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Enrolling By Invitation NCT05741242

Basket Trial of Neoantigen Synthetic Long Peptide Vaccines in Patients With Advanced Malignancy

Conditions: Cancer, Solid Tumor

Sex: All
Ages: 12 Years – 110 Years
Phase: PHASE1, PHASE2
Enrollment: 20
Sponsor: Jaime Leandro Foundation for Therapeutic Cancer Vaccines

Location: United States

Summary

This is a basket trial of neoantigen synthetic long peptide vaccines in patients with advanced malignancy. Up to 20 subjects will be treated with the neoantigen synthetic long peptide vaccines.

Eligibility Criteria

Inclusion Criteria:1. Patients with advanced malignancies and limited treatment options with an estimated 5 year survival of less than 50%. Patient must have advanced solid tumors that have progressed after treatment with standard FDA approved therapies, or for which no effective standard therapy is available, or the subject has a contraindication to standard therapy.Other Inclusion Criteria:1. >= 18 years of age.2. ECOG performance status ≤ 23. Adequate organ function allowing favorable benefit to risk ratio per the treating physician4. Systemic corticosteroid therapy is permitted provided dosing is no greater than 4 mg per day (dexamethasone or equivalent) on the day of vaccine administration.5. Ability to understand and willingness to sign an IRB approved written informed consent document.Exclusion Criteria:1. 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.2. 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).3. Psychiatric illness or social situations that would limit compliance with study requirements.4. 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.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05741242). StuddyBuddy aggregates publicly available trial information.