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Spots Global Cancer Trial Database for A Phase 1 in Patients With HLA-A*0201+ and WT1+ Recurrent/Metastatic Cancers

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Trial Identification

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

Interventions

CUE-102

Study Description

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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Name: Matteo Levisetti, MD

Affiliation: Cue Biopharma

Role: STUDY_CHAIR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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