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Open-Label Safety and Tolerability Study of INCB057643 in Subjects With Advanced Malignancies

ABSTRACT: The purpose of the Study is to select a dose and assess the safety and tolerability of INCB057643 as a monotherapy (Part 1 and Part 2) and in combination with standard-of-care (SOC) agents (Part 3 and Part 4) for subjects with advanced malignancies. Part 1 will determine the maximum tolerated dose of INCB057643 and/or a tolerated dose that demonstrates sufficient pharmacologic activity. Part 2 will further evaluate the safety, preliminary efficacy, PK, and PD of the dose(s) selected in Part 1 in select tumor types including solid tumors, lymphomas and other hematologic malignancies. Part 3 will determine the tolerated dose of INCB057643 in combination with select SOC agents; and assess the safety and tolerability of the combination therapy in select advanced solid tumors and hematologic malignancies. Part 4 will further evaluate the safety, preliminary efficacy, PK, and PD of the selected dose combination from Part 3 in 4 specific advanced solid tumor and hematologic malignancies.

DISEASE(S): Ovarian Cancer,Solid Tumor,Leukemia,Colorectal Cancer,Non-small Cell Lung Cancer,Prostate Cancer,Pancreatic Cancer,Lymphoma,Breast Cancer,Solid Tumors,Neoplasms,Multiple Myeloma

PROVIDER: 2210462 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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