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

• Sponsor: Jaime Leandro Foundation for Therapeutic Cancer Vaccines (Other)
• Overall Status: Enrolling by invitation
• CT.gov ID: NCT05741242
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 49.1
• Patients Per Site Per Month: 0.4

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Cancer; Solid Tumor	Biological: Personalized Synthetic Long Peptide Vaccine	Phase 1/Phase 2

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 20 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Basket Trial of Neoantigen Synthetic Long Peptide Vaccines in Patients With Advanced Malignancy
• Actual Study Start Date: Nov 30, 2022
• Anticipated Primary Completion Date: Jan 1, 2025
• Anticipated Study Completion Date: Jan 1, 2027

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. To determine the safety of neoantigen synthetic peptide vaccines by rate of serious safety events by CTCAE v5. [5 years]

   The primary objective is to determine the rate of serious safety events

2. To assess the immune response to neoantigen synthetic long peptide vaccines as measured by percent of patients with ELISPOT positive response [5 years]

   The secondary outcome is to determine the percent of patients showing an immune response to the vaccine components

Eligibility Criteria

Criteria

• Ages Eligible for Study: 12 Years to 110 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

• 1. ECOG performance status ≤ 2
• 1. Adequate organ function allowing favorable benefit to risk ratio per the treating physician
• 1. Systemic corticosteroid therapy is permitted provided dosing is no greater than 4 mg per day (dexamethasone or equivalent) on the day of vaccine administration.
• 1. 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.
• 1. 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).
• 1. Psychiatric illness or social situations that would limit compliance with study requirements.
• 1. History of pre-existing immunodeficiency disorder or autoimmune condition requiring immunosuppressive therapy that would preclude response to vaccine.
• 1. 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.
• 1. Females of non-childbearing potential must be post-menopausal or have been surgically sterilized.
• 1. 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Quest Clinical Research	San Francisco	California	United States	94115

Sponsors and Collaborators

• Jaime Leandro Foundation for Therapeutic Cancer Vaccines

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jaime Leandro Foundation for Therapeutic Cancer Vaccines
• ClinicalTrials.gov Identifier: NCT05741242
• Other Study ID Numbers: JLF-200
• First Posted: Feb 23, 2023
• Last Update Posted: Feb 23, 2023
• Last Verified: Feb 1, 2023

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Jaime Leandro Foundation for Therapeutic Cancer Vaccines: personalized neoantigen vaccine
• Additional relevant MeSH terms: Neoplasms

Study Results

No Results Posted as of Feb 23, 2023