Non-Small Cell Lung Cancer NSCLC
Conditions
Keywords
Nanjing Drum Tower Hospital
Brief summary
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.
Interventions
BIOLOGICALABO2109 and toripalimab
Biological : ABO2109 Injection personalized cancer vaccine Biological: Toripalimab Anti-PD-1 monoclonal antibody
Sponsors
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Suzhou Abogen Biosciences Co., Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence and nature of dose-limiting toxicity (DLT) with ABO2109 monotherapy（Dose Exploration) | From the first dose of ABO2109 through 21 days post-dose for each dose-escalation cohort |
| Incidence and severity of TEAE, TESAE, and TEAE leading to study treatment interruption or premature discontinuation following study treatment（Dose Exploration) | From the start of study intervention until 30 days after the last dose of ABO2109/90 days after the last dose of toripalimab, or until the initiation of new antineoplastic therapy, whichever occurs first. |
| Changes in ECOG performance status score（Dose Exploration) | From baseline until 30 days after the last dose of ABO2109/90 days after the last dose of toripalimab, or until the initiation of new antineoplastic therapy, whichever occurs first. |
| DFS based on RECIST Version 1.1 (Dose Expansion) | 3 years |
Contacts
CONTACTYongsheng Wang
Outcome results
None listed