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

StatusRecruiting
PhaseEarly Phase 1
Started2024-08-29
View on ClinicalTrials.gov ↗
Record status
This record was last updated May 1, 2025 (before its estimated July 2026 completion). Its status may not reflect the trial's current state.

Amendment history

2025-04-29
Study Identification, Study Status, Arms and Interventions, Outcome Measures v3
Secondary endpoints6 entries, revised
OverallObjective Response Rate (ORR): Number of Participants with Tumor Response (Partial or Complete)
Study titlerevised
An Exploratory Study of Individualized Neo-antigen MRNAmRNA Cancer Vaccine InnoPCV in Advanced Solid Tumor Treatment
2024-11-19
Study Identification, Study Status, Oversight, Arms and Interventions, Eligibility v2
Start dateestimated 2024-08→confirmed 2024-08-29
InterventionsBiological: InnoPCV (Drug), Biological: Tislelizumab (Drug)→Biological: InnoPCV (Drug), Biological: PD-1 (Drug)
Eligibility criteria-129 characters
[...] roup (ECOG) Performance Scale. Life expectation >= 12weeks. Participants must have at least one measurable lesion based on RECIST v1.1. Participants must have a formalin-fixed paraffin-embedded (F [...] ing (NGS) required for this study. Adequate organ function. ParticipantParticipants must agree to use adequate contraception from the first dos [...] ment therapy) caused by therapy administered within 4 weeks prior tobefore the first dose of tislelizumabPD-1. Participants with a history of (non-study tumor) malignanc [...] inoma, in situ cervical or breast carcinoma) within 3 years prior tobefore the first dose of [...] [...]
Study titlerevised
An Exploratory Study of Individualized Neo-antigen mRNAMRNA Cancer Vaccine InnoPCV in Advanced Solid Tumor Treatment
2024-07-31
Not Yet Recruiting→Recruiting Study Status, Outcome Measures, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start date2024-07→2024-08
Study sites0→1
Secondary endpointsdetails revised at 2 of 6 entries
2024-07-04
Original filing
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).
Trial Details
NCT Number NCT06497010
Lead Sponsor The Affiliated Hospital Of Guizhou Medical University
Collaborators: Innovac Therapeutics
Conditions Advanced Solid Tumor
Enrollment 40 participants
Start Date 2024-08-29
Primary Completion 2026-07 (estimated)
Study Completion 2026-12 (estimated)
Updated on ClinicalTrials.gov 2025-05-01