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

NCT05198752 | Unknown Phase 1

• 1 other identifier: SWP1001-06
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

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.

Conditions

Solid Tumor

Outcome Measures

Primary Outcomes (1)

• ，Dose-limiting toxicity incidence (participants who experience DLT)

  21 day

Secondary Outcomes (1)

• Objective response rate(ORR) assessment per RECIST Version 1.1

  1 year

Study Arms (1)

Neoantigen mRNA Personalised Cancer

EXPERIMENTAL

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

Interventions

Neoantigen mRNA Personalised Cancer SW1115C3 DRUG

Subcutaneous Injection

Neoantigen mRNA Personalised Cancer

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Stemirna Therapeutics: lead

Study Sites (3)

Pindara Private Hospital

Benowa, Queensland, Australia

RECRUITING

Peninsula & South Eastern Haematology and Oncology Group

Frankston, Victoria, Australia

RECRUITING

One Clinical Research

Nedlands, Western Australia, Austria

RECRUITING

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 30 participants in Cohort (C)1:50 mcg of SW1115C3 ; C2: 100 mcg of SW1115C3; C3: 150 mcg of SW1115C3.

Study Record Dates

• First Submitted: January 5, 2022
• First Posted: January 20, 2022
• Study Start: March 18, 2022
• Primary Completion: December 22, 2023
• Study Completion: June 12, 2024
• Last Updated: October 17, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

AU (2)