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

Advanced Malignant Solid Tumor Clinical Trial

Official title:

Safety, Tolerability and Partial Efficacy Study of a Personalized Neoantigen Cancer Vaccine inTreating Patients With Advanced Malignant Tumor

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03662815
• Other study ID #: INEO-P-002
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: February 7, 2018
• Est. completion date: December 30, 2022

Study information

• Verified date: November 2021
• Source: Sir Run Run Shaw Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: December 30, 2022
• Est. primary completion date: May 20, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• 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) AST and ALT is less than or equal to 2.5 times the upper limit of normal value Serum creatinine and urea nitrogen (BUN) is less than or equal to 1.5 times the upper limit of normal value

• Pregnant, lactating women and women of child-bearing age must have a negative pregnancy test within 7 days before entering the group, and short-term have no fertility plan, and are willing to take protective measures (contraception or other birth control methods) before and during the clinical trial;
• Good compliance, able to follow research protocols and follow-up procedures.

Exclusion Criteria:

• 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);
• Severe coronary or cerebrovascular disease, or other diseases that the investigators considered should to be exclusion;
• 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.

Related Conditions & MeSH terms

• Advanced Malignant Solid Tumor
• Neoplasms

Intervention

Biological:
• iNeo-Vac-P01
Neoantigen peptides

Other:
• GM-CSF
immune adjuvant

Locations

Country	Name	City	State
China	Sir Run Run Shaw Hospital	Hangzhou	Zhejiang

Sponsors (2)

Lead Sponsor	Collaborator
Sir Run Run Shaw Hospital	Hangzhou Neoantigen Therapeutics Co., Ltd.

Country where clinical trial is conducted

China, 

References & Publications (2)

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. Erratum in: Nature. 2018 Mar 14;555(7696):402. — View Citation

Wedén S, Klemp M, Gladhaug IP, Møller 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Measurement of CD4/CD8 T lymphocyte subsets		2 years
Other	The polypeptide antigen - induced IFN-? T cells responses		2 years
Other	Peripheral blood T cell receptor sequencing analysis		2 years
Primary	Objective Response Rate		2 years
Primary	Number of participants experiencing clinical and laboratory adverse events (AEs)		1 year
Secondary	Overall Survival Rate		2 years
Secondary	Progression Free Survival		2 years