Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Suzhou Abogen Biosciences Co., Ltd. | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose Exploration Part | Experimental | For participants in dose exploration, the first treatment cycle consists of ABO2109 monotherapy, and combination therapy with tgripalimab is initiated from the second treatment cycle onwards.For participants in dose expansion,will receive ABO2109 in combination therapy with tgripalimab since the first treatment cycle AB02109 will be administered at specified dose defined in the study protocol via an intramuscular(lM)injection on Day 1 of each 21-day cycle for up to 9 cycles, tgripalimak will be administered via intravenous (lV) infusion on Day 1 of each 21-day cycle until progression,unacceptable toxicity,or up to 13 cycles whichever is sooner. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABO2109 Injection | Drug | personalized cancer vaccine |
| |
| Measure | Description | 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. | |
| Disease-Free Survival (DFS) based on RECIST Version 1.1. (Dose Expansion) | 5 years |
Not provided
Not provided
Key Inclusion Criteria:
Key Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xinjing Wang | Contact | 18817821319 | newvista89@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Baiyong Shen | Ruijin Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine | Recruiting | Shanghai | Shanghai Municipality | 200025 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| C000656314 | toripalimab |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Toripalimab |
| Drug |
Anti-PD-1 monoclonal antibody |
|