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

April 29, 2025 updated by: Shengfa Su, The Affiliated Hospital Of Guizhou Medical University

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

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • China/Guizhou
      • Guiyang, China/Guizhou, China
        • Recruiting
        • The Affiliated Hospital of Guizhou Medical University
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 18-75 years, male or female.
  • Histologically/cytologically or clinically confirmed advanced unresectable protocol-specified solid malignancies.
  • Participants with Performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale.
  • Life expectation >= 12weeks.
  • Participants must have a formalin-fixed paraffin-embedded (FFPE) tumor sample available (for example, from their prior surgery) that is suitable for the next-generation sequencing (NGS) required for this study.
  • Adequate organ function.
  • Participants must agree to use adequate contraception from the first dose of study medication through 180 days after the last dose of study medication (male and female participants of childbearing potential).

Exclusion Criteria:

  • Not recovered to Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 or better from the adverse events (except for alopecia, vitiligo, neurotoxicity, hypothyroidism hormone replacement therapy) caused by therapy administered within 4 weeks before the first dose of PD-1.
  • Participants with a history of (non-study tumor) malignancy (except for skin squamous cell carcinoma and basal cell carcinoma, in situ cervical or breast carcinoma) within 3 years before the first dose of PD-1.
  • Participation in a study of an investigational agent or using an investigational device within 30 days before the first dose of PD-1.
  • Previously received any adoptive cell therapy (including but not limited to tumor-infiltrating lymphocyte TILs, chimeric antigen receptor T cells (CAR-T) and T cell receptor chimeric T cells (TCR-T)), therapeutic tumor vaccines, etc.
  • Participants received chemotherapy, radiotherapy (palliative radiotherapy is allowed), and immune activator (including but not limited to IL-2) and other antitumor therapy within 21 days before the first dose; Participants received Chinese herbal medicine within 2 weeks before the first dose of PD-1.
  • Major surgery (excluding diagnostic biopsy) or significant trauma had not been fully recovered within 28 days before the first dose of PD-1.
  • Participants received live attenuated vaccine within 28 days before starting study treatment or planned to receive live attenuated vaccine during the study and within 60 days after ending the study drug treatment.
  • Active autoimmune disease or a documented history of autoimmune disease or the syndrome that requires systemic steroids or immunosuppressive agents, except vitiligo or resolved childhood asthma/atopy.
  • Positive for Human Immunodeficiency Virus (HIV), Hepatitis B (HBV-DNA≥ 500IU/ml), or Hepatitis C virus (Hepatitis C Virus Ribonucleic Acid [HCV RNA] (qualitative) is detected).
  • Previously identified hypersensitivity to components of the formulations used in this study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dose Escalation

Part A (PD-1 Run-in):

Participants will receive either tislelizumab (200 mg, IV Q3W) or sintilimab (200 mg, IV Q3W) for a lead-in period of one to three cycles.

Part B( InnoPCV in Combination with PD-1)：

Participants will commence up to nine cycles of combination therapy, consisting of InnoPCV (0.06 - 1 mg, intramuscularly, every three weeks) in conjunction with the anti-PD-1 antibody (200 mg, intravenous infusion, every three weeks).

Part C (PD-1 maintenance treatment)

Participants will continue with maintenance therapy using either tislelizumab (200 mg, IV Q3W) or sintilimab (200 mg, IV Q3W) until disease progression or unacceptable toxicity observed
Drug: Biological: InnoPCV
Intramuscular (IM) injection
Drug: Biological: PD-1
Intravenous (IV) infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Recommended Phase 2 Dose (RP2D)
Time Frame: Baseline through 90 days after last InnoPCV dose
Baseline through 90 days after last InnoPCV dose

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neoantigen-specific T cell Response rate
Time Frame: Baseline through 26 weeks after last InnoPCV dose
Baseline through 26 weeks after last InnoPCV dose
Duration of Response (DoR)
Time Frame: Baseline through disease progression by Response Evaluation Criteria of Solid Tumors Version 1.1 (RECIST 1.1), start of new anti-cancer therapy, withdrawal of consent, death and last safety follow-up visit (up to approximately 2 years)
DoR is defined as time from first tumor response (partial or complete) until either radiological disease progression, clinical/symptomatic disease progression or death (whichever is sooner).
Baseline through disease progression by Response Evaluation Criteria of Solid Tumors Version 1.1 (RECIST 1.1), start of new anti-cancer therapy, withdrawal of consent, death and last safety follow-up visit (up to approximately 2 years)
Progression Free Survival (PFS)
Time Frame: From baseline to disease progression by Response Evaluation Criteria of Solid Tumors Version 1.1 (RECIST 1.1) or death (up to approximately 2 years)
PFS is defined as time between the date of first dose of pembrolizumab and the date of either radiological disease progression, clinical/symptomatic disease progression or death (whichever is sooner).
From baseline to disease progression by Response Evaluation Criteria of Solid Tumors Version 1.1 (RECIST 1.1) or death (up to approximately 2 years)
Overall Survival (OS)
Time Frame: From baseline to approximately 2 years
OS is defined as time between the date of the first dose of study drug and the date of death due to any cause.
From baseline to approximately 2 years
Number of Participants with Adverse Events
Time Frame: Baseline through 90 days after last tislelizumab or sintilimab dose
Baseline through 90 days after last tislelizumab or sintilimab dose
Objective Response Rate (ORR): Number of Participants with Tumor Response (Partial or Complete)
Time Frame: Baseline through disease progression by Response Evaluation Criteria of Solid Tumors Version 1.1 (RECIST 1.1), start of new anti-cancer therapy, withdrawal of consent, death and last safety follow-up visit (up to approximately 2 years)
ORR is defined as the proportion of participants whose best overall response is complete response (CR) or partial response (PR).
Baseline through disease progression by Response Evaluation Criteria of Solid Tumors Version 1.1 (RECIST 1.1), start of new anti-cancer therapy, withdrawal of consent, death and last safety follow-up visit (up to approximately 2 years)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Affiliated Hospital Of Guizhou Medical University

Collaborators

Innovac Therapeutics

Investigators

  • Principal Investigator: Shengfa Su, MD,PhD, The Affiliated Hospital of Guizhou Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 29, 2024

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

July 4, 2024

First Submitted That Met QC Criteria

July 4, 2024

First Posted (Actual)

July 11, 2024

Study Record Updates

Last Update Posted (Actual)

May 1, 2025

Last Update Submitted That Met QC Criteria

April 29, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • InnoPCV-001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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