Basket Trial of Neoantigen Synthetic Long Peptide Vaccines in Patients With Advanced Malignancy

This is a basket trial of neoantigen synthetic long peptide vaccines in patients with advanced malignancy. Up to 20 subjects will be treated with the neoantigen synthetic long peptide vaccines.

Study Overview

• Status: Enrolling by invitation
• Conditions: Cancer; Solid Tumor
• Intervention / Treatment: Biological: Personalized Synthetic Long Peptide Vaccine

Detailed Description

This is a basket trial of neoantigen synthetic long peptide vaccines in patients with advanced malignancy. Up to 20 subjects will be treated with the neoantigen synthetic long peptide vaccines.

1. To determine the safety of neoantigen synthetic peptide vaccines.
2. To assess the immune response to neoantigen synthetic long peptide vaccines as measured by ELISPOT.

Neoantigen synthetic long peptide vaccines are composed of synthetic long peptides which are 25-30 amino acids in length and designed to induce immune responses to cancer neoantigens identified by exome sequencing. Neoantigen synthetic long peptide vaccines will be co-administered with poly-ICLC, an innate immune adjuvant capable of activating TLR3 and other pathways.

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94115
      • Quest Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 110 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 1. Patients with advanced malignancies and limited treatment options with an estimated 5 year survival of less than 50%. Patient must have advanced solid tumors that have progressed after treatment with standard FDA approved therapies, or for which no effective standard therapy is available, or the subject has a contraindication to standard therapy.

Other Inclusion Criteria:

• 1. >= 18 years of age.
• 2. ECOG performance status ≤ 2
• 3. Adequate organ function allowing favorable benefit to risk ratio per the treating physician
• 4. Systemic corticosteroid therapy is permitted provided dosing is no greater than 4 mg per day (dexamethasone or equivalent) on the day of vaccine administration.
• 5. Ability to understand and willingness to sign an IRB approved written informed consent document.

Exclusion Criteria:

• 1. History of serious adverse reaction to vaccines such as anaphylaxis, hives, or respiratory difficulty or known allergy to a component of the neoantigen synthetic long peptide vaccine.
• 2. Intercurrent illness requiring chronic use of medications that may interfere with rescue medications for treatment of vaccine-related anaphylaxis or attenuate immune response to vaccine treatment (immunosuppressive therapies).
• 3. Psychiatric illness or social situations that would limit compliance with study requirements.
• 4. History of pre-existing immunodeficiency disorder or autoimmune condition requiring immunosuppressive therapy that would preclude response to vaccine.
• 5. Females of childbearing potential may participate provided they agree to practice abstinence; and, if heterosexually active, agree to use at least 2 highly effective contraceptive methods throughout the study and for 3 months following the last dose of study drug; and have a negative serum pregnancy test.
• 6. Females of non-childbearing potential must be post-menopausal or have been surgically sterilized.
• 7. Male subjects with a female partner of childbearing potential must agree to practice abstinence or to use a physician-approved contraceptive method throughout the study and for 3 months following the last dose of study drug.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Personalized Synthetic Long Peptide Vaccine	Biological: Personalized Synthetic Long Peptide Vaccine; Personalized Synthetic Long Peptide Vaccine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To determine the safety of neoantigen synthetic peptide vaccines by rate of serious safety events by CTCAE v5.	The primary objective is to determine the rate of serious safety events	5 years
To assess the immune response to neoantigen synthetic long peptide vaccines as measured by percent of patients with ELISPOT positive response	The secondary outcome is to determine the percent of patients showing an immune response to the vaccine components	5 years

Collaborators and Investigators

• Sponsor: Jaime Leandro Foundation for Therapeutic Cancer Vaccines

Study record dates

Study Major Dates

• Study Start (Actual): November 30, 2022
• Primary Completion (Anticipated): January 1, 2025
• Study Completion (Anticipated): January 1, 2027

Study Registration Dates

• First Submitted: August 16, 2021
• First Submitted That Met QC Criteria: February 20, 2023
• First Posted (Estimate): February 23, 2023

Study Record Updates

• Last Update Posted (Estimate): February 23, 2023
• Last Update Submitted That Met QC Criteria: February 20, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: personalized neoantigen vaccine
• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: JLF-200

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No