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| Name | Class |
|---|---|
| The First Affiliated Hospital of Soochow University | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose Exploration Part | Experimental | Participants will receive ABO2109 at specified dose defined in the study protocol via an intramuscular (IM) injection every three weeks. The first treatment cycle consists of ABO2109 monotherapy, and combination therapy with toripalimab is initiated from the second treatment cycle onwards. |
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| Dose Expansion Part | Experimental | Participants will receive ABO2109 via an IM injection on Day 1 of each 21-day cycle for up to 9 cycles and Toripalimab via IV infusion on Day 1 of each 21-day cycle until progression, unacceptable toxicity, or up to 13 cycles, whichever is sooner. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABO2109 Injection;Toripalimab | Biological | Drug: ABO2109 Injection personalized cancer vaccine Drug: Toripalimab Anti-PD-1 monoclonal antibody |
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| 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 | |
| DFS based on RECIST Version 1.1. (Dose Expansion) | 3 years |
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Inclusion Criteria:
Key inclusion criteria:
Exclusion Criteria:
Key Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wei Li | Contact | +86 15895401045 | liwei10@suda.edu.cn | |
| shi hui Fu | Contact |
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| ABO2109 Injection;Toripalimab | Biological | Drug: ABO2109 Injection personalized cancer vaccine Drug: Toripalimab Anti-PD-1 monoclonal antibody |
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