Solid Tumors
Conditions
Keywords
The First Affiliated Hospital of Soochow University
Brief summary
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.
Interventions
BIOLOGICALABO2109 Injection;Toripalimab
Drug: ABO2109 Injection personalized cancer vaccine Drug: Toripalimab Anti-PD-1 monoclonal antibody
Sponsors
Suzhou Abogen Biosciences Co., Ltd.
The First Affiliated Hospital of Soochow University
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 solid tumors 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
CONTACTWei Li
CONTACTshi hui Fu
Outcome results
None listed