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

Launched by FORWARD PHARMACEUTICALS CO., LTD. · May 24, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at the effectiveness and safety of a new treatment called FWD1802 when combined with other therapies for women with a specific type of breast cancer known as ER-positive and HER2-negative. This type of breast cancer can be locally advanced or have spread to other parts of the body. The trial aims to help patients who have already tried standard treatments but their cancer has either continued to grow or they couldn't tolerate those treatments.

To be eligible for this trial, participants need to be women aged between 65 and 74, or younger women who have had their ovaries removed or are in menopause. They must have a confirmed diagnosis of the targeted breast cancer and have experienced issues with previous treatments. Participants will need to provide blood samples for testing and will receive careful monitoring during the study. It's important to note that this trial is not yet recruiting participants, so there will be more information available once it starts.

Gender

FEMALE

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