Pilot Study of Neoantigen Peptides for the Treatment of Neoplasms

NCT04509167 | Completed Early Phase 1

• 1 other identifier: PEP-NEO-001
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This research is a pilot clinical trial using personalized neoantigen peptide vaccines with an adjuvant (Montanide ISA-51 VG), in patients with different types of cancer

Conditions

Neoplasms

Keywords

tumor; cancer

Outcome Measures

Primary Outcomes (2)

• Change from Baseline in WBC count at 2, 6, 12 months

  WBC quantification in blood and comparison at different timepoints

  Baseline, 2, 6, 12 months

• Change from Baseline in RBC count at 2, 6, 12 months

  RBC quantification in blood and comparison at different timepoints

  Baseline, 2, 6, 12 months

Secondary Outcomes (5)

• Change from Baseline in Calcitonin levels at 2, 6, 12 months

  Baseline, 2, 6, 12 months

• Change from Baseline in CA-125 levels at 2, 6, 12 months

  Baseline, 2, 6, 12 months

• Change from Baseline in beta-2-microglobulin levels at 2, 6, 12 months

  Baseline, 2, 6, 12 months

• Change from Baseline in sum of diameter of target lesions at 2, 6, 12 months

  Baseline, 2, 6, 12 months

• Change from Baseline in sum of diameter of non-target lesions at 2, 6, 12 months

  Baseline, 2, 6, 12 months

Study Arms (1)

Treatment

EXPERIMENTAL

Patients will receive intradermal injection of individualized neoantigen peptides vaccine at a dose of \~500ug per peptide once a week for 8 weeks.

Biological: Neoantigen Peptides

Interventions

Neoantigen Peptides BIOLOGICAL

Patients will receive intradermal injection of individualized neoantigen peptides vaccine at a dose of \~500ug per peptide once a week for 8 weeks.

Treatment

Eligibility Criteria

• Age: 16 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or older, male or female
• Life expectancy of at least 3 months
• Confirmed tumor by imaging studies
• Have adequate organ function, as measured by laboratory values: Lymphocyte ratio \>20%; WBC \>3.0×10\^9/L; alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 × ULN; if the patient has liver metastases, ALT and AST ≤5 × ULN; Alkaline phosphatase (ALP）≤2.5 × ULN; total serum bilirubin (TBIL) \< 1.5 × ULN; Urea nitrogen (BUN）≤1.5 × ULN; Creatinine (Cr）1.5≤ULN; Normal blood coagulation function, urine routine, and electrocardiogram (ECG)
• Available tumor specimen for sequencing and neoantigen determination
• Ability to find 3 or more neoantigen epitopes
• Ability to follow research and follow-up procedures
• Able to understand and willing to sign an IRB approved written informed consent document
• Agree with the use of contraception or partner of child-bearing potential agrees to use adequate contraception which will include two of the following: hormonal or barrier method of birth control, or abstinence prior to study entry, for the duration of study participation, and for 30 days following completion of therapy

You may not qualify if:

• History of immunodeficiency disorder or autoimmune condition requiring active immunosuppressive therapy
• Evidence of Liver and kidney dysfunction, severe heart disease, or coagulation dysfunction
• Known diagnosis of an infectious condition including hepatitis, HIV, CMV, and Treponema pallidum
• Participant becomes pregnant and/or is breastfeeding or plans on becoming pregnant during study

Sponsors & Collaborators

• Instituto de Medicina Regenerativa: lead

Study Sites (1)

Instituto de Medicina Regenerativa

Tijuana, Estado de Baja California, 22100, Mexico

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

• Jesus Perez, MD

  Instituto de Medicina Regenerativa

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: August 8, 2020
• First Posted: August 11, 2020
• Study Start: August 10, 2020
• Primary Completion: June 24, 2022
• Study Completion: June 24, 2022
• Last Updated: March 6, 2024

Record last verified: 2024-03

Locations

ME (1)