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

Sponsor
Stemirna Therapeutics (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05198752
Collaborator
(none)
36
Enrollment
1
Arm
27
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Neoantigen mRNA Personalised Cancer SW1115C3
 Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
36 participants
Allocation:
N/A
Intervention Model:
Sequential Assignment
Intervention Model Description:
36 participants in Cohort (C)1: 25 mcg of SW1115C3; C2: 50 mcg of SW1115C3; C3: 100 mcg of SW1115C3; C4: 150mcg of SW1115C3.36 participants in Cohort (C)1: 25 mcg of SW1115C3; C2: 50 mcg of SW1115C3; C3: 100 mcg of SW1115C3; C4: 150mcg of SW1115C3.
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Anticipated Study Start Date :
Mar 12, 2022
Anticipated Primary Completion Date :
Dec 22, 2023
Anticipated Study Completion Date :
Jun 12, 2024

Arms and Interventions

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.

Drug: Neoantigen mRNA Personalised Cancer SW1115C3
Suspension for injection

Outcome Measures

Primary Outcome Measures

  1. ，Dose-limiting toxicity incidence (participants who experience DLT) [21 day]

Secondary Outcome Measures

  1. Objective response rate(ORR) assessment per RECIST Version 1.1 [1 year]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Stemirna Therapeutics

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Stemirna Therapeutics
ClinicalTrials.gov Identifier:
NCT05198752
Other Study ID Numbers:
  • SWP1001-06
First Posted:
Jan 20, 2022
Last Update Posted:
Feb 10, 2022
Last Verified:
Feb 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Neoplasms

Study Results

No Results Posted as of Feb 10, 2022