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

NCT06497010 · Status: RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-05-01

No results posted yet for this study

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).

Conditions

  • Advanced Solid Tumor

Interventions

DRUG

Biological: PD-1

Intravenous (IV) infusion

DRUG

Biological: InnoPCV

Intramuscular (IM) injection

Sponsors & Collaborators

  • Innovac Therapeutics

    collaborator INDUSTRY

  • The Affiliated Hospital Of Guizhou Medical University

    lead OTHER

Principal Investigators

  • Shengfa Su, MD,PhD · The Affiliated Hospital Of Guizhou Medical University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-08-29
Primary Completion
2026-07-31
Completion
2026-12-31

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 NCT06497010 on ClinicalTrials.gov