Clinical Trials List
2023-11-01 - 2027-12-31
Phase II
Recruiting5
ICD-10C25.0
Malignant neoplasm of head of pancreas
ICD-10Z51.12
Encounter for antineoplastic immunotherapy
ICD-9157.0
Malignant neoplasm of head of pancreas
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
-
Sponsor
-
Trial scale
Multi-Regional Multi-Center
-
Update
2026/02/01
Investigators and Locations
Co-Principal Investigator
- 陳珈妤 無
- Chang-Fang Chiu 無
- Chi-Ching Chen 無
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Pei-Chang Lee Digestive System Department
- Yi-Ping Hung 無
- Hung-Yuan Yu Digestive System Department
- 姜乃榕 無
- 李癸川 Digestive System Department
- Shao-Jung Hsu Digestive System Department
- Ming-Huang Chen 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Wen-Chi Shen Division of Hematology & Oncology
- Jen-Shi Chen 無
- 余紹銘 Division of Hematology & Oncology
- Hung-Chih Hsu 無
- 陳建銘 Division of Radiology
- 徐執中 Division of Hematology & Oncology
- Po-Jung Su 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Chien-Jui Huang Digestive System Department
- Chia-Jui Yen 無
- 蘇勇曄 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Objectives
Test Drug
凍晶注射劑
Active Ingredient
Budigalimab (ABBV-181)
Dosage Form
243
Dosage
100 mg/vial
Endpoints
Inclution 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.
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
The Estimated Number of Participants
-
Taiwan
25 participants
-
Global
180 participants
