Combining FWD1802 with CDK4/6 inhibitors or everolimus for ER+/HER2- advanced breast cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase Ib/II interventional study explores multiple combination regimens pairing the investigational agent FWD1802 with approved targeted therapies (palbociclib, ribociclib, abemaciclib, or everolimus) in patients with ER+/HER2- locally advanced or metastatic breast cancer. Dose-finding and safety lead the early phase portions, with expansion cohorts to measure anti-tumor activity and biomarkers. Participants must provide blood for centralized ESR1 mutation and other biomarker testing and meet prior-therapy criteria related to endocrine treatment. The study is single-site listed at Fudan University Shanghai Cancer Center and enrolls patients who can comply with the protocol and required sample collection.

Why it matters

Who can join: the full rules

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

Where it's running

• Fudan University Shanghai Cancer Center, Shanghai
  Shanghai, China Recruiting

Study contacts

• Study coordinator: Jinglin Xu
• Email: xujl@forward-pharm.com
• Phone: 18964533182

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.