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

NCT06497010 | Recruiting Early Phase 1

• 1 other identifier: InnoPCV-001
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Recommended Phase 2 Dose (RP2D)

  Baseline through 90 days after last InnoPCV dose

Secondary Outcomes (6)

• Number of Participants with Adverse Events

  Baseline through 90 days after last tislelizumab or sintilimab dose

• Neoantigen-specific T cell Response rate

  Baseline through 26 weeks after last InnoPCV dose

• Objective Response Rate (ORR): Number of Participants with Tumor Response (Partial or Complete)

  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)

• Duration of Response (DoR)

  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)

  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)

Study Arms (1)

Dose Escalation

EXPERIMENTAL

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: PD-1; Drug: Biological: InnoPCV

Interventions

Biological: PD-1 DRUG

Intravenous (IV) infusion

Dose Escalation

Biological: InnoPCV DRUG

Intramuscular (IM) injection

Dose Escalation

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Affiliated Hospital Of Guizhou Medical University: lead
• Innovac Therapeutics: collaborator

Study Sites (1)

The Affiliated Hospital of Guizhou Medical University

Guiyang, China/Guizhou, China

RECRUITING

Study Officials

• Shengfa Su, MD,PhD

  The Affiliated Hospital Of Guizhou Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shengfa Su, MD,PhD

CONTACT

+86-13608550432; sushengfa2005@163.com

Bing Lu, MD

CONTACT

+86-13809432527; lbgymaaaa@163.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: July 4, 2024
• First Posted: July 11, 2024
• Study Start: August 29, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 1, 2025

Record last verified: 2025-04

Locations

CN (1)