A Phase Ib/II Study to Evaluate Multiple Combination Therapies of FWD1802 in Patients With ER+/HER2- BC

Recruiting now · Phase 1/Phase 2

Conditions studied: Metastatic Breast Cancer, Breast Cancer Stage I, Breast Cancer Stage II, Locally Advanced Breast Cancer (LABC), ER+ Breast Cancer

In brief

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

Key facts

Study ID: NCT07002177
Run by: Forward Pharmaceuticals Co., Ltd.
People needed: 196
Starts: 2025-06-01
Expected to finish: 2028-11-01
Last updated by the study team: 2026-01-07

Who can join

Age: 18 and older, up to 75. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

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:
Progression during/after, intolerance to, ineligibility for, or refusal of standard therapy
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).
≤2 prior lines of chemotherapy for ABC
No prior SERD (selective estrogen receptor degrader) therapy except fulvestrant
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.

You may not qualify if…

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:
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.
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

Where it is running

Fudan University Shanghai Cancer Center, Shanghai — Shanghai, China (enrolling)

Full record on ClinicalTrials.gov

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