Clinical trial · Interventional
A Study of Neoantigen mRNA Personalised Cancer in Patients With Advanced Solid Tumors
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
NCT05198752CI-TRIAL-00061485unknownPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Neoantigen mRNA Personalised Cancer SW1115C3 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Neoantigen mRNA Personalised Cancer
- description
- This study is a 3+3 dose escalation design. Participants will receive a total of 6 cycles of SW1115C3 every 21 days.
- interventionNames
- Drug: Neoantigen mRNA Personalised Cancer SW1115C3
Primary outcomes (1)
- measure
- ，Dose-limiting toxicity incidence (participants who experience DLT)
- timeFrame
- 21 day
Secondary outcomes (1)
- measure
- Objective response rate(ORR) assessment per RECIST Version 1.1
- timeFrame
- 1 year
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.