NCT06662669

YL-13027 and/or HY-0102 Combined With AG Regimen Chemotherapy for Metastatic Pancreatic Cancer

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

• Status: Not Yet Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Shanghai YingLi Pharmaceutical Co. Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Metastatic Pancreatic Cancer

Interventions

Type	Name	Description
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

Timeline

• Start date: 2024-11-30
• Primary completion: 2027-09-30
• Completion: 2028-08-30
• First posted: 2024-10-29
• Last updated: 2024-10-29