Menu
Recruiting NCT07002177

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

Phase I / Phase II Interventional Metastatic Breast Cancer Breast Cancer Stage I Breast Cancer Stage II Locally Advanced Breast Cancer (LABC)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: FWD1802, Palbociclib 125mg, Ribociclib 200Mg Oral Tablet, Abemaciclib 150 MG.
Who it may be relevant to
Registry conditions: Metastatic Breast Cancer, Breast Cancer Stage I, Breast Cancer Stage II, Locally Advanced Breast Cancer (LABC). Basic parameters: 18 years — 75 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

An Open-label, Multicenter, Phase Ib/II Clinical Study to Evaluate the Safety and Efficacy of Multiple Combination Therapies With FWD1802 in Subjects With ER-positive/HER2-negative Unresectable Locally Advanced or Metastatic Breast Cancer

Overview

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

Interventions

  • Drug FWD1802
    orally QD with 28 days each cycle, treatment till disease progression or intolerable toxicity or withdraw for other reasons
  • Drug 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
  • 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
  • Drug Abemaciclib 150 MG
    Dose: 150 mg Route: Orally Frequency: BID Schedule: Everyday
  • Drug Everolimus 10 mg
    Dose: 10 mg Route: Orally Frequency: QD Schedule: Everyday

Primary outcome measures

  • Phase Ib- Dose-Limiting Toxicity (DLT). [Time frame: Approximately 1.5 years]
  • Phase Ib- Maximum Tolerated Dose (MTD). [Time frame: Approximately 1.5 years]
  • Phase Ib- Recommended Phase II Dose (RP2D). [Time frame: Approximately 1.5 years]
  • Incidence of Treatment-Emergent Adverse Events (TEAEs) [Time frame: Approximately 2 years]
  • Severity Grading of Adverse Events [Time frame: Approximately 2 years]
  • Clinically Significant Abnormalities in 12-Lead ECG Parameters [Time frame: Approximately 2 years]
  • Vital Sign Abnormalities [Time frame: Approximately 2 years]
  • Serious Adverse Events (SAEs) Incidence [Time frame: Approximately 2 years]
  • Phase II- Investigator-assessed Objective Response Rate (ORR) based on RECIST v1.1. [Time frame: Approximately 2 years]
Secondary outcome measures (12)
  • Phase Ib- PK Assessment-Tmax [Time frame: Approximately 1.5 years]
  • Phase Ib- PK Assessment-Cmax [Time frame: Approximately 1.5 years]
  • Phase Ib- PK Assessment-AUC0-t [Time frame: Approximately 1.5 years]
  • Phase Ib- PK Assessment-AUC0-inf [Time frame: Approximately 1.5 years]
  • Phase Ib- PK Assessment-t1/2 [Time frame: Approximately 1.5 years]
  • Efficacy Assessment-ORR [Time frame: Approximately 2 years]
  • Efficacy Assessment-CBR [Time frame: Approximately 2 years]
  • Efficacy Assessment-DOR [Time frame: Approximately 2 years]
  • Efficacy Assessment-DCR [Time frame: Approximately 1.5 years]
  • Efficacy Assessment-PFS [Time frame: Approximately 2 years]
  • Efficacy Assessment-OS [Time frame: Approximately 2 years]
  • Pharmacokinetic (PK) Parameters:Plasma Concentration at Each Sampling Time Point. [Time frame: Approximately 2 years]

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:
  • 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.

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:
  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Fudan University Shanghai Cancer Center, Shanghai — Shanghai

Identifiers

NCT: NCT07002177 · FWD1802-002C

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗