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

  • STATUS
    Recruiting
  • End date
    Jun 12, 2024
  • participants needed
    30
  • sponsor
    Stemirna Therapeutics
Updated on 21 October 2022

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.

Details
Condition Solid Tumor
Treatment Neoantigen mRNA Personalised Cancer SW1115C3
Clinical Study IdentifierNCT05198752
SponsorStemirna Therapeutics
Last Modified on21 October 2022

Eligibility

Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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