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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
120
YL-13027 is a small molecule inhibitor of the TGF-βRI target.
HY-0102 is a recombinant anti-NKG2A humanized monoclonal antibody.
Gemcitabine is a pyrimidine antineoplastic chemotherapeutic agent.
Paclitaxel for Injection (albumin bound) is a chemotherapeutic agent that acts as an antitumor agent by inhibiting tumor cell mitosis
Objective response rate
The proportion of subjects who have a complete response or partial response.
Time frame: From the first dose to the date of disease progression or date of death from any cause, whichever comes first，up to 24months.
Progression-free survival
Progression-free survival is defined clinically as the time from randomization to disease progression or death from any cause
Time frame: From the first dose to the date of disease progression or date of death from any cause, whichever comes first，up to 24months.
Disease control rate
The proportion of subjects who have a complete response, partial response and stable disease.
Time frame: From the first dose to the date of disease progression or date of death from any cause, whichever comes first，up to 24months.
Adverse events
Incidence of adverse events evaluated by NCI CTCAE v5.0
Time frame: From time of first dose to 30 days after the last dose.
Plasma concentration of YL-13027 and HY-0102
This composite endpoint will measure the plasma concentration of YL-13027 and HY-0102.
Time frame: From one hour before the first dose to the last dose up to 24months.
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