Metastatic Pancreatic Cancer
Conditions
Brief 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.
Interventions
DRUGYL-13027
YL-13027 is a small molecule inhibitor of the TGF-βRI target.
DRUGHY-0102
HY-0102 is a recombinant anti-NKG2A humanized monoclonal antibody.
DRUGGemcitabine
Gemcitabine is a pyrimidine antineoplastic chemotherapeutic agent.
DRUGNab-paclitaxel
Paclitaxel for Injection (albumin bound) is a chemotherapeutic agent that acts as an antitumor agent by inhibiting tumor cell mitosis
Sponsors
Shanghai YingLi Pharmaceutical Co. Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Subject aged between 18 and 75 years. * Subject has histologically or cytologically confirmed metastatic pancreatic ductal adenocarcinoma. * Subject has at least one evaluable metastatic lesion according to RECIST 1.1 criteria; * Subject has an ECOG score of 0-1 and is expected to survive more than 3 months; * Subjects have a good level of organ function.
Exclusion criteria
* Subject suitable for potentially curative surgery. * The subject confirmed by tissue or cytology as other pathological types, such as acinar cell carcinoma, neuroendocrine carcinoma, etc. * The subject has previously received gemcitabine and nab-paclitaxel combination therapy within 6 months of progression or intolerance.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective response rate | From the first dose to the date of disease progression or date of death from any cause, whichever comes first，up to 24months. | The proportion of subjects who have a complete response or partial response. |
| Progression-free survival | 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 is defined clinically as the time from randomization to disease progression or death from any cause |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Disease control rate | From the first dose to the date of disease progression or date of death from any cause, whichever comes first，up to 24months. | The proportion of subjects who have a complete response, partial response and stable disease. |
| Adverse events | From time of first dose to 30 days after the last dose. | Incidence of adverse events evaluated by NCI CTCAE v5.0 |
| Plasma concentration of YL-13027 and HY-0102 | From one hour before the first dose to the last dose up to 24months. | This composite endpoint will measure the plasma concentration of YL-13027 and HY-0102. |
Contacts
Primary ContactZhingqiang Wang
Outcome results
None listed