Actively Recruiting
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
Led by Forward Pharmaceuticals Co., Ltd. · Updated on 2026-01-07
196
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of multiple combination therapies with the drug FWD1802 in women who have ER-positive/HER2-negative breast cancer that cannot be removed by surgery and is either locally advanced or has spread to other parts of the body. This phase Ib/II clinical study is sponsored by Forward Pharmaceuticals Co., Ltd. and aims to understand how these combinations work in this specific breast cancer type. The study involves giving participants FWD1802 orally once daily in 28-day treatment cycles until the disease progresses, side effects become intolerable, or they choose to stop. Participants receive one of several combination treatments: FWD1802 with Palbociclib, Ribociclib, Abemaciclib, or Everolimus, each given with or without a hormone therapy called luteinizing hormone-releasing hormone (LHRH) agonist. Each combination follows a specific dosing schedule, such as Palbociclib and Ribociclib being given daily for 21 days followed by a 7-day break, while Abemaciclib and Everolimus are taken every day. During the study, participants will be closely monitored for side effects, vital signs, and heart function using ECGs. Researchers will assess how well the cancer responds to treatment using standard criteria and study the drug’s behavior in the body through blood tests. The study will last approximately 1.5 to 2 years, during which safety events, tumor responses, and other health measures will be tracked to evaluate the treatments' impact.
CONDITIONS
Brief Title
A Phase Ib/II Study to Evaluate Multiple Combination Therapies of FWD1802 in Patients With ER+/HER2- BC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subjects consent to provide blood samples for centralized laboratory testing of ESR1 mutation status and other biomarkers
- Histologically or cytologically confirmed ER-positive/HER2-negative locally advanced or metastatic breast cancer
- Subjects must be postmenopausal, have had prior bilateral oophorectomy, or agree to receive and maintain approved luteinizing hormone-releasing hormone (LHRH) agonist therapy during study treatment if premenopausal or perimenopausal
- Progression during/after, intolerance to, ineligibility for, or refusal of standard therapy
- Recurrence during or within 1 year after completing 2 or more years of adjuvant endocrine therapy, or progression after 1 or more lines of endocrine therapy for advanced breast cancer with 6 months or more of maintenance therapy
- 2 or fewer prior lines of chemotherapy for advanced breast cancer
- No prior selective estrogen receptor degrader (SERD) therapy except fulvestrant
- Prior CDK4/6 inhibitor therapy required for Everolimus combination arm
- One or fewer lines of prior non-investigational CDK4/6 inhibitor therapy permitted for CDK4/6 inhibitor combination arms with specific timing conditions
- Phase Ib: At least one evaluable lesion per RECIST v1.1; Phase II: At least one measurable lesion per RECIST v1.1
- Sufficient organ and bone marrow functions at screening
You will not qualify if you...
- Leptomeningeal metastasis, spinal cord compression, symptomatic or clinically unstable central nervous system metastases
- History or persistent chronic gastrointestinal disorders or other conditions impairing oral drug absorption
- Symptomatic visceral metastases or clinically unstable effusions including pleural effusion, ascites, pericardial effusion, or pulmonary lymphangitis carcinomatosa
- Prior therapy with any selective estrogen receptor degrader (SERD) other than fulvestrant
- Inadequate washout period for prior anticancer therapies
- Type 1 diabetes or poorly controlled type 2 diabetes at screening (for Everolimus arm)
- Interstitial lung disease or active pneumonitis on chest CT within 4 weeks prior to treatment
- Severe pulmonary diseases such as severe asthma or severe chronic obstructive pulmonary disease
- Uncontrolled hypertension despite medication (SBP >150 mmHg or DBP >95 mmHg)
- Active cardiac disease or history of cardiac dysfunction
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated 28-day cycles until disease progression or discontinuation
Participants receive oral treatment with FWD1802 combined with one of several drugs including Palbociclib, Ribociclib, Abemaciclib, or Everolimus. Treatment cycles last 28 days and continue until disease progression, intolerable toxicity, or withdrawal for other reasons.
Visits occur regularly each cycle to monitor safety and response
Trial Site Locations
Total: 1 location
1
Fudan University Shanghai Cancer Center, Shanghai
Shanghai, China
Actively Recruiting
Research Team
J
Jinglin Xu
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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