A Phase I Clinical Trial of FWD1802 in Patients With ER+/HER2- BC.

PHASE1RecruitingINTERVENTIONAL
Enrollment

99

Participants

Timeline

Start Date

September 12, 2023

Primary Completion Date

November 30, 2025

Study Completion Date

February 28, 2026

Conditions
Metastatic Breast CancerLocally Advanced Breast CancerBreast Cancer Stage IER+ Breast Cancer
Interventions
DRUG

FWD1802

"Subjects will receive FWD1802 tablets orally according to the overall study design; the administration scheme is shown above. Subjects will continue to receive FWD1802 until any of the criteria are met.~Study drugs will be orally administered at the investigational site by site staff at 8 AM on the morning of the dosing days."

DRUG

palbocilib

"The palbociclib dose is the fixed approved dose: 125 mg intake daily, for consecutive 21 days then off for 7 days, which composes 28-day treatment cycle, which is consistent with the 28-day treatment cycle of FWD1802.~Every treatment cycle consists of 28 days."

Trial Locations (1)

200032

RECRUITING

Fudan University Shanghai Cancer Center, Shanghai

All Listed Sponsors
lead

Forward Pharmaceuticals Co., Ltd.

INDUSTRY