- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05198752
A Study of Neoantigen mRNA Personalised Cancer in Patients With Advanced Solid Tumors
October 12, 2022 updated by: Stemirna Therapeutics
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
30
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Queensland
-
Benowa, Queensland, Australia
- Recruiting
- Pindara Private Hospital
-
Contact:
- Andrea Tazbirkova
- Phone Number: 0756576400
- Email: dratazbirkova@iconcancercare.com.au
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Principal Investigator:
- Andrea Tazbirkova
-
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Victoria
-
Frankston, Victoria, Australia
- Recruiting
- Peninsula & South Eastern Haematology and Oncology Group
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Contact:
- Vinod Ganju
- Phone Number: 0397815244
- Email: vg@paso.com.au
-
-
-
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Western Australia
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Nedlands, Western Australia, Austria
- Recruiting
- One Clinical Research
-
Contact:
- Mihitha Ariyapperuma
- Phone Number: 0862799466
- Email: mihitha.ariyapperuma@oneclinicalresearch.com.au
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
Subcutaneous Injection
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
,Dose-limiting toxicity incidence (participants who experience DLT)
Time Frame: 21 day
|
21 day
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Objective response rate(ORR) assessment per RECIST Version 1.1
Time Frame: 1 year
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 18, 2022
Primary Completion (Anticipated)
December 22, 2023
Study Completion (Anticipated)
June 12, 2024
Study Registration Dates
First Submitted
January 5, 2022
First Submitted That Met QC Criteria
January 19, 2022
First Posted (Actual)
January 20, 2022
Study Record Updates
Last Update Posted (Actual)
October 17, 2022
Last Update Submitted That Met QC Criteria
October 12, 2022
Last Verified
October 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SWP1001-06
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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-
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-
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-
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-
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-
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-
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Clinical Trials on Neoantigen mRNA Personalised Cancer SW1115C3
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-
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-
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-
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-
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-
National Cancer Institute (NCI)TerminatedMelanoma | Colon Cancer | Gastrointestinal Cancer | Hepatocellular Cancer | Genitourinary CancerUnited States
-
jianming xuNeoCuraRecruitingGastric Cancer | Esophageal Cancer | Liver CancerChina
-
Merck Sharp & Dohme LLCModernaTX, Inc.RecruitingMelanomaSpain, Italy, Poland, Brazil, Australia, Chile, Canada, Portugal, Turkey, Germany, Greece, Israel, Sweden, New Zealand, United States, Belgium, France, Taiwan, United Kingdom, Switzerland, South Africa, Denmark, Argentina
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Jinling Hospital, ChinaJiangsu Synthgene Biotechnology Co.Ltd.RecruitingPancreatic CancerChina
-
Fudan UniversityNot yet recruitingAdvanced Solid TumorsChina