To hear about similar clinical trials, please enter your email below
Trial Title:
Basket Trial of Neoantigen Synthetic Long Peptide Vaccines in Patients With Advanced Malignancy
NCT ID:
NCT05741242
Condition:
Cancer
Solid Tumor
Conditions: Official terms:
Neoplasms
Conditions: Keywords:
personalized neoantigen vaccine
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Enrolling by invitation
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
Personalized Synthetic Long Peptide Vaccine
Description:
Personalized Synthetic Long Peptide Vaccine
Arm group label:
Personalized Synthetic Long Peptide Vaccine
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.
Detailed description:
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.
1. To determine the safety of neoantigen synthetic peptide vaccines.
2. To assess the immune response to neoantigen synthetic long peptide vaccines as
measured by ELISPOT.
Neoantigen synthetic long peptide vaccines are composed of synthetic long peptides which
are 25-30 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.
Criteria for 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 ≤ 2
-
3. Adequate organ function allowing favorable benefit to risk ratio per the
treating physician
-
4. 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.
Gender:
All
Minimum age:
12 Years
Maximum age:
110 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Quest Clinical Research
Address:
City:
San Francisco
Zip:
94115
Country:
United States
Start date:
November 30, 2022
Completion date:
January 2027
Lead sponsor:
Agency:
Jaime Leandro Foundation for Therapeutic Cancer Vaccines
Agency class:
Other
Source:
Jaime Leandro Foundation for Therapeutic Cancer Vaccines
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05741242
