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Brief Title: A Phase 1 in Patients With HLA-A*0201+ and WT1+ Recurrent/Metastatic Cancers
Official Title: A Phase 1, Open-Label, Dose Escalation and Expansion Study of CUE-102 Monotherapy in HLA-A*0201 Positive Patients With WT1 Positive Recurrent/Metastatic Cancers
Study ID: NCT05360680
Brief 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.
Detailed Description: CUE-102 is a novel fusion protein developed for the treatment of patients with WT1-positive malignancies by selective engagement and expansion of tumor antigen-specific T cells that should allow for increased potential for anti-cancer efficacy and reduced toxicity relative to non-targeted forms of immunotherapy that result in systemic activation of the immune system. The goal of Part A is to characterize the safety, tolerability, and biological effects of CUE-102. The goal of Part B is to expand the safety and immune activity data at the RP2D identified in Part A, and to evaluate antitumor activity at this dose.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
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, 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
Name: Matteo Levisetti, MD
Affiliation: Cue Biopharma
Role: STUDY_CHAIR