A Study of Neoantigen mRNA Personalised Cancer in Patients With Advanced Solid Tumors

Stemirna Therapeutics

Status and phase

Enrolling

Phase 1

Conditions

Solid Tumor

Treatments

Drug: Neoantigen mRNA Personalised Cancer SW1115C3

Study type

Interventional

Funder types

Industry

Identifiers

NCT05198752

SWP1001-06

Details and patient eligibility

About

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.

Enrollment

30 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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.