A Phase I/II Study of FWD1802 in Patients With ER+/HER2- Advanced BC.
Trial Parameters
Brief Summary
A Phase I/II, Open-label study to assess the safety, tolerability, pharmacokinetic, and antitumor efficacy of FWD1802 monotherapy in patients with ER+/HER2- unresectable locally advanced or metastatic breast cancer. This clinical trial aims to explore the role of FWD1802 in the ER+/HER2- advanced breast cancer patient population. The primary objectives are to address the following questions: Phase I Study: Determine the Recommended Phase II Dose (RP2D) and/or Maximum Tolerated Dose (MTD) of FWD1802 in patients with ER-positive, HER2-negative locally advanced or metastatic breast cancer. Phase II Study: To evaluate the efficacy of FWD1802 at the RP2D in patients with ESR1-mutated ER-positive/HER2-negative locally advanced or metastatic breast cancer, using objective response rate (ORR) as the efficacy endpoint.
Eligibility Criteria
Inclusion Criteria: Subjects must meet all of the following criteria to be eligible for enrollment in this clinical study: 1. Voluntarily participate in the clinical trial and sign the informed consent form. 2. Female, aged ≥18 years. 3. Able to provide blood samples for central laboratory testing of ESR1 mutation status and other biomarker assessments. Phase I Study: ESR1 mutation status will be tested retrospectively. Phase II Study: Only subjects with confirmed ESR1 mutations will be enrolled (see Appendix 5 for details). 4. Histologically or cytologically confirmed locally advanced or metastatic breast cancer that is ER-positive and HER2-negative. Criteria for ER positivity: Immunohistochemistry staining shows nuclear staining in ≥10% of tumor cells. Criteria for HER2 negativity: Immunohistochemistry staining intensity is 0 or 1+; if the intensity is 2+, it must be confirmed negative by in situ hybridization. 5. Confirmed in menopause and not caused by ovarian function suppression