Clinical Study of a Personalized Neoantigen Cancer Vaccine in Treating Patients With Advanced Malignant Tumor

NCT03662815 | Unknown Phase 1

• 1 other identifier: INEO-P-002
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This research study is evaluating a new type of cancer vaccine called "Personalized Neoantigen Cancer Vaccine" as a possible treatment for advanced malignant tumor. The purpose of the clinical study is evaluating the safety, tolerability and partial efficacy of the personalized neoantigen cancer vaccine in the treatment of Chinese patients with advanced malignant cancer, so as to provide a new personalized therapeutic strategy for advanced pancreatic cancer patients. It is known that cancer patients have mutations (changes in genetic material) that are specific to an individual patient and tumor. These mutations can cause the tumor cells to produce proteins that appear very different from the body's own cells. It is possible that these proteins used in a vaccine may induce strong immune responses, which may help the participant's body fight any tumor cells that could cause the cancer to come back in the future. The study will examine the safety of the vaccine when given at several different time points and will examine the participant's blood cells for signs that the vaccine induced an immune response.

Conditions

Advanced Malignant Solid Tumor

Keywords

Neoantigen; iNeo-Vac-P01; Peptide Vaccine

Outcome Measures

Primary Outcomes (2)

• Objective Response Rate

  2 years

• Number of participants experiencing clinical and laboratory adverse events (AEs)

  1 year

Secondary Outcomes (2)

• Overall Survival Rate

  2 years

• Progression Free Survival

  2 years

Other Outcomes (3)

• Measurement of CD4/CD8 T lymphocyte subsets

  2 years

• The polypeptide antigen - induced IFN-γ T cells responses

  2 years

• Peripheral blood T cell receptor sequencing analysis

  2 years

Study Arms (1)

iNeo-Vac-P01

EXPERIMENTAL

Personal Cancer Vaccine: iNeo-Vac-P01 (peptides)+ GM-CSF; Peptides: 0.1 or 0.3 mg per peptide given on days 1, 4, 8, 15, 22, 78, and 162 for a total of 7 doses. Additional booster vaccines might be administered depending on ethics and patients' potential benefit. GM-CSF: 40 mcg given 30 minutes before iNeo-Vac-P01.

Biological: iNeo-Vac-P01; Other: GM-CSF

Interventions

iNeo-Vac-P01 BIOLOGICAL

Neoantigen peptides

iNeo-Vac-P01

GM-CSF OTHER

immune adjuvant

Also known as: granulocyte-macrophage colony stimulating factor

iNeo-Vac-P01

Eligibility Criteria

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

You may qualify if:

• Must freely sign informed consent;
• Aged 18 to 75 years old;
• The expected survival period is more than 6 months;
• ECOG score is 0 or 1;
• Patients with advanced tumors who fail to receive standard therapy, and those who are not suitable or refuse standard adjuvant therapy;
• Advanced malignant cancer diagnosed by pathology and imageology;
• At least one measurable lesions;
• To be able to obtain sufficient tumor tissue samples and blood samples for analysis, or to have genomic/exon/transcriptional data of tumor tissues and normal tissues, and the data meet the analysis requirements;
• The main organs function is normal, such as the heart, liver and kidney;
• Haematological index:
• neutrophil count≥1.5×109/L
• hemoglobin≥10g/dL
• platelet count≥100×109/L
• Biochemical index:
• Total bilirubin is less than or equal to 1.5 times the upper limit of normal value (ULN)

You may not qualify if:

• Diagnosed as other malignant tumor, but cured basal cell carcinoma, thyroid carcinoma, cervical dysplasia etc is excluded;
• No neoantigen was found in the sequencing data;
• There have been bone marrow or stem cell transplants;
• Systemic cancer treatment or other drugs under study were treated within 4 weeks prior to individualized tumor targeted polypeptides treatment;
• Received other polypeptide inoculation 4 weeks before treatment; Patients may not be vaccinated with other polypeptides 8 weeks after the last individualized tumor targeted polypeptides trentment;
• Active bacterial or fungal infections identified clinically (\>= level 2 of NCI-CTC edition 3);
• Patients with HIV, HCV, HBV infection, severe asthma, autoimmune disease, immunodeficiency or treated with immunosuppressive drugs;
• People infected with herpes virus (scabbed for more than 4 weeks is excluded);
• People infected with respiratory virus (cured for more than 4 weeks is excluded);
• Drug abuse, Clinical, psychological or social factor result in affecting informed consent or research implementation;
• Have a history of drug or polypeptide allergies, or people who are allergic to other potential immunotherapies.

Sponsors & Collaborators

• Sir Run Run Shaw Hospital: lead
• Hangzhou Neoantigen Therapeutics Co., Ltd.: collaborator

Study Sites (1)

Sir Run Run Shaw Hospital

Hangzhou, Zhejiang, 310000, China

Location

Related Publications (4)

• Weden S, Klemp M, Gladhaug IP, Moller M, Eriksen JA, Gaudernack G, Buanes T. Long-term follow-up of patients with resected pancreatic cancer following vaccination against mutant K-ras. Int J Cancer. 2011 Mar 1;128(5):1120-8. doi: 10.1002/ijc.25449.

  PMID: 20473937 BACKGROUND

• Ott PA, Hu Z, Keskin DB, Shukla SA, Sun J, Bozym DJ, Zhang W, Luoma A, Giobbie-Hurder A, Peter L, Chen C, Olive O, Carter TA, Li S, Lieb DJ, Eisenhaure T, Gjini E, Stevens J, Lane WJ, Javeri I, Nellaiappan K, Salazar AM, Daley H, Seaman M, Buchbinder EI, Yoon CH, Harden M, Lennon N, Gabriel S, Rodig SJ, Barouch DH, Aster JC, Getz G, Wucherpfennig K, Neuberg D, Ritz J, Lander ES, Fritsch EF, Hacohen N, Wu CJ. An immunogenic personal neoantigen vaccine for patients with melanoma. Nature. 2017 Jul 13;547(7662):217-221. doi: 10.1038/nature22991. Epub 2017 Jul 5.

  PMID: 28678778 BACKGROUND

• Shou J, Mo F, Zhang S, Lu L, Han N, Liu L, Qiu M, Li H, Han W, Ma D, Guo X, Guo Q, Huang Q, Zhang X, Ye S, Pan H, Chen S, Fang Y. Combination treatment of radiofrequency ablation and peptide neoantigen vaccination: Promising modality for future cancer immunotherapy. Front Immunol. 2022 Sep 29;13:1000681. doi: 10.3389/fimmu.2022.1000681. eCollection 2022.

  PMID: 36248865 DERIVED

• Fang Y, Mo F, Shou J, Wang H, Luo K, Zhang S, Han N, Li H, Ye S, Zhou Z, Chen R, Chen L, Liu L, Wang H, Pan H, Chen S. A Pan-cancer Clinical Study of Personalized Neoantigen Vaccine Monotherapy in Treating Patients with Various Types of Advanced Solid Tumors. Clin Cancer Res. 2020 Sep 1;26(17):4511-4520. doi: 10.1158/1078-0432.CCR-19-2881. Epub 2020 May 21.

  PMID: 32439700 DERIVED

MeSH Terms

Interventions

Granulocyte-Macrophage Colony-Stimulating Factor; Colony-Stimulating Factors

Intervention Hierarchy (Ancestors)

Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: September 5, 2018
• First Posted: September 7, 2018
• Study Start: February 7, 2018
• Primary Completion: May 20, 2021
• Study Completion: December 30, 2022
• Last Updated: November 16, 2021

Record last verified: 2021-11

Locations

CN (1)