Solid TumorPhase 1NCT05198752
A Study of Neoantigen mRNA Personalised Cancer in Patients With Advanced Solid Tumors
A Phase 1 study testing Neoantigen mRNA Personalised Cancer SW1115C3 in people with Solid Tumor, run by Stemirna Therapeutics at 3 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Solid Tumor
- What is being tested?
- Neoantigen mRNA Personalised Cancer SW1115C3
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 18 Mar 2022to 12 Jun 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Australia2 sites, 2 recruiting
- Recruiting
Pindara Private Hospital
Benowa, Queensland
Andrea Tazbirkova, 0756576400, dratazbirkova@iconcancercare.com.au
Andrea Tazbirkova
- Recruiting
Peninsula & South Eastern Haematology and Oncology Group
Frankston, Victoria
Vinod Ganju, 0397815244, vg@paso.com.au
Vinod Ganju
Austria1 site, 1 recruiting
- Recruiting
One Clinical Research
Nedlands, Western Australia
Mihitha Ariyapperuma, 0862799466, mihitha.ariyapperuma@oneclinicalresearch.com.au
Mihitha Ariyapperuma
About this study
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
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.
- Conditions
- Solid Tumor
- Being tested
- Neoantigen mRNA Personalised Cancer SW1115C3
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neoantigen mRNA Personalised Cancer SW1115C3Drug
Subcutaneous Injection
| Study group | Role | What they receive |
|---|---|---|
| Neoantigen mRNA Personalised Cancer | Experimental | This study is a 3+3 dose escalation design. Participants will receive a total of 6 cycles of SW1115C3 every 21 days. Receives: Drug: Neoantigen mRNA Personalised Cancer SW1115C3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
，Dose-limiting toxicity incidence (participants who experience DLT)
Measured: 21 day
Secondary outcomes (1)
Objective response rate(ORR) assessment per RECIST Version 1.1
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2022
- Study start18 Mar 2022
- Primary completion22 Dec 2023 (estimated)
- Study completion12 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- 30 participants in Cohort (C)1:50 mcg of SW1115C3 ; C2: 100 mcg of SW1115C3; C3: 150 mcg of SW1115C3.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stemirna Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05198752
- Sponsor's protocol ID
- SWP1001-06
- Status last verified
- Oct 2022
- First submitted
- 5 Jan 2022
- Last updated
- 17 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05198752
- Acronym / sponsor ID
- SWP1001-06
- Conditions
- Solid Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Stemirna TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 18 Mar 2022 (actual)
- Primary completion
- 22 Dec 2023 (estimated)
- Study completion
- 12 Jun 2024 (estimated)
- First posted
- 20 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 30 participants in Cohort (C)1:50 mcg of SW1115C3 ; C2: 100 mcg of SW1115C3; C3: 150 mcg of SW1115C3.
| Arm | Type | Receives |
|---|---|---|
| Neoantigen mRNA Personalised Cancer | Experimental | Drug: Neoantigen mRNA Personalised Cancer SW1115C3This study is a 3+3 dose escalation design. Participants will receive a total of 6 cycles of SW1115C3 every 21 days. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neoantigen mRNA Personalised Cancer SW1115C3Subcutaneous Injection | Drug | Neoantigen mRNA Personalised Cancer |
Primary outcome
，Dose-limiting toxicity incidence (participants who experience DLT)
Time frame: 21 day
1 secondary outcome
Objective response rate(ORR) assessment per RECIST Version 1.1
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2022.
- Individual participant dataSharing planned: No
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A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peninsula & South Eastern Haematology and Oncology Group
Frankston, Australia
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Neoantigen mRNA Personalised Cancer SW1115C3 in people with Solid Tumor, run by Stemirna Therapeutics at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Australia, Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
，Dose-limiting toxicity incidence (participants who experience DLT) (time frame: 21 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2022; AzTrials last refreshed its copy on 8 Nov 2026.