A Study of Neoantigen mRNA Personalised Cancer in Patients With Advanced Solid Tumors
Rekrutierend
NCT-Nummer:
NCT05198752
Studienbeginn:
März 2022
Letztes Update:
17.10.2022
Wirkstoff:
Neoantigen mRNA Personalised Cancer SW1115C3
Indikation (Clinical Trials):
Neoplasms
Geschlecht:
Alle
Altersgruppe:
Erwachsene (18+)
Phase:
Phase 1
Sponsor:
Stemirna Therapeutics
Collaborator:
-
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.
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.
Primary outcome:
1. ，Dose-limiting toxicity incidence (participants who experience DLT) (Time Frame - 21 day)
Secondary outcome:
1. Objective response rate(ORR) assessment per RECIST Version 1.1 (Time Frame - 1 year)
- Neoantigen mRNA Personalised Cancer SW1115C3:
Subcutaneous Injection
Quelle: ClinicalTrials.gov
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