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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Personalized Synthetic Long Peptide Vaccine | Biological | Neoantigen synthetic long peptide vaccines are composed of synthetic long peptides which are 8-35 amino acids in length and designed to induce immune responses to cancer neoantigens identified by exome sequencing. Neoantigen synthetic long peptide vaccines will be co-administered with poly-ICLC, an innate immune adjuvant capable of activating TLR3 and other pathways. |
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 Inclusion Criteria:
Exclusion Criteria:
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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| William Hoos | Contact | info@jaimeleandrofoundation.org |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Texas Oncology | Available | Austin | Texas | 78705 | United States |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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