NCT05741242Enrolling by invitationPhase 1/2
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
Source: ClinicalTrials.gov · Last updated 29 Sept 2026
Brief summary (registry, in English)
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 (registry)
- Enrolling by invitation
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 136 (estimated)
- First submitted
- 16 Aug 2021
- Start date
- 30 Nov 2022
- Primary completion date
- Jan 2027
- Lead sponsor
- Jaime Leandro Foundation for Therapeutic Cancer Vaccines
- Diseases
- Childhood cancers
- NCT number
- NCT05741242
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 136
- From 30 Nov 2022 to the primary completion date, Jan 2027
- 6 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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.
Lab values
- 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.
Other
- Females of non-childbearing potential must be post-menopausal or have been surgically sterilized.
Criteria the registry did not label
- Patients must satisfy the following criteria to be enrolled in the protocol:
- Main Inclusion Criterion:
- Pancreatic
- Patients who have local or metastatic pancreatic adenocarcinoma and have started first line therapy of Folfirinox (physician's choice for any concomitant therapies)
- 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.
- Other Inclusion Criteria:
- \>= 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.
Age in the registry: 12 years to - · Sex: All · Does not accept healthy volunteers
Sites (6)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Precision NextGen Oncology & Research Center Coordinator of this site? Confirm its status | Beverly Hills | United States | Unknown status |
| St. Louis Cancer Care Coordinator of this site? Confirm its status | Bridgeton | United States | Unknown status |
| Mount Sinai Comprehensive Cancer Center Coordinator of this site? Confirm its status | Miami Beach | United States | Unknown status |
| Anna Gattani MD PC Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Quest Clinical Research Coordinator of this site? Confirm its status | San Francisco | United States | Unknown status |
| Asthra Health Coordinator of this site? Confirm its status | Santa Monica | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.