Anti-cancer Neoantigen Polypeptide Vaccine to Treat Solid Tumors

NCT06195293 | Recruiting Phase 1

• 1 other identifier: ZZVACCINE-POLYPEPTIDE-021
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Solid Tumor, Adult

Keywords

Solid Tumor; Polypeptide Vaccine; Immunotherapy

Outcome Measures

Primary Outcomes (1)

• Number of Patients with Dose Limiting Toxicity

  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.

  Six months

Secondary Outcomes (1)

• Percent of Patients with best response as either complete remission or partial remission.

  Six months

Study Arms (1)

Anti-cancer Neoantigen Polypeptide Vaccine

EXPERIMENTAL

Anti-cancer neoantigen polypeptide vaccine will be produced to treat advanced solid tumors.

Biological: Neoantigen Polypeptide Vaccine

Interventions

Neoantigen Polypeptide Vaccine BIOLOGICAL

Deliver neoantigen polypeptide vaccine into patients for anti-ancer therapy.

Anti-cancer Neoantigen Polypeptide Vaccine

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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.

You may not qualify if:

• Had accepted gene therapy before;
• Severe virus infection such as HBV, HCV, HIV, et al;
• Known HIV positivity;
• Active infectious disease related to bacteria, virus,fungi,et al;
• Other severe diseases that the investigators consider not appropriate;
• Pregnant or lactating women;
• Systemic steroid treatment (greater than or equal to 0.5 mg prednisone equivalent/kg/day);
• Other conditions that the investigators consider not appropriate.

Sponsors & Collaborators

• Second Affiliated Hospital of Guangzhou Medical University: lead

Study Sites (1)

Second Affiliated Hospital of Guangzhou Medical University

Guangzhou, 510260, China

RECRUITING

Study Officials

• Zhenfeng Zhang, MD, PhD

  Second Affiliated Hospital of Guangzhou Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhenfeng Zhang, MD, PhD

CONTACT

0086-020-39195965; zhangzhf@gzhmu.edu.cn

Bingjia He, MD

CONTACT

+862039195965; 464677938@qq.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2023
• First Posted: January 8, 2024
• Study Start: June 4, 2024
• Primary Completion (Estimated): December 30, 2029
• Study Completion (Estimated): December 30, 2037
• Last Updated: June 26, 2024

Record last verified: 2024-06

Locations

CN (1)