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Combination Therapy of Personalized mRNA-0217 Vaccines and Pembrolizumab in Patients With Advanced Solid Tumors

NCT05916248 · Status: RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2025-04-01

No results posted yet for this study

Summary

The main objective of this study was to observe and evaluate the safety and tolerability of mRNA-0217/S001 vaccine encoding personalized tumor neoantigens alone/in combination with Pembrolizumab injection for the treatment of advanced solid tumors. The secondary objective was to observe the preliminary efficacy of mRNA-0217/S001 personalized tumor vaccine in the treatment of advanced solid tumors with neoantigen-specific CD4+ and CD8+ T lymphocyte responses, objective tumor response rate (ORR) and disease control rate (DCR), progression-free survival (PFS) and overall survival (OS) caused by mRNA-0217/S001 personalized tumor vaccine.

Conditions

  • Advanced Solid Tumor

Interventions

BIOLOGICAL

Personalized neoantigen tumor vaccine

Neoantigen tumor vaccine

BIOLOGICAL

PD-1 inhibitor

pembrolizumab

Sponsors & Collaborators

  • Shanghai Xinpu BioTechnology Company Limited

    collaborator UNKNOWN

  • Ruijin Hospital

    lead OTHER

Principal Investigators

  • Baiyong Shen, M.D.&Ph.D · Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-20
Primary Completion
2026-06-30
Completion
2026-12-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05916248 on ClinicalTrials.gov