Clinical Trial

A Phase I/II Study of FWD1802 in Patients With ER+/HER2- Advanced BC.

Recruiting Phase 1/2
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Record status
This record was last updated February 10, 2026 (before its estimated March 2026 completion). Its status may not reflect the trial's current state.
Summary
A Phase I/II, Open-label study to assess the safety, tolerability, pharmacokinetic, and antitumor efficacy of FWD1802 monotherapy in patients with ER+/HER2- unresectable locally advanced or metastatic breast cancer. This clinical trial aims to explore the role of FWD1802 in the ER+/HER2- advanced breast cancer patient population. The primary objectives are to address the following questions: Phase I Study: Determine the Recommended Phase II Dose (RP2D) and/or Maximum Tolerated Dose (MTD) of FWD1802 in patients with ER-positive, HER2-negative locally advanced or metastatic breast cancer. Phase II Study: To evaluate the efficacy of FWD1802 at the RP2D in patients with ESR1-mutated ER-positive/HER2-negative locally advanced or metastatic breast cancer, using objective response rate (ORR) as the efficacy endpoint.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2023-09-26; most recent amendment 2026-02-06.
Trial Details
NCT Number NCT06064812
Lead Sponsor Forward Pharmaceuticals Co., Ltd.
Conditions Metastatic Breast Cancer, Locally Advanced Breast Cancer, Breast Cancer Stage IV, ER+/HER2- Breast Cancer
Enrollment 99 participants
Start Date 2023-09-12
Primary Completion 2026-03 (estimated)
Study Completion 2028-03 (estimated)
Updated on ClinicalTrials.gov 2026-02-10