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Clinical Trials List

Protocol NumberTTX-030-003

NCT Number(ClinicalTrials.gov Identfier)NCT06119217

2023-11-01 - 2027-12-31

Phase II

Recruiting5

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

2025/08/20

Investigators and Locations

Principal Investigator Li-Yuan Bai 無

China Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chung-Pin Li 無

Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Wen-Chi Chou 無

Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Tai-Jan Chiu 無

Kaoshiung Chang Gung Memorial Hospital of the C.G.M.F.

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Yan-Shen Shan Division of General Surgery

National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Pancreatic Cancer

Objectives

Evaluate the efficacy of TTX-030 with or without budigalimab and nab-paclitaxel + gemcitabine in human leukocyte antigen (HLA)-DQ high population

Test Drug

TTX-030Budigalimab (ABBV-181)

Active Ingredient

TTX-030
Budigalimab (ABBV-181)

Dosage Form

Solution for Infusion
Powder for Solution for Infusion

Dosage

30 mg/ml
100 mg/vial

Endpoints

Progression-free survival (PFS)

Inclution Criteria

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.

Exclusion Criteria

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

The Estimated Number of Participants

Taiwan

25 participants
Global

180 participants