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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GroupA (YL-13027+AG ) | Experimental | YL-13027: 180mg BID PO Nab-paclitaxel: 125mg/m2, ivgtt, D1、D8、D15 Q4W Gemcitabine: 1000mg/m2, ivgtt, D1、D8、D15 Q4W |
|
| Group B (HY-0102+AG ) | Experimental | HY-0102: 10mg , ivgtt, D1、D15 Q4W Nab-paclitaxel: 125mg/m2, ivgtt, D1、D8、D15 Q4W Gemcitabine: 1000mg/m2, ivgtt, D1、D8、D15 Q4W |
|
| Group C (YL-13027+HY-0102+AG) | Experimental | YL-13027: 180mg BID PO HY-0102: 10mg , ivgtt, D1、D15 Q4W Nab-paclitaxel: 125mg/m2, ivgtt, D1、D8、D15 Q4W Gemcitabine: 1000mg/m2, ivgtt, D1、D8、D15 Q4W |
|
| Group D (AG) | Active Comparator | Nab-paclitaxel: 125mg/m2, ivgtt, D1、D8、D15 Q4W Gemcitabine: 1000mg/m2, ivgtt, D1、D8、D15 Q4W |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| YL-13027 | Drug | YL-13027 is a small molecule inhibitor of the TGF-βRI target. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate | The proportion of subjects who have a complete response or partial response. | 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 | From the first dose to the date of disease progression or date of death from any cause, whichever comes first，up to 24months. |
| Measure | Description | Time Frame |
|---|---|---|
| Disease control rate | The proportion of subjects who have a complete response, partial response and stable disease. | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhingqiang Wang | Contact | 020-87343571 | wangzhq@sysucc.org.cn |
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| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
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| ID | Term |
|---|---|
| D000093542 | Gemcitabine |
| D007267 | Injections |
| C520255 | 130-nm albumin-bound paclitaxel |
| D017239 | Paclitaxel |
| ID | Term |
|---|---|
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
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| HY-0102 | Drug | HY-0102 is a recombinant anti-NKG2A humanized monoclonal antibody. |
|
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| Gemcitabine | Drug | Gemcitabine is a pyrimidine antineoplastic chemotherapeutic agent. |
|
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| Nab-paclitaxel | Drug | Paclitaxel for Injection (albumin bound) is a chemotherapeutic agent that acts as an antitumor agent by inhibiting tumor cell mitosis |
|
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Incidence of adverse events evaluated by NCI CTCAE v5.0 |
| 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. | From one hour before the first dose to the last dose up to 24months. |
| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D011743 |
| Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |