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Study identifier: NCT06064812 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

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

Condition: Metastatic Breast Cancer · Locally Advanced Breast Cancer · Breast Cancer Stage IV  ·  Sponsor: Forward Pharmaceuticals Co., Ltd.

PhasePhase 1/Phase 2
Planned participants99
Who can joinFemale, 18 Years to no upper limit
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Limin Yin  ·  18520159114  ·  yinlm@forward-pharm.com

Always discuss trial participation with your own doctor first.

Locations (22)

The Second Hospital of Anhui Medical UniversityHefei, Anhui, ChinaRecruiting
Sun Yat-sen University Cancer CenterGuangzhou, Guangdong, ChinaRecruiting
Huizhou First HospitalHuizhou, Guangdong, ChinaRecruiting
Guangxi Medical University Cancer HospitalNanning, Guangxi, ChinaRecruiting
The First Affiliated Hospital of Henan University of Science & TechnologyLuoyang, Henan, ChinaRecruiting
Xinxiang Central HospitalXinxiang, Henan, ChinaRecruiting
Henan Cancer HospitalZhengzhou, Henan, ChinaRecruiting
The First Affiliated Hospital of Zhengzhou UniversityZhengzhou, Henan, ChinaNot Yet Recruiting
Hubei Cancer HospitalWuhan, Hubei, ChinaNot Yet Recruiting
The Central Hospital of YongzhouYongzhou, Hunan, ChinaRecruiting
Jiangsu Province HospitalNanjing, Jiangsu, ChinaRecruiting
Jilin Cancer HospitalChangchun, Jilin, ChinaRecruiting

+ 10 more locations — full list on the registry record.

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Source record: clinicaltrials.gov/study/NCT06064812