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CUE-102 (1 mg/kg) Monotherapy IV infusion every 3 weeks for up to 2 years

CUE-102 (2 mg/kg) Monotherapy IV infusion every 3 weeks for up to 2 years

CUE-102 (4 mg/kg) Monotherapy IV infusion every 3 weeks for up to 2 years

CUE-102 (8 mg/kg) Monotherapy IV infusion every 3 weeks for up to 2 years

Dose expansion of CUE-102 at determined RP2D Monotherapy IV infusion every 3 weeks for up to 2 years

CUE-102 is a novel fusion protein developed for the treatment of patients with WT1-positive malignancies.

CUE-102

Steven Margossian, M.D., Ph.D.

Reena Lynam

Bekaii Saab

Katherine Eckert

Lauren Ponto

Katie Coleman

Lei Zheng, M.D, PhD

Preston Buechler

Zhaohui Jin

Amanda Hall

Christopher Chen

Gunnar Lauer

Ashley Wallace

John Powderly, M.D.

Carrie Smith

Nashat Gabrail, M.D.

UH SCC Cancer Information Services

Jing Peng

Sue Quinsey

Cancer Connect

Matteo Levisetti, MD

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.

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.

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

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

Evaluate dose-limiting toxicities (DLTs) during the first cycle of treatment with CUE-102, and to establish a recommended Phase 2 dose (RP2D)

Evaluate maximum tolerated dose (MTD) to establish a recommended Phase 2 dose (RP2D)

Area under the concentration-time curve (AUC) of CUE-102.

Maximum serum concentration (Cmax) of CUE-102.

To evaluate safety and tolerability of CUE-102 using NCI CTCAE v5.0.

To evaluate antitumor response rate of CUE-102 by RECIST 1.1

To evaluate antitumor duration of response of CUE-102 by RECIST 1.1

To evaluate antitumor clinical benefit rate of CUE-102 by RECIST 1.1

To evaluate antitumor progression-free survival of CUE-102 by RECIST 1.1

To evaluate overall survival after treatment with CUE-102

To evaluate the potential for immune response after treatment with CUE-102 using assessment of number of WT1 tetramer-positive T cell lymphocytes.

To evaluate the potential for immune response after treatment with CUE-102 using assessment of cytotoxic T lymphocyte (CTL) markers of activation

**Spots Global Cancer Trial Database for hla a*0201**

Every month we try and update this database with for hla a*0201 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for hla a*0201

Every month we try and update this database with for hla a*0201 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

**Spots Global Cancer Trial Database for hla a*0201**

Every month we try and update this database with for hla a*0201 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.