Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
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
Query!
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
Query!
Secondary ID [1]
0
0
SWP1001-06
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Solid Tumor
0
0
Query!
Condition category
Condition code
Intervention/exposure
Study type
Interventional
Query!
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
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
,Dose-limiting toxicity incidence (participants who experience DLT)
Query!
Assessment method [1]
0
0
Query!
Timepoint [1]
0
0
21 day
Query!
Secondary outcome [1]
0
0
Objective response rate(ORR) assessment per RECIST Version 1.1
Query!
Assessment method [1]
0
0
Query!
Timepoint [1]
0
0
1 year
Query!
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.
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
80
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
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.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
N/A
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Other
Query!
Other design features
Query!
Phase
Phase 1
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Recruiting
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
18/03/2022
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
12/06/2024
Query!
Actual
Query!
Sample size
Target
30
Query!
Accrual to date
Query!
Final
Query!
Recruitment in Australia
Recruitment state(s)
QLD,VIC
Query!
Recruitment hospital [1]
0
0
Pindara Private Hospital - Benowa
Query!
Recruitment hospital [2]
0
0
Peninsula & South Eastern Haematology and Oncology Group - Frankston
Query!
Recruitment postcode(s) [1]
0
0
- Benowa
Query!
Recruitment postcode(s) [2]
0
0
- Frankston
Query!
Recruitment outside Australia
Country [1]
0
0
Austria
Query!
State/province [1]
0
0
Western Australia
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Query!
Name
Stemirna Therapeutics
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
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.
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT05198752
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT05198752
Download to PDF