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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05198752
Other study ID # SWP1001-06
Secondary ID
Status Recruiting
Phase Phase 1
First received
Last updated
Start date March 18, 2022
Est. completion date June 12, 2024

Study information

Verified date October 2022
Source Stemirna Therapeutics
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date June 12, 2024
Est. primary completion date December 22, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Neoantigen mRNA Personalised Cancer SW1115C3
Subcutaneous Injection

Locations

Country Name City State
Australia Pindara Private Hospital Benowa Queensland
Australia Peninsula & South Eastern Haematology and Oncology Group Frankston Victoria
Austria One Clinical Research Nedlands Western Australia

Sponsors (1)

Lead Sponsor Collaborator
Stemirna Therapeutics

Countries where clinical trial is conducted

Australia,  Austria, 

Outcome

Type Measure Description Time frame Safety issue
Primary ,Dose-limiting toxicity incidence (participants who experience DLT) 21 day
Secondary Objective response rate(ORR) assessment per RECIST Version 1.1 1 year
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