A Phase Ib/II Study to Evaluate Multiple Combination Therapies of FWD1802 in Patients With ER+/HER2- BC

PHASE1/PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

196

Participants

Timeline

Start Date

June 1, 2025

Primary Completion Date

May 1, 2028

Study Completion Date

November 1, 2028

Conditions
Metastatic Breast CancerBreast Cancer Stage IBreast Cancer Stage IILocally Advanced Breast Cancer (LABC)ER+ Breast Cancer
Interventions
DRUG

FWD1802

orally QD with 28 days each cycle, treatment till disease progression or intolerable toxicity or withdraw for other reasons

DRUG

Palbociclib 125mg

Dose: 125 mg Route: Orally Frequency: Once daily (QD) Schedule: Administered for 21 consecutive days, followed by a 7-day treatment break (3-weeks-on/1-week-off), constituting a 28-day cycle

DRUG

Ribociclib 200Mg Oral Tablet

Dose: 600 mg Route: Orally Frequency: Once daily (QD) Schedule: Administered for 21 consecutive days, followed by a 7-day treatment break, constituting a 28-day cycle

DRUG

Abemaciclib 150 MG

Dose: 150 mg Route: Orally Frequency: BID Schedule: Everyday

DRUG

Everolimus 10 mg

Dose: 10 mg Route: Orally Frequency: QD Schedule: Everyday

All Listed Sponsors
lead

Forward Pharmaceuticals Co., Ltd.

INDUSTRY