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 | Enrolling By Invitation Phase 1 FDA Drug

• 1 other identifier: JLF-200
• Study Type: interventional
• Target: 136
• Locations: 1 country
• Sites: 5

Brief Summary

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

Conditions

Cancer; Solid Tumor

Keywords

personalized neoantigen vaccine

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• To assess efficacy of NeoSLP vaccination by assessment of Time to Treatment Failure (TTF).

  Assessed up to 12 months post first vaccine administration

• To assess efficacy of NeoSLP vaccination by assessment of Overall Survival at 24 months (OS24).

  Until death, assessed up to 24 months post first vaccine administration

• To assess the safety and tolerability of NeoSLP vaccines.

  Assessed up to 60 days from last vaccine administration

Other Outcomes (1)

• To investigate the immunogenicity of NeoSLP vaccines by ELISpot assay.

  Assessed at baseline before first vaccine administration and day 50 post

Study Arms (1)

Personalized Synthetic Long Peptide Vaccine

EXPERIMENTAL

Biological: Personalized Synthetic Long Peptide Vaccine

Interventions

Personalized Synthetic Long Peptide Vaccine BIOLOGICAL

Personalized Synthetic Long Peptide Vaccine

Personalized Synthetic Long Peptide Vaccine

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• \>= 12 years of age.
• ECOG performance status ≤ 2 or Karnofsky score of \>=70.
• Adequate organ function allowing favorable benefit to risk ratio per the treating physician
• Systemic corticosteroid therapy is permitted provided dosing is no greater than 4 mg per day (dexamethasone or equivalent) on the day of vaccine administration.
• Ability to understand and willingness to sign an IRB approved written informed consent document.

You may not qualify if:

• 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.
• 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).
• Psychiatric illness or social situations that would limit compliance with study requirements.
• History of pre-existing immunodeficiency disorder or autoimmune condition requiring immunosuppressive therapy that would preclude response to vaccine.
• 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.
• Females of non-childbearing potential must be post-menopausal or have been surgically sterilized.
• 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.

Sponsors & Collaborators

• Jaime Leandro Foundation for Therapeutic Cancer Vaccines: lead

Study Sites (5)

Precision NextGen Oncology & Research Center

Beverly Hills, California, 90212, United States

Location

Quest Clinical Research

San Francisco, California, 94115, United States

Location

Mount Sinai Comprehensive Cancer Center

Miami Beach, Florida, 33140, United States

Location

St. Louis Cancer Care

Bridgeton, Missouri, 63044, United States

Location

Anna Gattani MD PC

New York, New York, 10028, United States

Location

MeSH Terms

Conditions

Neoplasms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR
• Expanded Access: Yes

Study Record Dates

• First Submitted: August 16, 2021
• First Posted: February 23, 2023
• Study Start: November 30, 2022
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2029
• Last Updated: January 15, 2026

Record last verified: 2026-01

Locations

US (5)