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Trial Title:
YL-13027 and/or HY-0102 Combined With AG Regimen Chemotherapy for Metastatic Pancreatic Cancer
NCT ID:
NCT06662669
Condition:
Metastatic Pancreatic Cancer
Conditions: Official terms:
Pancreatic Neoplasms
Paclitaxel
Albumin-Bound Paclitaxel
Gemcitabine
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Single (Participant)
Intervention:
Intervention type:
Drug
Intervention name:
YL-13027
Description:
YL-13027 is a small molecule inhibitor of the TGF-βRI target.
Arm group label:
Group C (YL-13027+HY-0102+AG)
Arm group label:
GroupA (YL-13027+AG )
Other name:
YL-13027 tablet
Intervention type:
Drug
Intervention name:
HY-0102
Description:
HY-0102 is a recombinant anti-NKG2A humanized monoclonal antibody.
Arm group label:
Group B (HY-0102+AG )
Arm group label:
Group C (YL-13027+HY-0102+AG)
Other name:
HY-0102 injection
Intervention type:
Drug
Intervention name:
Gemcitabine
Description:
Gemcitabine is a pyrimidine antineoplastic chemotherapeutic agent.
Arm group label:
Group B (HY-0102+AG )
Arm group label:
Group C (YL-13027+HY-0102+AG)
Arm group label:
Group D (AG)
Arm group label:
GroupA (YL-13027+AG )
Other name:
Gemcitabine Hydrochloride for Injection
Intervention type:
Drug
Intervention name:
Nab-paclitaxel
Description:
Paclitaxel for Injection (albumin bound) is a chemotherapeutic agent that acts as an
antitumor agent by inhibiting tumor cell mitosis
Arm group label:
Group B (HY-0102+AG )
Arm group label:
Group C (YL-13027+HY-0102+AG)
Arm group label:
Group D (AG)
Arm group label:
GroupA (YL-13027+AG )
Other name:
Paclitaxel for Injection (albumin bound)
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Start date:
November 30, 2024
Completion date:
August 30, 2028
Lead sponsor:
Agency:
Shanghai YingLi Pharmaceutical Co. Ltd.
Agency class:
Industry
Source:
Shanghai YingLi Pharmaceutical Co. Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06662669
