Clinical trial Recruiting at 1 site Phase 1 Interventional Ages 18 to 75

Vaccine to treat solid tumors using neoantigens

Official title: Anti-cancer Neoantigen Polypeptide Vaccine to Treat Advanced Solid Tumors: Phase I Clinical Trial

Run by Second Affiliated Hospital of Guangzhou Medical University · NCT06195293 · Data updated 2026-11-12

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

PhasePhase 1
Study typeInterventional
Ages18 Years to 75 Years
SexAll
Enrollment30 (estimated)
SponsorSecond Affiliated Hospital of Guangzhou Medical University
Academic / other
Drugs / interventionsprednisone, immunotherapy
Locations1 site (Guangzhou)
StatusRecruiting
StartedJune 4, 2024
Main results expectedDecember 30, 2029
Study endsDecember 30, 2037
Registry record updatedJune 26, 2024
Trial IDNCT06195293 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a 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.

Probably 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.

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

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.

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 gone: While this approach is innovative, similar studies using neoantigen vaccines have shown promise in early-phase trials.

Who can join: the full rules

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.

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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 it's running

  • 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.