An Exploratory Study of Personalized Cancer Vaccine in Adjuvant Therapy of Solid Tumors

An Exploratory Study of Personalized Cancer Vaccine (ABO2109) in Adjuvant Therapy of Solid Tumors

The purpose of this study is to evaluate the safety and tolerability of ABO2109 in combination with toripalimab, and to evaluate the immunogenicity, pharmacokinetics, pharmacodynamics, as well as biomarker characteristics of the investigational cancer vaccine. In addition, the antitumor activity of ABO2109 will be assessed during both dose exploration and expansion stages, the accumulative data will support the clinical development of ABO2109.

Key Inclusion Criteria:

1. ≥18 years of age at time of informed consent
2. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1
3. Life expectancy of ≥6 months
4. Patient diagnosed with solid tumors and is receiving perioperative and/or adjuvant anti-cancer therapy, or patients with advanced solid tumors
5. No evidence of disease progression per investigator within 28 days before the first dose of study intervention
6. Sufficient organ function
7. 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.

Key Exclusion Criteria:

1. For perioperative or adjuvant therapy setting, participants have received systemic anti-tumor treatment previously
2. 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
3. Presence of active or prior history of interstitial lung disease, tuberculosis, or any other condition known to compromise pulmonary function.
4. Presence of active infections
5. History of severe cardiovascular or cerebrovascular diseases occurring within 6-month prior to study treatment
6. Known hypersensitivity to the active ingredients or excipients of ABO2109 or toripalimab.