NCT04509596 - DZD1516 in Combination With Trastuzumab and Capecitabine, or in Combination With T-DM1, in Patients With Metastatic HER2 Positive Breast Cancer | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

September 21, 2020

Primary Completion Date

July 7, 2022

Study Completion Date

July 7, 2022

Conditions

Breast Cancer Metastatic

Interventions

DRUG

DZD1516 mono therapy in Part A, DZD1516 in combination with trastuzumab and/or capecitabine in Part B, DZD1516 in combination with T-DM1 in Part C

"Part A is twice daily (except Cycle 0) oral dosing of DZD1516, starting from 50 mg. If tolerated, dose will be escalated in subsequent cohorts until MTD.~Part B is twice daily oral dosing of DZD1516 in combination with capecitabine 1000 mg/m2 orally twice daily on Days 1-14 of each 21-day cycle or with trastuzumab 8 mg/kg intravenously (IV) on Day 1 of Cycle 1, followed by 6 mg/kg on Day 1 of each 21-day cycle.~Part C is twice daily oral dosing of DZD1516 in combination with T-DM1 3.6 mg/kg intravenously (IV) once every 21 days"

Trial Locations (3)

90404

UCLA Hematology/Oncology Parkside, Santa Monica

Unknown

Zhejiang Cancer Hospital, Hangzhou

Cancer Hospital, Fudan University, Shanghai