Individualized mRNA cancer vaccine for advanced solid tumors
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 study is testing a personalized mRNA cancer vaccine to see if it can help people with advanced solid tumors feel better when combined with another treatment.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | The Affiliated Hospital Of Guizhou Medical University Academic / other |
| Drugs / interventions | CAR-T, chimeric antigen receptor, chemotherapy |
| Locations | 1 site (Guiyang, China/Guizhou) |
| Trial ID | NCT06497010 on ClinicalTrials.gov |
What this trial studies
This exploratory clinical study aims to evaluate the safety and efficacy of an individualized neo-antigen mRNA cancer vaccine, InnoPCV, in patients with advanced solid tumors. The study is divided into two phases: a dose escalation phase (Phase Ia) to determine the recommended phase 2 dose (RP2D) based on safety and immune response, followed by an expansion phase (Phase Ib) targeting specific advanced solid tumors. Participants will receive the vaccine alongside PD-1 therapy, with a focus on assessing immune-related characteristics and preliminary efficacy data.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18-75 with advanced unresectable solid tumors and adequate organ function.
Not a fit: Patients with solid tumors that are resectable or those who do not meet the eligibility criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a personalized treatment option for patients with advanced solid tumors, potentially improving their outcomes.
How similar studies have performed: While the use of neo-antigen vaccines is a growing field, this specific approach is exploratory and may not have been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Guiyang, China/Guizhou
- The Affiliated Hospital of Guizhou Medical University — Guiyang, China/Guizhou, China (Recruiting)
Study contacts
- Principal investigator: Shengfa Su, MD,PhD — The Affiliated Hospital Of Guizhou Medical University
- Study coordinator: Shengfa Su, MD,PhD
- Email: sushengfa2005@163.com
- Phone: +86-13608550432
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.