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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 | Clinical Trials | Clareo Health

ENROLLING_BY_INVITATIONPHASE1/PHASE2

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

NCT05741242•Jaime Leandro Foundation for Therapeutic Cancer Vaccines

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

12 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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.
•1. \>= 12 years of age.
+4 more criteria

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.

Locations (5)

Precision NextGen Oncology & Research Center

Beverly Hills, California, United States

Quest Clinical Research

San Francisco, California, United States

Mount Sinai Comprehensive Cancer Center

Miami Beach, Florida, United States

St. Louis Cancer Care

Bridgeton, Missouri, United States

Anna Gattani MD PC

New York, New York, United States

Key Dates

Start Date

November 30, 2022

Primary Completion Date

January 1, 2027

Completion Date

January 1, 2029

Last Updated

January 15, 2026

Enrollment

136

ESTIMATED participants

Conditions

CancerSolid Tumor

Interventions

Personalized Synthetic Long Peptide Vaccine

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 15, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Testing Olaparib in Patients With Advanced or Metastatic (Cancer That Has Spread) Bladder Cancer and Other Genitourinary Tumors With DNA-Repair Genetic Changes

Testing the Combination of Two Anti-cancer Drugs, DS-8201a and AZD6738, for The Treatment of Advanced Solid Tumors Expressing the HER2 Protein or Gene, The DASH Trial

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