224
Participants
Start Date
January 12, 2022
Primary Completion Date
July 31, 2023
Study Completion Date
December 31, 2025
HS-10352 combined with fulvestrant (Stage 1)
"Drug: HS-10352 HS-10352 will be administered at escalating doses orally once daily on a continuous dosing schedule starting on Cycle 1 Day 1 (C1D1) in a 28 day cycle.~Drug: Fulvestrant Fulvestrant is administered at a dose of 500 mg intramuscular on Cycle 1 Day 1, Day 15, and Day 1 of every cycle thereafter (where a cycle is 28 days)."
HS-10352 combined with fulvestrant (Stage 2)
"Drug: HS-10352 participants will be enrolled into Cohort 2 (endocrine therapy-resistant) and Cohort 3 (endocrine therapy-sensitive or naïve) respectively and HS-10352 will be administered at the recommended dose identified in Part 1.~Drug: Fulvestrant Fulvestrant is administered at a dose of 500 mg intramuscular on Cycle 1 Day 1, Day 15, and Day 1 of every cycle thereafter (where a cycle is 28 days)."
RECRUITING
Fudan University Shanghai Cancer Center, Shanghai
Lead Sponsor
Jiangsu Hansoh Pharmaceutical Co., Ltd.
INDUSTRY