A Phase 1/2 interventional study of YL-13027 and HY-0102 in Metastatic Pancreatic Cancer, sponsored by Shanghai YingLi Pharmaceutical Co. Ltd.. Not yet recruiting. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-10-29.
Sponsored by Shanghai YingLi Pharmaceutical Co. Ltd. · Phase 1/2, Interventional, and Treatment
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.
3,236 studies on the registry are indexed under Pancreatic Neoplasms; 900 are open to participants now.
This study's planned enrollment of 120 is above the median of 46 across 2,425 interventional studies indexed under Pancreatic Neoplasms.
Browse Pancreatic Neoplasms studies →Shanghai YingLi Pharmaceutical Co. Ltd. is the lead sponsor of 22 studies on the registry; 6 are open to participants now.
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Exclusion Criteria:
YL-13027: 180mg BID PO Nab-paclitaxel: 125mg/m2, ivgtt, D1、D8、D15 Q4W Gemcitabine: 1000mg/m2, ivgtt, D1、D8、D15 Q4W
Drug: YL-13027 · Drug: Gemcitabine · Drug: Nab-paclitaxel
HY-0102: 10mg , ivgtt, D1、D15 Q4W Nab-paclitaxel: 125mg/m2, ivgtt, D1、D8、D15 Q4W Gemcitabine: 1000mg/m2, ivgtt, D1、D8、D15 Q4W
Drug: HY-0102 · Drug: Gemcitabine · Drug: Nab-paclitaxel
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
Drug: YL-13027 · Drug: HY-0102 · Drug: Gemcitabine · Drug: Nab-paclitaxel
Nab-paclitaxel: 125mg/m2, ivgtt, D1、D8、D15 Q4W Gemcitabine: 1000mg/m2, ivgtt, D1、D8、D15 Q4W
Drug: Gemcitabine · Drug: Nab-paclitaxel
YL-13027 is a small molecule inhibitor of the TGF-βRI target.
Also known as: YL-13027 tablet
HY-0102 is a recombinant anti-NKG2A humanized monoclonal antibody.
Also known as: HY-0102 injection
Gemcitabine is a pyrimidine antineoplastic chemotherapeutic agent.
Also known as: Gemcitabine Hydrochloride for Injection
Paclitaxel for Injection (albumin bound) is a chemotherapeutic agent that acts as an antitumor agent by inhibiting tumor cell mitosis
Also known as: Paclitaxel for Injection (albumin bound)
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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This study is not yet recruiting, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.
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Shanghai YingLi Pharmaceutical Co. Ltd.