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 toinitiation of any study-related tests or procedures that are not part of standard ofcare 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

8. Histologically or cytologically documented adenocarcinoma of colon or rectum atthe time of initial presentation

9. Metastatic or locally advanced/unresectable disease

10. Documented disease progression after the last administration of standardtherapies 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)

11. Histologically or cytologically documented gastric cancer at the time ofinitial presentation

12. Metastatic or locally advanced/unresectable disease

13. Documented disease progression after last administration of standard therapiesor intolerance to standard therapies. (CUE-102 will be 2nd line therapy orgreater). C. Pancreatic cancer

14. Histologically or cytologically documented pancreatic adenocarcinoma at thetime of initial presentation

15. Patients with metastatic or locally advanced/unresectable disease.

16. Prior systemic treatment must include either a fluoropyrimidine-based orgemcitabine-based regimen in either the (neo)adjuvant or relapsed setting. (CUE-102 will be 2nd line therapy or greater). D. Ovarian cancer

17. Histologically or cytologically documented ovarian cancer at the time ofinitial presentation

18. Metastatic or locally advanced/unresectable disease, with documented diseaseprogression after last administration of standard therapies or intolerance tostandard therapies.

19. Prior systemic treatment must include a platinum-based regimen. (CUE-102 willbe 2nd line therapy or greater).

20. For patients determined to have platinum-sensitive disease, treatment with asecond platinum-based combination regimen +/- bevacizumab should be consideredprior to treatment with CUE-102 (CUE-102 will be 3rd line therapy or greater).

21. Patient must have HLA-A*0201 genotype as determined by genomic testing.

22. Patient must have histologically and/or cytologically proven tumor(s) that is WT1positive.

23. Acceptable laboratory parameters.

24. Female patients of childbearing potential must agree to use acceptable contraceptivemeasures from the time of main study consent through 90 days after discontinuationof study drug administration.

25. Non-vasectomized male patients with partners of childbearing potential must usebarrier contraception from the time of main study consent through 90 days afterdiscontinuation of study drug.

26. Patients who have previously received an immune CPI (e.g., anti-programmed celldeath 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 musthave toxicities related to the CPI resolved to CTCAE ≤ Grade 1 or baseline (levelprior to the CPI) to be eligible for enrollment. Patients who have experiencedCPI-related endocrinopathies (e.g., diabetes, adrenal insufficiency) may participateif endocrinopathies are controlled (CTCAE ≤ Grade 1) with endocrinology support andappropriate repletion. Note: Patients who experienced previous hypothyroidismtoxicity on a CPI are eligible to enter study regardless of CTCAE grade resolutionas long as the patient is well controlled on thyroid replacement hormone.

Exclusion Criteria:

1. Female patients who are pregnant or plan to become pregnant during the course of thetrial

2. Female patients who are breastfeeding

3. Patients with symptomatic central nervous system (CNS) metastases must have beentreated, be asymptomatic, and not have any of the following at the time ofenrollment:

4. Need for concurrent treatment for the CNS disease (e.g., surgery, radiation,corticosteroids >10 mg prednisone/day or equivalent)

5. Progression of CNS metastases on CT or MRI for at least 28 days after last dayof prior therapy for the CNS metastases

6. Concurrent leptomeningeal disease or cord compression.

7. Has an active autoimmune disease that has required systemic treatment in past 2years (i.e., with use of disease modifying agents, corticosteroids, orimmunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, orphysiologic corticosteroid replacement therapy for adrenal or pituitaryinsufficiency) is not considered a form of systemic treatment and is permitted.

8. History of prior allogeneic bone marrow, stem-cell, or solid organ transplantation

9. Treatment with any systemic anti-neoplastic therapy, or investigational therapywithin the 14 days (or 28 days, for antibody drugs), before the first dose ofCUE-102.

10. Treatment with radiation therapy within 14 days before the first dose of CUE-102

11. Treatment with corticosteroids (> 10 mg per day prednisone or equivalent) or otherimmune suppressive drugs within 14 days before the first dose of CUE-102. Steroidsfor topical, ophthalmic, inhaled, or nasal administration are permitted.Physiological replacement with up to a maximum dose of 5 mg equivalence ofprednisone per day is permitted.

12. History of clinically significant cardiovascular disease

13. Clinically significant pulmonary compromise (e.g., requirement for supplementaloxygen)

14. Clinically significant gastrointestinal (GI) disorders

15. Patients who experienced the following immune CPI-related AEs are ineligible even ifthe AE resolved to ≤ Grade 1 or baseline:

16. ≥ Grade 3 ocular AE

17. Changes in liver function tests that met the criteria for Hy's Law (> 3× ULN ofeither ALT/AST with concurrent > 2× ULN of total bilirubin (total and direct)and without alternate etiology)

18. ≥ Grade 3 neurologic toxicity

19. ≥ Grade 3 colitis

20. ≥ Grade 3 renal toxicity

21. Evidence of active viral, bacterial, or systemic fungal infection requiringparenteral treatment within 7 days before the first dose of CUE-102.

22. No known history of infection or positive test for HIV, Hepatitis B or Hepatitis C,testing prior to enrollment is not required unless mandated by local authority

23. Second primary invasive malignancy that has not been in remission for > 2 years.

24. History of trauma or major surgery within 28 days before the first dose of CUE-102

25. Any serious underlying medical or psychiatric condition that would impair theability of the patient to receive or tolerate the planned treatment at theinvestigational site

26. Known hypersensitivity to recombinant proteins, polysorbate 80 or any excipientcontained in the drug formulation for CUE-102

27. Vaccination with any live virus vaccine within 28 days before the first dose ofCUE-102. Inactivated annual influenza vaccination is allowed.

28. Dementia or altered mental status that would preclude understanding and rendering ofinformed consent

29. Active or history of significant alcohol or other substance abuse within 1 yearbefore the first dose of CUE-102