A Study of Neoantigen mRNA Personalised Cancer in Patients With Advanced Solid Tumors

Last updated: October 12, 2022
Sponsor: Stemirna Therapeutics
Overall Status: Active - Recruiting

Phase

1

Condition

Neuroblastoma

Neoplasms

Treatment

N/A

Clinical Study ID

NCT05198752
SWP1001-06
  • Ages 18-80
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Are 18 to 80 years old (including boundary values), without limitation of sex at timeof consent.
  • Based on the RECIST 1.1 criteria for disease progression, (a maximum increase intumour diameter of 20%) for participants undergoing prescreening who are receivingstandard treatment, these participants may reach the defined disease progressioncriteria at the time of tumour vaccine administration.

Exclusion

Exclusion Criteria:

  • Have used a live attenuated vaccine within 4 weeks before the first use of SW1115C3with the following exceptions:
  • Adverse reactions induced by previous anti-tumour treatments have not yet recovered toGrade ≤ 1 (except for toxicity evaluated to have no risk of safety by the PI [ordesignee], such as hair loss, Grade 2 peripheral neurotoxicity and hypothyroidismstabilised by hormone-replacement therapy) based on NCI CTCAE version 5.0.

Study Design

Total Participants: 30
Study Start date:
March 18, 2022
Estimated Completion Date:
June 12, 2024

Connect with a study center

  • Pindara Private Hospital

    Benowa, Queensland
    Australia

    Active - Recruiting

  • Peninsula & South Eastern Haematology and Oncology Group

    Frankston, Victoria
    Australia

    Active - Recruiting

  • One Clinical Research

    Nedlands, Western Australia
    Austria

    Active - Recruiting

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