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RECRUITING
NCT06497010
EARLY_PHASE1

An Exploratory Study of Individualized Neo-antigen mRNA Cancer Vaccine InnoPCV in Advanced Solid Tumor Treatment

Sponsor: The Affiliated Hospital Of Guizhou Medical University

View on ClinicalTrials.gov

Summary

This is an open-label, prospective, exploratory clinical study, which is divided into two phases: dose escalation phase (Phase Ia) and expansion phase (Phase Ib). After completing the dose-escalation phase (Stage Ia) (5-11 patients), the investigator will select the dose group (RP2D) based on safety, tolerability, and preliminary immune-related characteristics and efficacy data, and choose 2-3 advanced solid tumors to enter the expansion phase (Stage Ib).

Official title: An Open Label, Prospective, Exploratory Study to Assess the Safety and Efficacy of Individualized Neo-antigen mRNA Cancer Vaccine InnoPCV in Combination With PD-1 in Participants With Advanced Solid Tumor

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2024-08-29

Completion Date

2026-12

Last Updated

2025-05-01

Healthy Volunteers

No

Interventions

DRUG

Biological: PD-1

Intravenous (IV) infusion

DRUG

Biological: InnoPCV

Intramuscular (IM) injection

Locations (1)

The Affiliated Hospital of Guizhou Medical University

Guiyang, China/Guizhou, China