Spots Global Cancer Trial Database for A Dose-escalation, Expansion Study of ARX788, in Advanced Solid Tumors Subjects With HER2 Expression (ACE-Pan Tumor 01)
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Trial Identification
Brief Title: A Dose-escalation, Expansion Study of ARX788, in Advanced Solid Tumors Subjects With HER2 Expression (ACE-Pan Tumor 01)
Official Title: A Phase 1, Multicenter, Open-label, Multiple Dose-escalation and Expansion Study of ARX788, as Monotherapy in Advanced Solid Tumors With HER2 Expression
Study ID: NCT03255070
Interventions
Study Description
Brief Summary: This 2-part, Phase 1, open-label study will determine the recommended Phase 2 dose (RP2D) of ARX788 in subjects with advanced HER2 positive cancers and will assess the safety and anticancer activity in breast, gastric and other advanced HER2 positive solid tumors.
Detailed Description: Phase 1a will determine the recommended Phase 2 dose (RP2D) in subjects with advanced cancer whose HER2 test results are in situ hybridization (ISH) positive or immunohistochemistry (IHC) 3+, based on safety, tolerability, PK findings and antitumor activity. Phase 1b will assess the safety, tolerability, and PK and anticancer activity in five expansion cohorts, including breast cancer, gastric cancer / gastroesophageal adenocarcinoma, and other advanced HER2-positive solid tumors.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
USC Norris Cancer Hospital, Los Angeles, California, United States
UCLA Hematology-Oncology, Santa Monica, California, United States
Washington University School of Medicine, Saint Louis, Missouri, United States
Cleveland Clinic, Cleveland, Ohio, United States
Baylor Sammons Cancer Center, Dallas, Texas, United States
Research Site, East Albury, New South Wales, Australia
Research Site, North Sydney, New South Wales, Australia
Mater Misericordiae Limited, South Brisbane, Queensland, Australia
Princess Alexandria Hospital, Woolloongabba, Queensland, Australia
Monash Health, Clayton, Victoria, Australia
Research Site, Frankston, Victoria, Australia
Research Site, Nedlands, Western Australia, Australia
Contact Details
Name: Ambrx
Affiliation: Ambrx, Inc.
Role: STUDY_DIRECTOR
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