Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05198752




Registration number
NCT05198752
Ethics application status
Date submitted
5/01/2022
Date registered
20/01/2022
Date last updated
17/10/2022

Titles & IDs
Public title
A Study of Neoantigen mRNA Personalised Cancer in Patients With Advanced Solid Tumors
Scientific 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
Secondary ID [1] 0 0
SWP1001-06
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Solid Tumor 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Neoantigen mRNA Personalised Cancer SW1115C3

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


Treatment: Drugs: Neoantigen mRNA Personalised Cancer SW1115C3
Subcutaneous Injection
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
,Dose-limiting toxicity incidence (participants who experience DLT)
Timepoint [1] 0 0
21 day
Secondary outcome [1] 0 0
Objective response rate(ORR) assessment per RECIST Version 1.1
Timepoint [1] 0 0
1 year

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
18/03/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
12/06/2024
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD,VIC
Recruitment hospital [1] 0 0
Pindara Private Hospital - Benowa
Recruitment hospital [2] 0 0
Peninsula & South Eastern Haematology and Oncology Group - Frankston
Recruitment postcode(s) [1] 0 0
- Benowa
Recruitment postcode(s) [2] 0 0
- Frankston
Recruitment outside Australia
Country [1] 0 0
Austria
State/province [1] 0 0
Western Australia

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Stemirna Therapeutics
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05198752
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05198752