:
United States
Status:
Recruiting
Facility:
Name:
Investigative Site
Address:
City:
Milwaukee
Zip:
53226
Country:
United States
Status:
Recruiting
Facility:
Name:
Investigative Site
Address:
City:
Albury
Zip:
2640
Country:
Australia
Status:
Recruiting
Facility:
Name:
Investigative Site
Address:
City:
Westmead
Zip:
2145
Country:
Australia
Status:
Recruiting
Facility:
Name:
Investigative Site
Address:
City:
Herston
Zip:
4029
Country:
Australia
Status:
Recruiting
Facility:
Name:
Investigative Site
Address:
City:
Besançon
Zip:
25030
Country:
France
Status:
Recruiting
Facility:
Name:
Investigative Site
Address:
City:
Dijon
Zip:
21079
Country:
France
Status:
Recruiting
Facility:
Name:
Investigative Site
Address:
City:
Lille
Zip:
59000
Country:
France
Status:
Recruiting
Facility:
Name:
Investigative Site
Address:
City:
Paris
Zip:
75013
Country:
France
Status:
Recruiting
Facility:
Name:
Investigative Site
Address:
City:
Poitiers
Zip:
86021
Country:
France
Status:
Recruiting
Facility:
Name:
Investigative Site
Address:
City:
Genova
Zip:
16132
Country:
Italy
Status:
Recruiting
Facility:
Name:
Investigative Site
Address:
City:
Meldola
Zip:
47014
Country:
Italy
Status:
Recruiting
Facility:
Name:
Investigative Site
Address:
City:
Milano
Zip:
20132
Country:
Italy
Status:
Recruiting
Facility:
Name:
Investigative Site
Address:
City:
Pavia
Zip:
27100
Country:
Italy
Status:
Recruiting
Facility:
Name:
Investigative Site
Address:
City:
Puglia
Zip:
70124
Country:
Italy
Status:
Recruiting
Facility:
Name:
Investigative Site
Address:
City:
Verona
Zip:
37134
Country:
Italy
Status:
Recruiting
Facility:
Name:
Investigative Site
Address:
City:
Goyang-si
Zip:
10408
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Investigative Site
Address:
City:
Seongam
Zip:
13496
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Investigative Site
Address:
City:
Seongnam-si
Zip:
13620
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Investigative Site
Address:
City:
Seoul
Zip:
03080
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Investigative Site
Address:
City:
Seoul
Zip:
03722
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Investigative Site
Address:
City:
Seoul
Zip:
05505
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Investigative Site
Address:
City:
Seoul
Zip:
06351
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Investigative Site
Address:
City:
Seoul
Zip:
08308
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Investigative Site
Address:
City:
Barcelona
Zip:
08009
Country:
Spain
Status:
Recruiting
Facility:
Name:
Investigative Site
Address:
City:
Barcelona
Zip:
08035
Country:
Spain
Status:
Recruiting
Facility:
Name:
Investigative Site
Address:
City:
Madrid
Zip:
28040
Country:
Spain
Status:
Recruiting
Facility:
Name:
Investigative Site
Address:
City:
Madrid
Zip:
28041
Country:
Spain
Status:
Recruiting
Facility:
Name:
Investigative Site
Address:
City:
Madrid
Zip:
28050
Country:
Spain
Status:
Recruiting
Facility:
Name:
Investigative Site
Address:
City:
Majadahonda
Zip:
28222
Country:
Spain
Status:
Recruiting
Facility:
Name:
Investigative Site
Address:
City:
Pamplona
Zip:
31008
Country:
Spain
Status:
Recruiting
Facility:
Name:
Investigative Site
Address:
City:
Valencia
Zip:
46009
Country:
Spain
Status:
Recruiting
Facility:
Name:
Investigative Site
Address:
City:
Zaragoza
Zip:
50009
Country:
Spain
Status:
Recruiting
Facility:
Name:
Investigative Site
Address:
City:
Kaohsiung
Zip:
833401
Country:
Taiwan
Status:
Recruiting
Facility:
Name:
Investigative Site
Address:
City:
Taichung
Zip:
40447
Country:
Taiwan
Status:
Recruiting
Facility:
Name:
Investigative Site
Address:
City:
Tainan
Zip:
70403
Country:
Taiwan
Status:
Recruiting
Facility:
Name:
Investigative Site
Address:
City:
Taipei
Zip:
112
Country:
Taiwan
Status:
Recruiting
Facility:
Name:
Investigative Site
Address:
City:
Taoyuan
Country:
Taiwan
Status:
Recruiting
Start date:
March 25, 2024
Completion date:
June 2027
Lead sponsor:
Agency:
Trishula Therapeutics, Inc.
Agency class:
Industry
Collaborator:
Agency:
AbbVie
Agency class:
Industry
Source:
Trishula Therapeutics, Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06119217
