Safety, Tolerability, Immunogenicity, Pharmacodynamic Characteristics, and Preliminary Anti-tumor Activity of Personalized Cancer Vaccines Alone and in Combination With Toripalimab in Participants With Resected NSCLC

A Clinical Study to Evaluate the Safety, Tolerability, Immunogenicity, Pharmacodynamic Characteristics, and Preliminary Anti-tumor Activity of Personalized Cancer Vaccine Alone and in Combination With Toripalimab in Patients With Resected NSCLC

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, as well as preliminary efficacy of a personalized cancer vaccine alone and in combination with toripalimab in patients with resected NSCLC. The study included dose escalation and dose expansion two parts.

Inclusion Criteria:

Key inclusion criteria:

• ≥18 years of age at time of informed consent
• Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1
• Life expectancy of ≥6 months
• Patient diagnosed with NSCLC and is receiving perioperative and/or adjuvant anti-cancer therapy.
• Sufficient organ function
• Female patients must meet both of the criteria: a) Surgically sterile, or postmenopausal for ≥2 years, or women of childbearing potential with a negative pregnancy test and willing to use effective contraception during the study and for at least 90 days after the last study dose. Use of progesterone-containing contraceptives is not permitted. b) Agree not to breastfeed during the study and for at least 90 days after the last study dose.Male patients must meet the following criteria:If not surgically sterile and potentially engaging in sexual activity that could lead to pregnancy, agree to use effective contraception during the study and for at least 90 days after the last study dose.

Exclusion Criteria:

Key Exclusion Criteria:

• For perioperative or adjuvant therapy setting, participants have received systemic anti-tumor treatment previously
• Any other prior malignancy active within the previous 5 years, except for skin basal cell cancer that has been cured, or superficial bladder cancer, carcinoma in situ of the breast, carcinoma in situ of the cervix, thyroid cancer
• Active or prior history of interstitial lung disease, tuberculosis, or any other condition known to compromise pulmonary function.
• Active infections
• History of severe cardiovascular or cerebrovascular diseases occurring within 6-month prior to study treatment
• Known hypersensitivity to the active ingredients or excipients of ABO2109 or toripalimab
• Positive pregnancy test or lactating women