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

Part of paid clinical trials in Beverly Hills, California.

Sponsor
Jaime Leandro Foundation for Therapeutic Cancer Vaccines
Study ID
NCT05741242
Phase
PHASE1/PHASE2
Status
Enrolling By Invitation

Conditions

  • Cancer
  • Solid Tumor

Eligibility Criteria

Sex
ALL
Age
12 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Personalized Synthetic Long Peptide Vaccine — BIOLOGICAL
    Personalized Synthetic Long Peptide Vaccine

Study Details

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

Key Dates

Start date
Nov 30, 2022
Status verified
Jan 2026
Primary completion
Jan 31, 2027
Completion
Jan 31, 2029

Study Design

Enrollment
136 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Personalized Synthetic Long Peptide Vaccine

Primary Outcome Measure

To assess the efficacy of NeoSLP vaccination by investigator assessment of Progression-Free Survival at 12 months (PFS12). [ Time Frame: Until progression or death, assessed up to 12 months post first vaccine administration. ]

Locations (5)

FacilityCityStateZIPSite coordinators
Precision NextGen Oncology & Research CenterBeverly HillsCalifornia90212-
Quest Clinical ResearchSan FranciscoCalifornia94115-
Mount Sinai Comprehensive Cancer CenterMiami BeachFlorida33140-
St. Louis Cancer CareBridgetonMissouri63044-
Anna Gattani MD PCNew YorkNew York10028-

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