Spots Global Cancer Trial Database for Study of A166 in Patients With Relapsed/Refractory Cancers Expressing HER2 Antigen or Having Amplified HER2 Gene
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Trial Identification
Brief Title: Study of A166 in Patients With Relapsed/Refractory Cancers Expressing HER2 Antigen or Having Amplified HER2 Gene
Official Title: A Phase I-II, FIH Study of A166 in Locally Advanced/Metastatic Solid Tumors Expressing Human Epidermal Growth Factor Receptor 2 (HER2) or Are HER2 Amplified That Did Not Respond or Stopped Responding to Approved Therapies
Study ID: NCT03602079
Conditions
Interventions
Study Description
Brief Summary: Open-label, Phase I-II, first-in-human (FIH) study for A166 monotherapy in HER2-expressing or amplified patients who progressed on or did not respond to available standard therapies. Patients must have documented HER2 expression or amplification. The patient must have exhausted available standard therapies. Patients will receive study drug as a single IV infusion. Cycles will continue until disease progression or unacceptable toxicity.
Detailed Description: This is an open-label, Phase I-II, first-in-human (FIH) study for A166 as monotherapy in HER2-expressing patients who progressed on or did not respond to available standard therapies. Patients enrolled in this Phase III study must have documented HER2 positivity defined as positive on in situ hybridization (ISH) or next-generation sequencing (NGS) or HER2 expression, defined as at least 1+ by validated immunohistochemistry (IHC) test. The patient must be, in the judgment of the investigator, an appropriate candidate for experimental therapy after available standard therapies have ceased to provide clinical benefit for their disease. Patients will receive study drug as a single IV infusion at the prescribed dose level in each treatment cycle. Cycles will continue until disease progression or unacceptable toxicity. The study is divided into 2 parts (Phase I and Phase II).
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Florida Cancer Specialists & Research Institute, Sarasota, Florida, United States
Beth Israel Deaconess Medical Center Cancer Center, Boston, Massachusetts, United States
Karmanos Cancer Institute, Detroit, Michigan, United States
Clinical Research Alliance, Inc., Lake Success, New York, United States
Stephenson Cancer Center, Oklahoma City, Oklahoma, United States
Providence Cancer Institute, Portland, Oregon, United States
Mary Crowley Cancer Research Centers - Medical City, Dallas, Texas, United States
The University of Texas MD Anderson Cancer Center, Houston, Texas, United States
South Texas Accelerated Research Therapeutics, LLC (START), San Antonio, Texas, United States
Virginia Cancer Specialist, Fairfax, Virginia, United States
Contact Details
Name: Jordi Rodon Ahnert, MD, PhD
Affiliation: MD Anderson
Role: STUDY_CHAIR
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