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YL-13027 and/or HY-0102 Combined With AG Regimen Chemotherapy for Metastatic Pancreatic Cancer
Sponsor: Shanghai YingLi Pharmaceutical Co. Ltd.
Summary
In Phase 1b study, six subjects will be enrolled in Arm A (YL-13027 + AG regimen) and Arm B (HY-0102 + AG regimen). The first 12 subjects will be evaluated for safety after one cycle. After safety assessment, subjects will start to enroll in Arm C (YL-13027 + HY-0102 + AG regimen). Each group is planned to include 12-20 subjects. According to the safety and efficacy results of 3 arms of subjects in phase Ib, 1-2 groups were selected for expansion, and a randomized controlled study will be conducted with the standard treatment AG （Arm 4）regimen chemotherapy.
Official title: A Randomized, Open, Parallel-controlled, Multi-center , Phase Ib/Ⅱ Clinical Trial of YL-13027 and/or HY-0102 Combined With AG（Nab-paclitaxel and Gemcitabine) Regimen Chemotherapy for Metastatic Pancreatic Cancer
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
120
Start Date
2024-11-30
Completion Date
2028-08-30
Last Updated
2024-10-29
Healthy Volunteers
No
Conditions
Interventions
YL-13027
YL-13027 is a small molecule inhibitor of the TGF-βRI target.
HY-0102
HY-0102 is a recombinant anti-NKG2A humanized monoclonal antibody.
Gemcitabine
Gemcitabine is a pyrimidine antineoplastic chemotherapeutic agent.
Nab-paclitaxel
Paclitaxel for Injection (albumin bound) is a chemotherapeutic agent that acts as an antitumor agent by inhibiting tumor cell mitosis