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.
≥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.
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
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Lead sponsor
Suzhou Abogen Biosciences Co., Ltd.
Collaborator