A Phase 1 in Patients With HLA-A*0201+ and WT1+ Recurrent/Metastatic Cancers (NCT05360680) | Clinical Trial Compass
CompletedPhase 1
A Phase 1 in Patients With HLA-A*0201+ and WT1+ Recurrent/Metastatic Cancers
United States42 participantsStarted 2022-06-14
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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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:
✓. Histologically or cytologically documented adenocarcinoma of colon or rectum at the time of initial presentation
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