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

Completed · Phase 1

Conditions studied: Colorectal Cancer, Gastric Cancer, Pancreatic Cancer, Ovarian Cancer

In brief

This is a Phase 1, open-label, 2-part, multi-center study evaluating the safety, tolerability, PK, pharmacodynamics (PD), immunogenicity, and antitumor activity of CUE-102 intravenous (IV) monotherapy in HLA-A\*0201 positive patients with WT1 positive recurrent/metastatic solid tumors who have failed conventional therapies.

Key facts

Study ID

NCT05360680

Run by

Cue Biopharma

People needed

42

Starts

2022-06-14

Expected to finish

2025-03-12

Last updated by the study team

2026-01-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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:
• A. 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).
• B. 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).
• C. 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).
• D. Ovarian cancer
• 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. (CUE-102 will be 2nd line therapy or greater).
• 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).
• Patient must have HLA-A*0201 genotype as determined by genomic testing.

You may not qualify if…

• 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

Where it is running

• Mayo Clinic — Phoenix, Arizona, United States
• Cedars-Sinai Medical Center — Los Angeles, California, United States
• Stanford Advanced Medicine Cancer Center — Palo Alto, California, United States
• Moffitt Cancer Center — Tampa, Florida, United States
• Winship Cancer Institute — Atlanta, Georgia, United States
• Johns Hopkins University — Baltimore, Maryland, United States
• Mayo Clinic - Rochester — Rochester, Minnesota, United States
• Carol G. Simon Cancer Center - Morristown Medical Center — Morristown, New Jersey, United States
• Montefiore Medical Center — The Bronx, New York, United States
• Carolina BioOncology Institute — Huntersville, North Carolina, United States
• Gabrail Cancer Center — Canton, Ohio, United States
• Cleveland Medical Center (University Hospitals) — Cleveland, Ohio, United States
• MD Anderson Cancer Center — Houston, Texas, United States
• Northwest Medical Specialties, PLLC — Tacoma, Washington, United States
• Carbone Cancer Center — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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