NCT07002177 A Phase Ib/II Study to Evaluate Multiple Combination Therapies of FWD1802 in Patients With ER+/HER2- BC
| NCT ID | NCT07002177 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Forward Pharmaceuticals Co., Ltd. |
| Condition | Metastatic Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 196 participants |
| Start Date | 2025-06-01 |
| Primary Completion | 2028-05-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 196 participants in total. It began in 2025-06-01 with a primary completion date of 2028-05-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This is a Study to Evaluate the Efficacy and Safety of Multiple Combination Therapies with FWD1802 in Subjects with ER-positive/HER2-negative Unresectable Locally Advanced or Metastatic Breast Cancer
Eligibility Criteria
Inclusion Criteria: * 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 meet at least one of the following criteria: postmenopausal or prior bilateral oophorectomy, or postmenopausal or Premenopausal/perimenopausal women must agree to receive and maintain approved luteinizing hormone-releasing hormone (LHRH) agonist therapy during study treatment * Prior Therapy Requirements:Subjects must meet all of the following criteria: 1. Progression during/after, intolerance to, ineligibility for, or refusal of standard therapy 2. Endocrine therapy history: Recurrence during or within 1 year after completing ≥2 years of adjuvant endocrine therapy;OR progression after ≥1 line of endocrine therapy for advanced breast cancer(ABC) with ≥6 months of maintenance therapy (no restriction on the number of prior endocrine therapy lines). 3. ≤2 prior lines of chemotherapy for ABC 4. No prior SERD (selective estrogen receptor degrader) therapy except fulvestrant 5. Everolimus combination arm: Prior CDK4/6 inhibitor therapy requiredf) CDK4/6 inhibitor combination arm:Permitted ≤1 line of prior non-investigational CDK4/6 inhibitor therapy;If only received adjuvant CDK4/6 inhibitor therapy, recurrence must occur \>12 months after treatment completion Note: Antibody-drug conjugates (ADCs) are classified as chemotherapy in this study. * Phase Ib: At least one evaluable lesion per RECIST v1.1, allowed subjects with osteolytic bone lesion(s) confirmed by CT/MRI.Phase II: At least one measurable lesion per RECIST v1.1. Subject must have sufficient organ and bone marrow functions at screening. Exclusion Criteria: * Leptomeningeal metastasis (carcinomatous meningitis)；Spinal cord compression；Symptomatic or clinically unstable central nervous system (CNS) metastases； * History or any persistent chronic gastrointestinal disorders or other conditions of impaired absorption that may interfere with oral absorption of the investigational drug * Symptomatic visceral metastases , or clinically symptomatic and unstable effusions;Pleural effusion;Ascites;Pericardial effusion or Pulmonary lymphangitis carcinomatosa. Prior intracavitary infusion therapy should have more than 14 days of stabilization, * Prior therapy with any selective estrogen receptor degrader (SERD) or similar agents other than fulvestrant * Inadequate washout period for prior anticancer therapies. * Type 1 diabetes mellitus; Type 2 diabetes mellitus with poor glycemic control at screening(applies only to the everolimus combination arm). * Subjects will be excluded if they meet any of the following: 1. Interstitial lung disease or drug-induced ILD history, OR evidence of active pneumonitis on chest CT scan within 4 weeks prior to first study treatment. 2. Severe pulmonary disease at screening, including but not limited to:Severe asthma;Severe chronic obstructive pulmonary disease (COPD) Idiopathic * Uncontrolled hypertension despite antihypertensive therapy, defined as:Systolic blood pressure (SBP) \>150 mmHg OR Diastolic blood pressure (DBP) \>95 mmHg. * Active cardiac disease or history of cardiac dysfunction
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07002177 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 75 Years, studying Metastatic Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07002177 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07002177 currently recruiting?
Yes, NCT07002177 is actively recruiting participants. Contact the research team at xujl@forward-pharm.com for enrollment information.
Where is the NCT07002177 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT07002177 clinical trial?
NCT07002177 is sponsored by Forward Pharmaceuticals Co., Ltd.. The trial plans to enroll 196 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.