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

Phase 1

Recruiting

• Conditions: Solid Tumor
• Interventions: Drug: Neoantigen mRNA Personalised Cancer SW1115C3

• Registration Number: NCT05198752
• Lead Sponsor: Stemirna Therapeutics

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-01-05
• Study First Submitted QC: 2022-01-19
• Study First Posted: 2022-01-20
• Study Start: 2022-03-18
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-12
• Last Update Posted: 2022-10-17
• Primary Completion: 2023-12-22
• Study Completion: 2024-06-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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.

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Neoantigen mRNA Personalised Cancer	Neoantigen mRNA Personalised Cancer SW1115C3	This study is a 3+3 dose escalation design. Participants will receive a total of 6 cycles of SW1115C3 every 21 days.

Primary Outcome Measures

Name	Time	Method
，Dose-limiting toxicity incidence (participants who experience DLT)	21 day

Secondary Outcome Measures

Name	Time	Method
Objective response rate(ORR) assessment per RECIST Version 1.1	1 year

Trial Locations

Locations (3)

Pindara Private Hospital; 🇦🇺 Benowa, Queensland, Australia

Peninsula & South Eastern Haematology and Oncology Group; 🇦🇺 Frankston, Victoria, Australia

One Clinical Research; 🇦🇹 Nedlands, Western Australia, Austria