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

Sponsor
Forward Pharmaceuticals Co., Ltd.
Study ID
NCT07002177
Phase
PHASE1/PHASE2
Status
Recruiting
Apply to this trial

Conditions

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

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • FWD1802 — DRUG
    orally QD with 28 days each cycle, treatment till disease progression or intolerable toxicity or withdraw for other reasons
  • Palbociclib 125mg — DRUG
    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
  • Ribociclib 200Mg Oral Tablet — DRUG
    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
  • Abemaciclib 150 MG — DRUG
    Dose: 150 mg Route: Orally Frequency: BID Schedule: Everyday
  • Everolimus 10 mg — DRUG
    Dose: 10 mg Route: Orally Frequency: QD Schedule: Everyday

Study Details

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

Key Dates

Start date
Jun 1, 2025
Status verified
Jan 2026
Primary completion
May 1, 2028
Completion
Nov 1, 2028

Study Design

Enrollment
196 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: FWD1802 in combination with Palbociclib (CDK4/6 inhibitor) with or without LHRH agonist；
  • Experimental: FWD1802 in combination with Ribociclib (CDK4/6 inhibitor) with or without LHRH agonist
  • Experimental: FWD1802 in combination with Abemaciclib (CDK4/6 inhibitor) with or without LHRH agonist
  • Experimental: FWD1802 in combination with Everolimus (mTOR inhibitor) with or without LHRH agonist

Primary Outcome Measure

Phase Ib- Dose-Limiting Toxicity (DLT). [ Time Frame: Approximately 1.5 years ]

Central Contacts

Related Studies