OncoMatch/Clinical Trials/NCT06064812
A Phase I/II Study of FWD1802 in Patients With ER+/HER2- Advanced BC.
Is NCT06064812 recruiting? Yes, currently enrolling (Jun 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
Treatments studied
Other
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)
Demographics
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.
Frequently asked questions
Is NCT06064812 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior selective estrogen receptor degrader disqualifies patients from enrollment.
Does this trial require ESR1?
Yes, ESR1 mutation is a required biomarker for enrollment.
Does this trial require ESR1?
Yes, ESR1 expression is a required biomarker for enrollment.
Does this trial require ERBB2?
Yes, ERBB2 negative is a required biomarker for enrollment.
What disease stage is eligible?
Stage III or IV is required.
Is this trial open to male patients?
No. This trial enrolls female patients only.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
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