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| Name | Class |
|---|---|
| Suzhou Abogen Biosciences Co., Ltd. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ABO2109 combined with toripalimab | 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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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABO2109 and toripalimab | Biological | Biological : ABO2109 Injection personalized cancer vaccine Biological: 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 | |
|---|---|---|---|---|
| Yongsheng Wang | Contact | 15150580136 | 15150580136@163.com |
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| ID | Term |
|---|---|
| C000656314 | toripalimab |
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