Clinical trial · Interventional
Anti-cancer Neoantigen Polypeptide Vaccine to Treat Solid Tumors
Anti-cancer Neoantigen Polypeptide Vaccine to Treat Advanced Solid Tumors: Phase I Clinical Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The WES and RAN-seq will be performed to identify and verify neoantigens and appropriate polypeptide sequences will be verified, manufactured and protected for vaccine production by multiple in vitro and in vivo studies. Clinical studies will be performed to test anti-cancer function of the polypeptide vaccine for immunotherapy of human cancer patients. In this phase I study, the safety, tolerance, and preliminary efficacy of the polypeptide vaccine immunotherapy on human cancers will firstly be evaluated.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Solid Tumor, Adult | Adult Solid Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Neoantigen Polypeptide Vaccine | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Anti-cancer Neoantigen Polypeptide Vaccine
- description
- Anti-cancer neoantigen polypeptide vaccine will be produced to treat advanced solid tumors.
- interventionNames
- Biological: Neoantigen Polypeptide Vaccine
Primary outcomes (1)
- measure
- Number of Patients with Dose Limiting Toxicity
- timeFrame
- Six months
- description
- A dose limiting toxicity is defined as any toxicity that is considered to be primarily related to the vaccine, which is irreversible, or life threatening or hematologic or non-hematologic Grade 3-5.
Secondary outcomes (1)
- measure
- Percent of Patients with best response as either complete remission or partial remission.
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available