NCT07002177

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

An Open-label, Multicenter, Phase Ib/II Clinical Study to Evaluate the Safety and Efficacy of Multiple Combination Therapies With FWD1802 in Subjects With ER-positive/HER2-negative Unresectable Locally Advanced or Metastatic Breast Cancer

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 196 (estimated)
• Sponsor: Forward Pharmaceuticals Co., Ltd. · Industry
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a Study to Evaluate the Efficacy and Safety of Multiple Combination Therapies with FWD1802 in Subjects with ER-positive/HER2-negative Unresectable Locally Advanced or Metastatic Breast Cancer

Conditions

• Metastatic Breast Cancer
• Breast Cancer Stage I
• Breast Cancer Stage II
• Locally Advanced Breast Cancer (LABC)
• ER+ Breast Cancer

Interventions

Type	Name	Description
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

Timeline

• Start date: 2025-06-01
• Primary completion: 2028-05-01
• Completion: 2028-11-01
• First posted: 2025-06-03
• Last updated: 2026-01-07

Locations

1 site across 1 country: China