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Clinical Trials in China / NCT07002177
Recruiting Phase 1/2

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

NCT07002177 · tracked via the Priya Life Science China tracker
Sponsor
Forward Pharmaceuticals Co., Ltd.
Phase
Phase 1/2
Started
2025-06-01
Last updated
2026-01-07

Condition(s) studied

Metastatic Breast CancerBreast Cancer Stage IBreast Cancer Stage IILocally Advanced Breast Cancer (LABC)ER+ Breast Cancer

Investigational drug(s) / intervention(s)

FWD1802Palbociclib 125mgRibociclib 200Mg Oral TabletAbemaciclib 150 MGEverolimus 10 mg

FWD1802: orally QD with 28 days each cycle, treatment till disease progression or intolerable toxicity or withdraw for other reasons

Palbociclib 125mg: Dose: 125 mg Route: Orally Frequency: Once daily (QD) Schedule: Administered for 21 consecutive days, followed by a 7-day treatment break (3-weeks-on/1-week-off), constituting a 28-day cycle

Ribociclib 200Mg Oral Tablet: Dose: 600 mg Route: Orally Frequency: Once daily (QD) Schedule: Administered for 21 consecutive days, followed by a 7-day treatment break, constituting a 28-day cycle

Abemaciclib 150 MG: Dose: 150 mg Route: Orally Frequency: BID Schedule: Everyday

Everolimus 10 mg: Dose: 10 mg Route: Orally Frequency: QD Schedule: Everyday

Study 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

Sex
FEMALE
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Fudan University Shanghai Cancer Center, Shanghai Shanghai China Recruiting

More Forward Pharmaceuticals Co., Ltd. trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07002177 on ClinicalTrials.gov ↗ ← All trials in China