Status:
UNKNOWN
A Study of Neoantigen mRNA Personalised Cancer in Patients With Advanced Solid Tumors
Lead Sponsor:
Stemirna Therapeutics
Conditions:
Solid Tumor
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
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 so...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 18 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 12 2024
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT05198752
Start Date
March 18 2022
End Date
June 12 2024
Last Update
October 17 2022
Active Locations (3)
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1
Pindara Private Hospital
Benowa, Queensland, Australia
2
Peninsula & South Eastern Haematology and Oncology Group
Frankston, Victoria, Australia
3
One Clinical Research
Nedlands, Western Australia, Austria