YL-13027 and/or HY-0102 Combined With AG Regimen Chemotherapy for Metastatic Pancreatic Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: YL-13027, HY-0102, Gemcitabine, Nab-paclitaxel.
- Who it may be relevant to
- Registry conditions: Metastatic Pancreatic Cancer. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Randomized, Open, Parallel-controlled, Multi-center , Phase Ib/Ⅱ Clinical Trial of YL-13027 and/or HY-0102 Combined With AG（Nab-paclitaxel and Gemcitabine) Regimen Chemotherapy for Metastatic Pancreatic Cancer
Overview
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
- Drug YL-13027
YL-13027 is a small molecule inhibitor of the TGF-βRI target. - Drug HY-0102
HY-0102 is a recombinant anti-NKG2A humanized monoclonal antibody. - Drug Gemcitabine
Gemcitabine is a pyrimidine antineoplastic chemotherapeutic agent. - Drug Nab-paclitaxel
Paclitaxel for Injection (albumin bound) is a chemotherapeutic agent that acts as an antitumor agent by inhibiting tumor cell mitosis
Primary outcome measures
- Objective response rate [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 [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.]
Secondary outcome measures (3)
- Disease control rate [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 [Time frame: From time of first dose to 30 days after the last dose.]
- Plasma concentration of YL-13027 and HY-0102 [Time frame: From one hour before the first dose to the last dose up to 24months.]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06662669 · YL-13027-004