A Phase Ib Study of HS-10352 Plus Fulvestrant in Patients With Advanced Breast Cancer

PHASE1RecruitingINTERVENTIONAL
Enrollment

224

Participants

Timeline

Start Date

January 12, 2022

Primary Completion Date

July 31, 2023

Study Completion Date

December 31, 2025

Conditions
Breast Cancer
Interventions
DRUG

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)."

DRUG

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)."

Trial Locations (1)

200032

RECRUITING

Fudan University Shanghai Cancer Center, Shanghai

All Listed Sponsors
lead

Jiangsu Hansoh Pharmaceutical Co., Ltd.

INDUSTRY