A Phase 1 Clinical Study to Evaluate the Tolerability, Safety,Immunogenicity and Efficacy of the Neoantigen mRNA Personalised Cancer Vaccine SW1115C3 in Patients With Advanced Malignant Solid Tumours

Stemirna Therapeutics3 sites in 2 countries30 target enrollmentMarch 18, 2022

ConditionsSolid Tumor

InterventionsNeoantigen mRNA Personalised Cancer SW1115C3

DrugsNeoantigen mRNA Personalised Cancer SW1115C3

Overview

Phase: Phase 1
Intervention: Neoantigen mRNA Personalised Cancer SW1115C3
Conditions: Solid Tumor
Sponsor: Stemirna Therapeutics
Enrollment: 30
Locations: 3
Primary Endpoint: ，Dose-limiting toxicity incidence (participants who experience DLT)
Status: Recruiting
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

March 18, 2022

End Date

June 12, 2024

Last Updated

3 years ago

Study Type

Interventional

Study Design

Sequential

Sex

All

Investigators

Sponsor

Stemirna Therapeutics

Responsible Party

Sponsor

Eligibility Criteria

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.