IN10018+ Standard Chemotherapy (+KN046) in Subjects With Advanced Pancreatic Cancer
Trial Parameters
Brief 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.
Eligibility Criteria
Inclusion Criteria: 1. With a full understanding of the study, each subject voluntarily agreed to participate in this study and sign the informed consent form. 2. Female or male subjects ≥ 18 years at the time of signing informed consent. 3. Histological or cytology-confirmed pancreatic ductal adenocarcinoma (including adenosquamous carcinoma). 4. No previous systemic treatment for unresectable, locally advanced, or metastatic pancreatic cancer. 5. At least one measurable lesion per RECIST 1.1. 6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 7. Life expectancy of at least 3 months as assessed by the investigator. 8. Must have recovered from all AEs due to previous anticancer therapies to ≤ Grade 1 (CTCAE 5.0) or stable status as assessed by the investigator. Subjects with any grade of alopecia and grade 2 peripheral neuropathy could be enrolled. 9. Adequate bone marrow, liver, renal, and coagulation function . 10. A female subject is eligible to participate i