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

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05741242
• Other study ID #: JLF-200
• Status: Enrolling by invitation
• Phase: Phase 1/Phase 2
• Start date: November 30, 2022
• Est. completion date: January 2027

Study information

• Verified date: February 2023
• Source: Jaime Leandro Foundation for Therapeutic Cancer Vaccines
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 20
• Est. completion date: January 2027
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 110 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cancer
• Neoplasms
• Solid Tumor

Intervention

Biological:
• Personalized Synthetic Long Peptide Vaccine
Personalized Synthetic Long Peptide Vaccine

Locations

Country	Name	City	State
United States	Quest Clinical Research	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
Jaime Leandro Foundation for Therapeutic Cancer Vaccines

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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