A Phase Ib/II, Open-label Clinical Study to Evaluate the Safety, Tolerability and Antitumor Activities of IN10018+Standard Chemotherapy and IN10018+Standard Chemotherapy+KN046 in Subjects With Advanced Pancreatic Cancer
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.
• With a full understanding of the study, each subject voluntarily agreed to participate in this study and sign the informed consent form.
• Female or male subjects ≥ 18 years at the time of signing informed consent.
• Histological or cytology-confirmed pancreatic ductal adenocarcinoma (including adenosquamous carcinoma).
• No previous systemic treatment for unresectable, locally advanced, or metastatic pancreatic cancer.
• At least one measurable lesion per RECIST 1.1.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Life expectancy of at least 3 months as assessed by the investigator.
• 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.
• Adequate bone marrow, liver, renal, and coagulation function .
⁃ A female subject is eligible to participate if she is not pregnant, not breastfeeding, and at least 1 of the following conditions applies:
∙ Not a woman of childbearing potential (WOCBP) . or
‣ A WOCBP who agrees to follow the contraceptive guidance.