drugset / Trial / NCT05827796
IN10018+ Standard Chemotherapy (+KN046) in Subjects With Advanced Pancreatic Cancer
Non-randomizedParallel-groupOpen-labelTreatment
Summary
This study is a multicenter, open-label, single-arm, phase Ib/II clinical study comprising two phases: dose confirmation phase and dose expansion phase. The objective of the dose confirmation phase is to determine the recommended Phase II dose (RP2D) of IN10018+ standard chemotherapy (albumin-bound paclitaxel + gemcitabine) and IN10018 + KN046 + standard chemotherapy in subjects with advanced pancreatic cancer. The dose expansion phase will further explore the antitumor activities and safety of combination therapy in subjects with advanced pancreatic cancer.
Timeline
- Start
- 2022-12-08
- Primary completion
- 2025-12-31
- Completion
- 2026-03-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | ERFONRILIMAB | Monoclonal antibody | 5 mg/kg | Intravenous |
| Subject | Ifebemtinib | Small molecule | 25 mg | Oral |
| Subject | Ifebemtinib | Small molecule | 50 mg | Oral |
| Subject | Ifebemtinib | Small molecule | 100 mg | Oral |
| Background | Gemcitabine | Small molecule | 1000 mg/m2 | Intravenous |
| Background | Paclitaxel | Small molecule | 125 mg/m2 | Intravenous |