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

Solid Tumor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05198752
• Other study ID #: SWP1001-06
• Status: Recruiting
• Phase: Phase 1
• 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
• 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.

Related Conditions & MeSH terms

• Neoplasms
• Solid Tumor

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