Last updated on January 2017

Arginase Inhibitor CB-1158 in Patients With Solid Tumors


Brief description of study

This study is an open-label Phase 1 evaluation of CB-1158 as a single agent and in combination with immune checkpoint therapy in patients with advanced/metastatic solid tumors.

Detailed Study Description

This study is an open-label Phase 1 evaluation of CB-1158 as a single agent and in combination with immune checkpoint therapy in patients with advanced/metastatic solid tumors. Single Agent CB-1158: Patients with advanced/metastatic solid tumors be enrolled into escalating monotherapy dose cohorts to determine the Recommended Phase 2 Dose (RP2D) of CB-1158. Additional patients with NSCLC, CRC, and other tumors will be enrolled at the single agent RP2D. Combination Treatment: Patients with advanced/metastatic clear cell renal cell carcinoma, melanoma, and non-small cell lung cancer and other solid tumors previously treated with a PD-1 and PD-L1 therapy will be enrolled into separate cohorts of combination therapy (CB-1158 and nivolumab) to determine the RP2D. Additional patients with NSCLC and melanoma will be enrolled at the combination of CB-1158 with nivolumab at the RP2D. All patients will be assessed for safety, pharmacokinetics, biomarkers and tumor response.

Clinical Study Identifier: NCT02903914

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Frank Tsai, MD

Pinnacle Oncology Hematology
Scottsdale, AZ United States
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Siqing Fu, MD

MD Anderson
Houston, TX United States
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Isabel Jimenez, RN, MSN

START
San Antonio, TX United States
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