Actively Recruiting
A Phase I/II, Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Anti-tumor Efficacy of FWD1802 in Patients With ER+/HER2- Unresectable Locally Advanced or Metastatic Breast Cancer
Led by Forward Pharmaceuticals Co., Ltd. · Updated on 2026-02-10
99
Participants Needed
22
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating FWD1802, a drug being studied for patients with estrogen receptor-positive (ER+), human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer that cannot be removed by surgery or has spread to other parts of the body. This phase I/II study aims to find the best dose of FWD1802 and assess its safety, tolerability, and effect on tumors, especially in patients whose cancer has specific ESR1 mutations. The study is multicenter, open-label, and includes patients with locally advanced or metastatic breast cancer. The study has three parts: Phase I Part A is a dose-escalation phase where up to 27 patients receive increasing doses of FWD1802 tablets, starting with a single dose followed by daily dosing in 28-day cycles. Phase I Part B is a dose-expansion phase exploring 2 to 4 selected dose levels in up to 10 patients per dose to study pharmacokinetics and confirm the recommended dose for Phase II. Phase II focuses on up to 60 patients with ESR1 mutations receiving one or two dose levels to evaluate FWD1802's anti-tumor efficacy and safety. Treatment may continue up to two years or longer if beneficial and agreed upon. Participants will undergo screening including mutation testing and must meet health criteria to join. During treatment, they will receive FWD1802 daily and have blood tests to monitor mutations and drug effects. The study measures safety, drug levels in the body, tumor response, and patient outcomes over about two years. Follow-up includes monitoring for side effects, response to treatment, and disease progression. The trial is designed to gather detailed information about FWD1802's use in this breast cancer type and mutation status.
CONDITIONS
Brief Title
A Phase I/II Study of FWD1802 in Patients With ER+/HER2- Advanced BC.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female aged 18 years or older
- Willing to voluntarily participate and sign informed consent
- Diagnosis of locally advanced or metastatic breast cancer that is ER-positive and HER2-negative
- Able to provide blood samples for ESR1 mutation and biomarker testing
- Confirmed menopausal status or willing to use ovarian function suppression if premenopausal
- Prior disease progression or intolerance to standard therapy, with specific previous treatments as detailed
- ECOG performance status of 0 or 1
- At least one measurable lesion per RECIST 1.1
- Expected survival of at least 3 months
- Adequate organ and bone marrow function as defined by laboratory tests
- Negative pregnancy test if of childbearing potential and agreement to use effective contraception
You will not qualify if you...
- Presence of leptomeningeal metastases, symptomatic or unstable CNS metastases
- Ongoing gastrointestinal diseases affecting drug absorption or inability to swallow oral medication
- Symptomatic visceral metastases or unstable effusions without stabilization
- Recent use of investigational drugs, chemotherapy, radiotherapy, or certain medications within specific washout periods
- Unresolved toxicities from prior anti-tumor treatments above specified grades
- Major surgery within 4 weeks prior to first dose or incomplete healing
- Active malignancies within past 5 years except specified exceptions
- History or evidence of interstitial lung disease or active pneumonitis
- Poorly controlled hypertension
- Active hepatitis B or C, HIV, active tuberculosis or syphilis
- Recent severe infections needing antibiotics
- Recent arterial or venous thrombotic events within 6 months
- Significant cardiac disease or dysfunction as detailed
- History of severe allergic reactions to study drug components
- Prior use of certain selective estrogen receptor degraders or investigational ER inhibitors
- Active or significant corneal or eye diseases
- History of drug, alcohol, or substance abuse
- Recent use of live vaccines or immunomodulatory drugs
- History of organ or stem cell transplantation
- Any condition deemed unsuitable by the investigator including neurological disorders or poor compliance
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - Up to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Duration - 7 days
Participants receive a single dose of FWD1802 followed by a 6-day dosing pause as part of the single-agent lead-in period.
1 visit for dosing and observation
Duration - Up to 2 years
Participants receive daily oral doses of FWD1802 in 28-day cycles. Treatment continues for up to 2 years or until disease progression, unacceptable toxicity, withdrawal, or other discontinuation reasons occur. Participants in Phase II may undergo additional ctDNA testing during treatment.
Daily dosing with 28-day treatment cycles; additional visits for ctDNA testing on Cycle 1 Day 15, Cycle 2 Day 1, after disease progression, and as needed
Duration - Duration not specified
Participants are followed after treatment ends to monitor safety and outcomes.
Visit schedule varies after treatment completion
Trial Site Locations
Total: 22 locations
1
The Second Hospital of Anhui Medical University
Hefei, Anhui, China
Actively Recruiting
2
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Actively Recruiting
3
Huizhou First Hospital
Huizhou, Guangdong, China
Actively Recruiting
4
Guangxi Medical University Cancer Hospital
Nanning, Guangxi, China
Actively Recruiting
5
The First Affiliated Hospital of Henan University of Science & Technology
Luoyang, Henan, China
Actively Recruiting
6
Xinxiang Central Hospital
Xinxiang, Henan, China
Actively Recruiting
7
Henan Cancer Hospital
Zhengzhou, Henan, China
Actively Recruiting
8
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Not Yet Recruiting
9
Hubei Cancer Hospital
Wuhan, Hubei, China
Not Yet Recruiting
10
The Central Hospital of Yongzhou
Yongzhou, Hunan, China
Actively Recruiting
11
Jiangsu Province Hospital
Nanjing, Jiangsu, China
Actively Recruiting
12
Jilin Cancer Hospital
Changchun, Jilin, China
Actively Recruiting
13
The First Hospital of Jilin University
Changchun, Jilin, China
Actively Recruiting
14
First Affiliated Hospital of China Medical University
Shenyang, Liaoning, China
Actively Recruiting
15
Liaoning Cancer Hospital & Institute
Shenyang, Liaoning, China
Actively Recruiting
16
Shandong Cancer Hospital
Jinan, Shandong, China
Actively Recruiting
17
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
18
Sichuan Cancer Hospital
Chengdu, Sichuan, China
Actively Recruiting
19
The second people's hospital of Yibin
Yibin, Sichuan, China
Actively Recruiting
20
Tianjin Medical University Cancer institute & Hospital
Tianjin, Tianjin Municipality, China
Actively Recruiting
21
Sir Run Run Shaw Hospital,affiliated with Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Actively Recruiting
22
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
Actively Recruiting
Research Team
L
Limin Yin
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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