NCT05741242

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

• Status: Enrolling By Invitation
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 136 (estimated)
• Sponsor: Jaime Leandro Foundation for Therapeutic Cancer Vaccines · Academic / Other
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

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

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.

Conditions

• Cancer
• Solid Tumor

Interventions

Type	Name	Description
BIOLOGICAL	Personalized Synthetic Long Peptide Vaccine	Personalized Synthetic Long Peptide Vaccine

Timeline

• Start date: 2022-11-30
• Primary completion: 2027-01-01
• Completion: 2029-01-01
• First posted: 2023-02-23
• Last updated: 2026-01-15

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study