Solid Tumor
Conditions
Brief summary
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.
Interventions
DRUGNeoantigen mRNA Personalised Cancer SW1115C3
Subcutaneous Injection
Sponsors
Stemirna Therapeutics
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
30 participants in Cohort (C)1:50 mcg of SW1115C3 ; C2: 100 mcg of SW1115C3; C3: 150 mcg of SW1115C3.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Are 18 to 80 years old (including boundary values), without limitation of sex at time of consent. * Based on the RECIST 1.1 criteria for disease progression, (a maximum increase in tumour diameter of 20%) for participants undergoing prescreening who are receiving standard treatment, these participants may reach the defined disease progression criteria at the time of tumour vaccine administration.
Exclusion criteria
* Have used a live attenuated vaccine within 4 weeks before the first use of SW1115C3 with the following exceptions: * Adverse reactions induced by previous anti-tumour treatments have not yet recovered to Grade ≤ 1 (except for toxicity evaluated to have no risk of safety by the PI \[or designee\], such as hair loss, Grade 2 peripheral neurotoxicity and hypothyroidism stabilised by hormone-replacement therapy) based on NCI CTCAE version 5.0.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ，Dose-limiting toxicity incidence (participants who experience DLT) | 21 day |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate(ORR) assessment per RECIST Version 1.1 | 1 year |
Countries
Australia, Austria
Outcome results
None listed