Status:
AVAILABLE
Expanded Access To Neoantigen Synthetic Long Peptide Vaccines in Patients With Local Or Metastatic Solid Tumors
Lead Sponsor:
Jaime Leandro Foundation for Therapeutic Cancer Vaccines
Conditions:
Cancer
Eligibility:
All Genders
12+ years
Brief Summary
This is an intermediate patient expanded access protocol for treatment of patients with local or metastatic solid tumors with a neoantigen synthetic long peptide vaccine.
Eligibility Criteria
Inclusion
- Patients must satisfy the following criteria to be enrolled in the protocol:
- Main Inclusion Criterion:
- 1\. Patient who qualifies for treatment under 21 CFR 312.305 based on treating physician judgment, inability to enroll in study JLF-200, must have received or be ineligible for FDA-approved therapies for their specific cancer type, and an estimated 5-year survival of less than 50%.
- Other
- \>= 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.
Exclusion
- 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. 5. 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.
- 6\. Females of non-childbearing potential must be post-menopausal or have been surgically sterilized.
- 7\. 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.
Key Trial Info
Start Date :
Trial Type :
EXPANDED_ACCESS
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT06963697
Last Update
May 9 2025
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.