Individualized mRNA cancer vaccine for advanced solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.