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

Patients must satisfy the following criteria to be enrolled in the protocol:

Main Inclusion Criterion:

Pancreatic

1. Patients who have local or metastatic pancreatic adenocarcinoma and have startedfirst line therapy of Folfirinox (physician's choice for any concomitant therapies)

2. Patients who have undergone somatic tumor sequencing should consider FDA-approvedpan-solid tumor therapies if they harbor an FDA-approved somatic alteration. Forexample, 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 asdetermined by investigator assessment at the start of vaccine administration.

Basket

1. Patients with local or metastatic malignancies, limited treatment options, and anestimated 5-year survival of less than 50% are eligible for enrollment in thiscohort.

Other Inclusion Criteria:

1. >= 12 years of age.

2. ECOG performance status ≤ 2 or Karnofsky score of >=70.

3. Adequate organ function allowing favorable benefit to risk ratio per the treatingphysician

4. Systemic corticosteroid therapy is permitted provided dosing is no greater than 4 mgper day (dexamethasone or equivalent) on the day of vaccine administration.

5. Ability to understand and willingness to sign an IRB approved written informedconsent document.

Exclusion Criteria:

1. History of serious adverse reaction to vaccines such as anaphylaxis, hives, orrespiratory difficulty or known allergy to a component of the neoantigen syntheticlong peptide vaccine.

2. Intercurrent illness requiring chronic use of medications that may interfere withrescue medications for treatment of vaccine-related anaphylaxis or attenuate immuneresponse to vaccine treatment (immunosuppressive therapies).

3. Psychiatric illness or social situations that would limit compliance with studyrequirements.

4. History of pre-existing immunodeficiency disorder or autoimmune condition requiringimmunosuppressive therapy that would preclude response to vaccine.

5. Females of childbearing potential may participate provided they agree to practiceabstinence; and, if heterosexually active, agree to use at least 2 highly effectivecontraceptive methods throughout the study and for 3 months following the last doseof study drug; and have a negative serum pregnancy test.

6. Females of non-childbearing potential must be post-menopausal or have beensurgically sterilized.

7. Male subjects with a female partner of childbearing potential must agree to practiceabstinence or to use a physician-approved contraceptive method throughout the studyand for 3 months following the last dose of study drug.