Spots Global Cancer Trial Database for A Study of TAK-186 (Also Known as MVC-101) in Adults With Advanced or Metastatic Cancer
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Trial Identification
Brief Title: A Study of TAK-186 (Also Known as MVC-101) in Adults With Advanced or Metastatic Cancer
Official Title: A Phase 1/2, First-in-Human, Open-Label, Dose-Escalation Study of TAK-186 (Also Known as MVC-101), An EGFR x CD3 COnditional Bispecific Redirected Activation (COBRA) Protein in Patients With Unresectable Locally Advanced or Metastatic Cancer
Study ID: NCT04844073
Interventions
Study Description
Brief Summary: The main aim of this study is to check for side effects and tolerability of TAK-186 (also known as MVC-101) in adults with unremovable advanced or metastatic cancer. Another aim is to characterize and evaluate the activity of TAK-186 (MVC-101). Participants may receive treatment throughout the study for a maximum of 13 months and will be followed up at 30 days and 90 days and then every 12 weeks for up to 48 weeks after the last treatment.
Detailed Description: This Phase 1/2, open-label study will characterize safety and dose-limiting toxicities (DLTs) of TAK-186. Dose escalation will occur in participants with advanced solid tumors. A Cohort Expansion Phase will be enrolled to further characterize safety and initial anti-tumor activity in participants with solid tumors expressing epidermal growth factor receptor (EGFR), including HNSCC, CRC or NSCLC.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of California San Francisco, San Francisco, California, United States
University of Colorado Anshutz Medical Campus, Aurora, Colorado, United States
University of Yale, New Haven, Connecticut, United States
Georgetown, Washington, District of Columbia, United States
Indiana University, Indianapolis, Indiana, United States
University of Minnesota, Minneapolis, Minnesota, United States
Sanford University, Sioux Falls, South Dakota, United States
Avera Cancer Institute, Sioux Falls, South Dakota, United States
Mary Crowley Cancer Research, Dallas, Texas, United States
MD Anderson, Houston, Texas, United States
Chris O'Brien Lifehouse, Camperdown, New South Wales, Australia
Scientia Clinical Research Limited, Corner High & Avoca Street, 5th Floor, Bright Building, Randwick, New South Wales, Australia
Southern Oncology Clinical Research Unit, 1 Flinders Drive, Bedford Park, South Australia, Australia
Monash Health, Monash Medical Center, 246 Clayton Road, Clayton, Victoria, Australia
The Alfred Hospital, Melbourne, Victoria, Australia
Austin Hospital, 145 Studley Road, Intensive Care Unit, Heidelberg, , Australia
Seoul National University Hospital, Seoul, , Korea, Republic of
Samsung, Seoul, , Korea, Republic of
Contact Details
Name: Study Director
Affiliation: Takeda
Role: STUDY_DIRECTOR
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