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An Open-Label, Dose Escalation, Phase 1, First-in-Human Study of TAK-164, an Antibody-Drug Conjugate, in Patients with Advanced Gastrointestinal Cancers Expressing Guanylyl Cyclase C
The purpose of this study is to: Test the safety of the research study drug, TAK-164 and to find out the highest, safest dose that can be given to study participants. Obtain information on the amount of TAK-164 in the blood after taking doses of the study drug. Understand how well the participant's cancer and their body respond to TAK-164.
The Primary Objective is: To evaluate the safety of TAK-164 and to determine the MTD and recommended phase 2 dose and schedule. The Secondary Objectives are: To characterize the PK of TAK-164. To evaluate immunogenicity of TAK-164. To evaluate efficacy of TAK-164 as measured by overall response rate (ORR). To evaluate other efficacy measures such as DCR, which includes response (Complete response [CR]+partial response [PR]) plus stable disease, DOR, and PFS. The Exploratory Objectives are: To characterize the molecular profile of patients (including gene expression, IHC, cell-free DNA and others) and to assess relationships with clinical response. To evaluate the pharmacodynamic effect of TAK-164 in tumor and/or liquid biopsies as part of the expansion phase (Part B).