計劃書編號TTX-030-003
NCT Number(ClinicalTrials.gov Identfier)NCT06119217
2023-11-01 - 2027-12-31
Phase II
召募中5
一項開放性、多中心、3 組、隨機分配、第 2 期試驗，旨在評估 TTX-030 和化療併用或不併用 budigalimab 相較於單獨給予化療，用於治療先前未接受過轉移性胰腺癌治療之患者的療效和安全性
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試驗委託 / 贊助單位名稱
Trishula Therapeutics, Inc.
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臨床試驗規模
多國多中心
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更新日期
2025/08/20
試驗主持人及試驗醫院
實際收案人數
0 召募中
實際收案人數
0 召募中
實際收案人數
0 召募中
適應症
轉移性胰腺癌
試驗目的
評估 TTX-030 併用或不併用 budigalimab 合併 nab-paclitaxel + gemcitabine 用於人類白血球抗原 (HLA)-DQ高族群的效益
藥品名稱
TTX-030
Budigalimab (ABBV-181)
Budigalimab (ABBV-181)
主成份
TTX-030
Budigalimab (ABBV-181)
Budigalimab (ABBV-181)
劑型
Solution for Infusion
Powder for Solution for Infusion
Powder for Solution for Infusion
劑量
30 mg/ml
100 mg/vial
100 mg/vial
評估指標
無惡化存活期 (PFS)
主要納入條件
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.
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.
主要排除條件
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
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
試驗計畫預計收納受試者人數
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台灣人數
25 人
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全球人數
180 人
