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

Active:	Yes
Cancer Type:	Colon/Rectal Cancer Ovarian Cancer Pancreatic Cancer Stomach/ Gastric Cancer	NCT ID:	NCT05360680
Trial Phases:	Phase I	Protocol IDs:	CUE-102-01 (primary) NCI-2022-05169
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	Cue BioPharma
NCI Full Details:	http://clinicaltrials.gov/show/NCT05360680

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.

Objectives

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.

Treatment Sites in Georgia

Winship Cancer Institute of Emory University
1365 Clifton Road NE
Building C
Atlanta, GA 30322
404-778-5180
winshipcancer.emory.edu

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.