YL-13027 and/or HY-0102 Combined With AG Regimen Chemotherapy for Metastatic Pancreatic Cancer
NCT ID: NCT06662669
Last Updated: 2024-10-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE1/PHASE2
120 participants
INTERVENTIONAL
2024-11-30
2028-08-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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GroupA (YL-13027+AG )
YL-13027: 180mg BID PO Nab-paclitaxel: 125mg/m2, ivgtt, D1、D8、D15 Q4W Gemcitabine: 1000mg/m2, ivgtt, D1、D8、D15 Q4W
YL-13027
YL-13027 is a small molecule inhibitor of the TGF-βRI target.
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
Group B (HY-0102+AG )
HY-0102: 10mg , ivgtt, D1、D15 Q4W Nab-paclitaxel: 125mg/m2, ivgtt, D1、D8、D15 Q4W Gemcitabine: 1000mg/m2, ivgtt, D1、D8、D15 Q4W
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
Group C (YL-13027+HY-0102+AG)
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
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
Group D (AG)
Nab-paclitaxel: 125mg/m2, ivgtt, D1、D8、D15 Q4W Gemcitabine: 1000mg/m2, ivgtt, D1、D8、D15 Q4W
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
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
75 Years
ALL
No
Sponsors
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Shanghai YingLi Pharmaceutical Co. Ltd.
INDUSTRY
Responsible Party
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Central Contacts
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Other Identifiers
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YL-13027-004
Identifier Type: -
Identifier Source: org_study_id
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