OncoMatch/Clinical Trials/NCT06064812
A Phase I/II Study of FWD1802 in Patients With ER+/HER2- Advanced BC.
Is NCT06064812 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies FWD1802 for metastatic breast cancer.
Treatment: FWD1802 — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Biomarker criteria
Required: ESR1 mutation
Phase II Study: Only subjects with confirmed ESR1 mutations will be enrolled
Required: ESR1 expression (Immunohistochemistry staining shows nuclear staining in ≥10% of tumor cells)
Criteria for ER positivity: Immunohistochemistry staining shows nuclear staining in ≥10% of tumor cells.
Required: HER2 (ERBB2) negative (IHC 0 or 1+; if 2+, must be ISH negative)
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.
Disease stage
Required: Stage III, IV
locally advanced or metastatic breast cancer
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: endocrine therapy — adjuvant or advanced
Disease progression during or intolerance to standard therapy, or unsuitability for standard therapy. Previous adjuvant endocrine therapy for at least 2 years, with recurrence during treatment or within 1 year after completion; OR at least one line of endocrine therapy for the advanced stage, with progression after at least 6 months of maintenance therapy on any line of advanced endocrine therapy (no limit on the number of endocrine therapy lines).
Cannot have received: selective estrogen receptor degrader
Exception: fulvestrant
Prior use of any selective estrogen receptor degrader (other than fulvestrant) or investigational drugs inhibiting the ER signaling pathway.
Lab requirements
Blood counts
ANC ≥ 1.5 × 10⁹/L; WBC ≥ 3.0 × 10⁹/L and ≤ 15 × 10⁹/L; PLT ≥ 100 × 10⁹/L; HGB ≥ 100 g/L.
Kidney function
Serum creatinine (Scr) ≤ 1.5 × ULN OR creatinine clearance (Clcr) ≥ 50 mL/min.
Liver function
Serum total bilirubin (TBIL) ≤ 1.5 × ULN. For subjects without liver metastases: ALT and AST ≤ 3 × ULN. For subjects with liver metastases: ALT and AST ≤ 5 × ULN.
Cardiac function
LVEF > 50% as shown by echocardiography.
Subjects must have adequate organ and bone marrow function at screening (no blood transfusion, human albumin administration, or use of hematopoietic growth factors within 7 days prior to screening tests), defined as follows: [see above for details]
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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