A Phase I/II Study of FWD1802 in Patients With ER+/HER2- Advanced BC.
A Phase I/II, Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Anti-tumor Efficacy of FWD1802in Patients With ER+/HER2- Unresectable Locally Advanced or Metastatic Breast Cancer
Forward Pharmaceuticals Co., Ltd.
99 participants
Sep 12, 2023
INTERVENTIONAL
Conditions
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
Plain Language Summary
Simplified for easier understanding
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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Interventions
Eligible subjects will receive FWD1802 treatment according to their assigned dose cohort. Dose Escalation Phase: This phase is divided into a Single-Agent Lead-in Period (C0) and a Multiple-Dosing Period (C1). During the single-agent lead-in period, subjects will receive one dose on Day 1, followed by a 6-day dosing pause. In the multiple-dosing period, subjects will be administered FWD1802 once daily. Dose Expansion Phase: Subjects will receive FWD1802 once daily. Each 4-week period constitutes one treatment cycle. Treatment will continue for up to 2 years or until one of the following events occurs (whichever comes first): disease progression, intolerable toxicity, withdrawal of informed consent, loss to follow-up, initiation of new anti-cancer therapy, or death. Patients who remain in the study at the end of the 2-year treatment period and continue to derive clinical benefit may, upon agreement between the investigator and the sponsor, have the option to continue treatment.
Locations(22)
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NCT06064812