Vaccine to treat solid tumors using neoantigens
Anti-cancer Neoantigen Polypeptide Vaccine to Treat Advanced Solid Tumors: Phase I Clinical Trial
This study is testing a personalized vaccine made from cancer markers to see if it can help people with advanced solid tumors feel better and improve their treatment outcomes.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Second Affiliated Hospital of Guangzhou Medical University Academic / other |
| Drugs / interventions | prednisone, immunotherapy |
| Locations | 1 site (Guangzhou) |
| Trial ID | NCT06195293 on ClinicalTrials.gov |
What this trial studies
This phase 1 clinical trial aims to evaluate the safety, tolerance, and preliminary efficacy of a neoantigen polypeptide vaccine designed for patients with advanced solid tumors. The study involves identifying neoantigens through whole exome sequencing and RNA sequencing, followed by the production of a tailored polypeptide vaccine. Patients will receive the vaccine via local injections, and some may also receive additional immunotherapy with PD1/PDL1/CTLA4 antibodies to enhance the treatment's effectiveness. Close follow-up will be conducted to assess clinical outcomes and safety.
Who should consider this trial
Good fit: Ideal candidates are adults with advanced solid tumors who have a life expectancy of more than 12 weeks and meet specific health criteria.
Not a fit: Patients with severe viral infections, known HIV positivity, or those who have previously undergone gene therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this vaccine could provide a novel immunotherapy option for patients with advanced solid tumors.
How similar studies have performed: While this approach is innovative, similar studies using neoantigen vaccines have shown promise in early-phase trials.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1\. Patients with advanced cancer; 2. Life expectancy \>12 weeks; 3. Adequate heart, lung, liver, kidney, and blood function; 4. Available high quality vaccine for human use; 5. Informed consent explained to, understood by and signed by patient/guardian. Patient/guardian given copy of informed consent. \- Exclusion Criteria: 1. Had accepted gene therapy before; 2. Severe virus infection such as HBV, HCV, HIV, et al; 3. Known HIV positivity; 4. Active infectious disease related to bacteria, virus,fungi,et al; 5. Other severe diseases that the investigators consider not appropriate; 6. Pregnant or lactating women; 7. Systemic steroid treatment (greater than or equal to 0.5 mg prednisone equivalent/kg/day); 8. Other conditions that the investigators consider not appropriate.
Where this trial is running
Guangzhou
- Second Affiliated Hospital of Guangzhou Medical University — Guangzhou, China (Recruiting)
Study contacts
- Principal investigator: Zhenfeng Zhang, MD, PhD — Second Affiliated Hospital of Guangzhou Medical University
- Study coordinator: Zhenfeng Zhang, MD, PhD
- Email: zhangzhf@gzhmu.edu.cn
- Phone: 0086-020-39195965
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.