A Phase I/II Study of FWD1802 in Patients With ER+/HER2- Advanced BC.

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. Pha

Trial Details

NCT ID
NCT06064812
Phase
PHASE1 / PHASE2
Sponsor
Forward Pharmaceuticals Co., Ltd.
Status
RECRUITING
Cancer Type
Breast Cancer
Interventions
  • FWD1802
Locations (sample)
  • Hefei, Anhui, China|31.86389,117.28083
  • Guangzhou, Guangdong, China|23.11667,113.25
  • Huizhou, Guangdong, China|23.11147,114.41523
  • Nanning, Guangxi, China|22.81667,108.31667
  • Luoyang, Henan, China|34.67345,112.43684

Key Eligibility Criteria

  • Subjects must meet all of the following criteria to be eligible for enrollment in this clinical study:
  • Voluntarily participate in the clinical trial and sign the informed consent form.
  • Female, aged ≥18 years.
  • Able to provide blood samples for central laboratory testing of ESR1 mutation status and other biomarker assessments. Phase I Study: ESR1 mutation …

For full eligibility, visit ClinicalTrials.gov.

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