A Phase 1b/2, Multi-center, Single Arm Study to Assess the Safety and Efficacy of Neoantigen Synthetic Long Peptide Vaccines in Patients With Local Or Metastatic Solid Tumors

A Phase 1b/2, Multi-center, Single Arm Study to Assess the Safety and Efficacy of Neoantigen Synthetic Long Peptide Vaccines in Patients With Local Or Metastatic Solid Tumors

Study Overview

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

Detailed Description

This is a Simon-two stage multi-cohort study to assess the safety and efficacy of neoantigen synthetic long peptide vaccines in patients with local or metastatic solid tumors.

1. To assess the efficacy of NeoSLP vaccination by investigator assessment of Progression-Free Survival at 12 months (PFS12).
2. To assess efficacy of NeoSLP vaccination by assessment of Time to Treatment Failure (TTF).
3. To assess efficacy of NeoSLP vaccination by assessment of Overall Survival at 24 months (OS24).
4. To investigate the immunogenicity of NeoSLP vaccines by ELISpot assay. 5. To assess the safety and tolerability of NeoSLP vaccines.

• Study Type: Interventional
• Enrollment (Estimated): 136
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Beverly Hills, California, United States, 90212
      • Precision NextGen Oncology & Research Center
    • San Francisco, California, United States, 94115
      • Quest Clinical Research
  • Florida
    • Miami Beach, Florida, United States, 33140
      • Mount Sinai Comprehensive Cancer Center
  • Missouri
    • Bridgeton, Missouri, United States, 63044
      • St. Louis Cancer Care
  • New York
    • New York, New York, United States, 10028
      • Anna Gattani MD PC

Participation Criteria

Eligibility Criteria

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

Description

Patients must satisfy the following criteria to be enrolled in the protocol:

Main Inclusion Criterion:

Pancreatic

1. Patients who have local or metastatic pancreatic adenocarcinoma and have started first line therapy of Folfirinox (physician's choice for any concomitant therapies)
2. Patients who have undergone somatic tumor sequencing should consider FDA-approved pan-solid tumor therapies if they harbor an FDA-approved somatic alteration. For example, Entrectinib or Larotrectinib (if NTRK gene fusion- positive), Selpercatinib (if RET gene fusion-positive), Pembrolizumab (if MSI-H, dMMR, or TMB-H[≥10 mut/Mb]), and PARP inhibitors (BRCA mutations).

Glioblastoma

1. Patients who are within 6 months of diagnosis and have detectable disease as determined by investigator assessment at the start of vaccine administration.

Basket

1. Patients with local or metastatic malignancies, limited treatment options, and an estimated 5-year survival of less than 50% are eligible for enrollment in this cohort.

Other Inclusion Criteria:

1. >= 12 years of age.
2. ECOG performance status ≤ 2 or Karnofsky score of >=70.
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 assess the efficacy of NeoSLP vaccination by investigator assessment of Progression-Free Survival at 12 months (PFS12).	Progression-Free Survival at 12 months (PFS12) defined as time from first vaccine administration until disease progression by investigator assessment or death due to any cause.	Until progression or death, assessed up to 12 months post first vaccine administration.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To assess efficacy of NeoSLP vaccination by assessment of Time to Treatment Failure (TTF).	Time to Treatment Failure (TTF) is defined as time from first vaccine administration to discontinuation of treatment due to any reason, including disease progression, treatment toxicity, and death.	Assessed up to 12 months post first vaccine administration
To assess efficacy of NeoSLP vaccination by assessment of Overall Survival at 24 months (OS24).	Overall Survival at 24 months (OS24) is the landmark of OS defined as the proportion of patients alive at 24 months.	Until death, assessed up to 24 months post first vaccine administration
To assess the safety and tolerability of NeoSLP vaccines.	Adverse Events (AEs) and Severe Adverse Events (SAEs)	Assessed up to 60 days from last vaccine administration

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
To investigate the immunogenicity of NeoSLP vaccines by ELISpot assay.	Immune monitoring is defined as the percentage of patients showing an immune response to the vaccine components.	Assessed at baseline before first vaccine administration and day 50 post

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 (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2029

Study Registration Dates

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

Study Record Updates

• Last Update Posted (Actual): January 15, 2026
• Last Update Submitted That Met QC Criteria: January 13, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

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

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

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