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This is a Phase 1 open label study to evaluate the tolerability, safety, immunogenicity, and efficacy of SW1115C3, a neoantigen mRNA personalised cancer vaccine, in patients with advanced malignant solid tumours.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Neoantigen mRNA Personalised Cancer | Experimental | This study is a 3+3 dose escalation design. Participants will receive a total of 6 cycles of SW1115C3 every 21 days. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neoantigen mRNA Personalised Cancer SW1115C3 | Drug | Subcutaneous Injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| ,Dose-limiting toxicity incidence (participants who experience DLT) | 21 day |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate(ORR) assessment per RECIST Version 1.1 | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pindara Private Hospital | Recruiting | Benowa | Queensland | Australia |
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30 participants in Cohort (C)1:50 mcg of SW1115C3 ; C2: 100 mcg of SW1115C3; C3: 150 mcg of SW1115C3.
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| Peninsula & South Eastern Haematology and Oncology Group | Recruiting | Frankston | Victoria | Australia |
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| One Clinical Research | Recruiting | Nedlands | Western Australia | Austria |
|