RecruitingPhase 1Phase 2NCT07002177

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


Sponsor

Forward Pharmaceuticals Co., Ltd.

Enrollment

196 participants

Start Date

Jun 1, 2025

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This phase Ib/II study is testing FWD1802 — a new targeted therapy — in combination with other drugs for people with estrogen receptor-positive (ER+), HER2-negative breast cancer that has spread or cannot be surgically removed and has progressed after prior hormonal treatments. **You may be eligible if...** - You are postmenopausal or premenopausal (with hormonal suppression) with ER+/HER2- locally advanced or metastatic breast cancer - Your cancer has progressed after at least one line of hormonal therapy - You have had no more than 2 prior chemotherapy regimens for metastatic disease - You have not received prior SERD therapy (except fulvestrant) - You meet additional arm-specific requirements (e.g., prior CDK4/6 inhibitor for certain combinations) **You may NOT be eligible if...** - Your cancer is HER2-positive or hormone receptor-negative - You have not had prior endocrine therapy - You have had more than 2 prior chemotherapy lines for metastatic disease - You have serious uncontrolled health conditions - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGFWD1802

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

DRUGPalbociclib 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

DRUGRibociclib 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

DRUGAbemaciclib 150 MG

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

DRUGEverolimus 10 mg

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


Locations(1)

Fudan University Shanghai Cancer Center, Shanghai

Shanghai, China

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NCT07002177


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