Spots Global Cancer Trial Database for BGB-43395 Alone or as Part of Combination Therapies in Participants With Breast Cancer and Other Advanced Solid Tumors
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Trial Identification
Brief Title: BGB-43395 Alone or as Part of Combination Therapies in Participants With Breast Cancer and Other Advanced Solid Tumors
Official Title: A Phase 1a/1b Study Investigating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of the CDK4 Inhibitor BGB-43395, Alone or as Part of Combination Therapies in Patients With Metastatic HR+/HER2- Breast Cancer and Other Advanced Solid Tumors
Study ID: NCT06120283
Conditions
Study Description
Brief Summary: This is a dose escalation and dose expansion study to compare how well BGB-43395, a cyclin-dependent kinase 4 (CDK4) inhibitor, works as monotherapy or in combination with either fulvestrant or letrozole in participants with hormone receptor positive (HR+) and human epidermal growth factor 2 negative (HER2-) breast cancer (BC) and other advanced solid tumors. The main purpose of this study is to explore the recommended dosing for BGB-43395.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Sarah Cannon Research Institute (Scri) At Health One, Denver, Colorado, United States
Duke Cancer Center, Durham, North Carolina, United States
James Cancer Hospital and Solove Research Institute, Columbus, Ohio, United States
The University of Texas Md Anderson Cancer Center, Houston, Texas, United States
Next Oncology, San Antonio, Texas, United States
Blacktown Cancer and Haematology Centre, Blacktown, New South Wales, Australia
Macquarie University, North Ryde, New South Wales, Australia
Austin Health, Heidelberg, Victoria, Australia
Peter Maccallum Cancer Centre, Melbourne, Victoria, Australia
Contact Details
Name: Study Director
Affiliation: BeiGene
Role: STUDY_DIRECTOR
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