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
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
With
Suzhou Abogen Biosciences Co., Ltd.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
≥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.
You may not be if
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
Clareo Health | 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
