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

NCT ID: NCT07002177

Last Updated: 2026-01-07

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 196 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-01
• Study Completion Date: 2028-11-01

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

Conditions

Metastatic Breast Cancer; Breast Cancer Stage I; Breast Cancer Stage II; Locally Advanced Breast Cancer (LABC); ER+ Breast Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

FWD1802 in combination with Palbociclib (CDK4/6 inhibitor) with or without LHRH agonist；

Group Type: EXPERIMENTAL

Palbociclib 125mg

Intervention Type: DRUG

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

FWD1802

Intervention Type: DRUG

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

FWD1802 in combination with Ribociclib (CDK4/6 inhibitor) with or without LHRH agonist

Group Type: EXPERIMENTAL

Ribociclib 200Mg Oral Tablet

Intervention Type: DRUG

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

FWD1802

Intervention Type: DRUG

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

FWD1802 in combination with Abemaciclib (CDK4/6 inhibitor) with or without LHRH agonist

Group Type: EXPERIMENTAL

Abemaciclib 150 MG

Intervention Type: DRUG

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

FWD1802

Intervention Type: DRUG

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

FWD1802 in combination with Everolimus (mTOR inhibitor) with or without LHRH agonist

Group Type: EXPERIMENTAL

Everolimus 10 mg

Intervention Type: DRUG

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

FWD1802

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

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

Intervention Type: DRUG

Abemaciclib 150 MG

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

Intervention Type: DRUG

Everolimus 10 mg

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

Intervention Type: DRUG

FWD1802

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

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Forward Pharmaceuticals Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Fudan University Shanghai Cancer Center, Shanghai

Shanghai, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Jinglin Xu

Role: CONTACT

xujl@forward-pharm.com

18964533182

Other Identifiers

FWD1802-002C

Identifier Type: -

Identifier Source: org_study_id