Solid Tumors (CUE-102)

Solid Tumors (CUE-102)

Cue Biopharma is evaluating the safety and anti-tumor activity of CUE-102 as a monotherapy in a Phase 1 open-label, 2-part, multicenter clinical study for the potential treatment of people with Wilms’ Tumor 1 (WT1)-positive recurrent/metastatic solid tumors who have failed conventional therapies.

The trial consists of two parts. 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 recommended Phase 2 dose identified in Part A, and to evaluate antitumor activity at this dose.

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About Wilms’ Tumor 1 (WT1)-positive cancers

Wilms’ Tumor 1 protein (WT1) is a well-recognized oncofetal protein that is known to be over-expressed in numerous cancers, including solid tumors and hematologic malignancies, such as acute myeloid leukemia (AML) and ovarian, gastric, endometrial, breast, lung, colorectal and pancreatic cancers. WT1 has been ranked first amongst 75 tumor associated antigens in an effort by the National Cancer Institute to prioritize cancer antigens for therapeutic targeting1.  

Development of novel modalities to target WT1 provide a significant opportunity to address high unmet medical need in WT1-positive malignancies.


1. Cheever MA, Allison JP, Ferris AS, et al. The Prioritization of Cancer Antigens: A National Cancer Institute Pilot Project for the Acceleration of Translational Research. Clin Cancer Res 15(17): 5323–5337, 2009 (doi: 10.1158/1078-0432.CCR-09-0737)