A Phase I/II Study of FWD1802 in Patients With ER+/HER2- Advanced BC.
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
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.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Dobrowolny udział w badaniu i podpisanie zgody.
- •Kobieta, w wieku 18 lat lub więcej.
- •Stan zdrowia pozwala na pobranie próbek krwi do badań.
- •Potwierdzony rak piersi, który jest zaawansowany lub rozsiany, reaguje na hormony (ER+) i nie reaguje na HER2 (HER2-).
- •Stan po menopauzie lub zapewnienie braku ciąży.
- •Możliwość i gotowość na przyjmowanie leku FWD1802.
- •Zgoda na terapię zmniejszającą aktywność jajników (jeśli dotyczy).
✗ Disqualifies
- •Rak piersi, który nie spełnia kryteriów ER+ i HER2-.
- •Choroba, która postępuje mimo wcześniejszego leczenia lub jest źle tolerowana.
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Last updated (source)
- February 10, 2026
- Sex
- Female only
Therapies / drugs in trial
Locations (22)
The Second Hospital of Anhui Medical University
Hefei, China
Sun Yat-sen University Cancer Center
Guangzhou, China
Huizhou First Hospital
Huizhou, China
Guangxi Medical University Cancer Hospital
Nanning, China
The First Affiliated Hospital of Henan University of Science & Technology
Luoyang, China
Xinxiang Central Hospital
Xinxiang, China
Henan Cancer Hospital
Zhengzhou, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, China
Hubei Cancer Hospital
Wuhan, China
The Central Hospital of Yongzhou
Yongzhou, China
Jiangsu Province Hospital
Nanjing, China
Jilin Cancer Hospital
Changchun, China
The First Hospital of Jilin University
Changchun, China
First Affiliated Hospital of China Medical University
Shenyang, China
Liaoning Cancer Hospital & Institute
Shenyang, China
Shandong Cancer Hospital
Jinan, China
Fudan University Shanghai Cancer Center
Shanghai, China
Sichuan Cancer Hospital
Chengdu, China
The second people's hospital of Yibin
Yibin, China
Tianjin Medical University Cancer institute & Hospital
Tianjin, China
Sir Run Run Shaw Hospital,affiliated with Zhejiang University School of Medicine
Hangzhou, China
Zhejiang Cancer Hospital
Hangzhou, China
Trial contact
Limin Yin
Contact information from ClinicalTrials.gov. Contact in English.
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/1/2026.