A Phase 1 in Patients With HLA-A*0201+ and WT1+ Recurrent/Metastatic Cancers

Inclusion Criteria

• •1. Ability to provide informed consent and documentation of informed consent prior to initiation of any study-related tests or procedures that are not part of standard of care for the patient's disease.
• •2. Age ≥18 years old
• •3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• •4. Life expectancy ≥12 weeks
• •5. Measurable disease as per RECIST 1.1 and documented by CT and/or MRI.
• •6. All tumors must have histologically or cytologically confirmed cancer diagnosis
• •7. Patients must have any of the following cancers to be eligible:
• •A. Colorectal cancer
• •1. Histologically or cytologically documented adenocarcinoma of colon or rectum at the time of initial presentation
• •2. Metastatic or locally advanced/unresectable disease
• •3. Documented disease progression after the last administration of standard therapies or intolerance to at least 2 prior systemic treatment regimens (CUE-102 will be 3rd line therapy or greater).
• •B. Gastric cancer (including gastroesophageal junction)
• •1. Histologically or cytologically documented gastric cancer at the time of initial presentation
• •2. Metastatic or locally advanced/unresectable disease
• •3. Documented disease progression after last administration of standard therapies or intolerance to standard therapies. (CUE-102 will be 2nd line therapy or greater).
• •C. Pancreatic cancer
• •1. Histologically or cytologically documented pancreatic adenocarcinoma at the time of initial presentation
• •2. Patients with metastatic or locally advanced/unresectable disease.
• •3. Prior systemic treatment must include either a fluoropyrimidine-based or gemcitabine-based regimen in either the (neo)adjuvant or relapsed setting. (CUE-102 will be 2nd line therapy or greater).
• •D. Ovarian cancer
• •1. Histologically or cytologically documented ovarian cancer at the time of initial presentation
• •2. Metastatic or locally advanced/unresectable disease, with documented disease progression after last administration of standard therapies or intolerance to standard therapies.
• •3. Prior systemic treatment must include a platinum-based regimen. (CUE-102 will be 2nd line therapy or greater).
• •4. For patients determined to have platinum-sensitive disease, treatment with a second platinum-based combination regimen +/- bevacizumab should be considered prior to treatment with CUE-102 (CUE-102 will be 3rd line therapy or greater).
• •8. Patient must have HLA-A\*0201 genotype as determined by genomic testing.
• •9. Patient must have histologically and/or cytologically proven tumor(s) that is WT1 positive.
• •10. Acceptable laboratory parameters.
• •11. Female patients of childbearing potential must agree to use acceptable contraceptive measures from the time of main study consent through 90 days after discontinuation of study drug administration.
• •12. Non-vasectomized male patients with partners of childbearing potential must use barrier contraception from the time of main study consent through 90 days after discontinuation of study drug.
• •13. Patients who have previously received an immune CPI (e.g., anti-programmed cell death ligand 1 (anti PD-L1), anti-programmed cell death 1 (anti-PD-1), anti-cytotoxic T lymphocyte-associated antigen 4 \[CTLA-4\]) prior to enrollment must have toxicities related to the CPI resolved to CTCAE ≤ Grade 1 or baseline (level prior to the CPI) to be eligible for enrollment. Patients who have experienced CPI-related endocrinopathies (e.g., diabetes, adrenal insufficiency) may participate if endocrinopathies are controlled (CTCAE ≤ Grade 1) with endocrinology support and appropriate repletion. Note: Patients who experienced previous hypothyroidism toxicity on a CPI are eligible to enter study regardless of CTCAE grade resolution as long as the patient is well controlled on thyroid replacement hormone.