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 — BIOLOGICALPersonalized 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)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Precision NextGen Oncology & Research Center | Beverly Hills | California | 90212 | - |
| Quest Clinical Research | San Francisco | California | 94115 | - |
| Mount Sinai Comprehensive Cancer Center | Miami Beach | Florida | 33140 | - |
| St. Louis Cancer Care | Bridgeton | Missouri | 63044 | - |
| Anna Gattani MD PC | New York | New York | 10028 | - |
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