Clinical Trials

Inclusion Criteria:

• 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.
• Age ≥ 18 years old.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Life expectancy ≥ 12 weeks.
• Measurable disease as per RECIST 1.1 and documented by CT and/or MRI.
• All tumors must have histologically or cytologically confirmed cancer diagnosis.
• Patients must have any of the following cancers to be eligible:
  • Colorectal cancer
    • Histologically or cytologically documented adenocarcinoma of colon or rectum at the time of initial presentation;
    • Metastatic or locally advanced/unresectable disease;
    • 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).
  • Gastric cancer (including gastroesophageal junction)
    • Histologically or cytologically documented gastric cancer at the time of initial  presentation;
    • Metastatic or locally advanced/ unresectable disease;
    • Documented disease progression after last administration of standard therapies or intolerance to standard therapies. (CUE-102 will be 2nd line therapy or greater).
  • Pancreatic cancer
    • Histologically or cytologically documented pancreatic adenocarcinoma at the time of initial presentation;
    • Patients with metastatic or locally advanced/unresectable disease;
    • 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).
  • Ovarian cancer (including fallopian tube cancer)
    • Has progressed following at least 1 prior systemic therapy for advanced or metastatic disease (CUE-102 will be 2nd line therapy or greater). Patients with ovarian cancer of germ cell origin are excluded. Patient must meet the following:
      • Histologically or cytologically documented ovarian cancer at the time of initial presentation;
      • Metastatic or locally advanced/unresectable disease, with documented disease progression after last administration of standard therapies or intolerance to standard therapies;
      • Prior systemic treatment must include a platinum-based regimen. 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).
    • For the purposes of this study. platinum-resistant disease is defined as:
      • Progression on primary, maintenance, or recurrent therapy;
      • Stable or persistent disease;
      • Complete remission and relapse < 6 months after completing chemotherapy.
    • Platinum-sensitive disease is defined as:
      • Complete remission and relapse ≥ 6 months after completing chemotherapy.
    • Note: Patients with known:
      • NTRK gene fusions should be offered entrectinib class of drugs prior to being offered CUE-102;
      • MSI-H tumors should be offered a CPI prior to being offered CUE-102;
      • Deleterious germline BRCA1/2 mutations may benefit from poly (ADP-ribose) polymerase inhibitors (PARPi) therapy in relapse or maintenance setting, but prior treatment with a PARPi is not required.
• Patient must have HLA-A*0201 genotype as determined by genomic testing.
• Patient must have histologically and/or cytologically proven tumor(s) that is WT1 positive.
• Acceptable laboratory parameters.
• 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.
• 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.
• 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.

Exclusion Criteria:

• Female patients who are pregnant or plan to become pregnant during the course of the trial.
• Female patients who are breastfeeding.
• Patients with symptomatic central nervous system (CNS) metastases must have been treated, be asymptomatic, and not have any of the following at the time of enrollment:
• Need for concurrent treatment for the CNS disease (e.g., surgery, radiation, corticosteroids > 10 mg prednisone/day or equivalent);
• Progression of CNS metastases on CT or MRI for at least 28 days after last day of prior therapy for the CNS metastases;
• Concurrent leptomeningeal disease or cord compression;
• Has an active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids, or  immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is permitted;
• History of prior allogeneic bone marrow, stem-cell, or solid organ transplantation;
• Treatment with any systemic anti-neoplastic therapy, or investigational therapy within the 14 days (or 28 days, for antibody drugs), before the first dose of CUE-102;
• Treatment with radiation therapy within 14 days before the first dose of CUE-102;
• Treatment with corticosteroids (> 10 mg per day prednisone or equivalent) or other immune suppressive drugs within 14 days before the first dose of CUE-102. Steroids for topical, ophthalmic, inhaled, or nasal administration are permitted. Physiological replacement with up to a maximum dose of 5 mg equivalence of prednisone per day is permitted;
• History of clinically significant cardiovascular disease; 
• Clinically significant pulmonary compromise (e.g., requirement for supplemental oxygen);
• Clinically significant gastrointestinal (GI) disorders.
• Patients who experienced the following immune CPI-related AEs are ineligible even if the AE resolved to ≤ Grade 1 or baseline:
  • ≥ Grade 3 ocular AE;
  • Changes in liver function tests that met the criteria for Hy's Law (> 3 × ULN of either ALT/AST with concurrent > 2 × ULN of total bilirubin (total and direct) and without alternate etiology);
  • ≥ Grade 3 neurologic toxicity;
  • ≥ Grade 3 colitis;
  • ≥ Grade 3 renal toxicity.
• Evidence of active viral, bacterial, or systemic fungal infection requiring parenteral treatment within 7 days before the first dose of CUE-102.
• 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.
• Second primary invasive malignancy that has not been in remission for > 2 years.
• History of trauma or major surgery within 28 days before the first dose of CUE-102.
• Any serious underlying medical or psychiatric condition that would impair the ability of the patient to receive or tolerate the planned treatment at the investigational site.
• Known hypersensitivity to recombinant proteins, polysorbate 80 or any excipient contained in the drug formulation for CUE-102.
• Vaccination with any live virus vaccine within 28 days before the first dose of CUE-102. Inactivated annual influenza vaccination is allowed.
• Dementia or altered mental status that would preclude understanding and rendering of informed consent.
• Active or history of significant alcohol or other substance abuse within 1 year before the first dose of CUE-102.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 12/27/23. Questions regarding updates should be directed to the study team contact.