Phase I Study of BEBT-209 in Women With Advanced Breast Cancer

Advanced Breast Cancer Clinical Trial

Official title: A Phase I, Open, Multicenter Study of BEBT-209 in Women With Advanced Breast Cancer

Status Active, not recruiting

Clinical Trial Summary

This clinical study includes a dose escalation trial of BEBT-209 monotherapy in HR +/HER2- advanced breast cancer patients and a Phase 1b trial of BEBT-209 as a single therapy, in combination with letrozole, and in combination with fulvestrant in ER +/HER2- advanced breast cancer in women. To evaluate the safety, tolerability, pharmacokinetic profile, and preliminary efficacy of BEBT-209 as a single therapy, in combination with letrozole, and in combination with fulvestrant. To determine the recommended dose for late clinical studies of monotherapy or combination therapy in patients with HR +/HER2- advanced breast cancer.

Clinical Trial Description

• Dose escalation phase: To conduct approximately 6 dose levels, with a starting dose of 25 mg/day of BEBT-209, and subsequent dose groups were first dose escalated at 100%, with dose escalation at 50% for subsequent dose groups if one drug-related Grade 2 nonhematologic or Grade 3 hematologic toxicity was identified and dose-limiting toxicity was not reached. If one dose limiting toxicity was identified and the maximum tolerated dose was not reached, dose escalation was performed at 33% for the subsequent dose groups.

• Phase Ib of BEBT-209 as single therapy, in Combination with Letrozole, in Combination with Fulvestrant: According to the pharmacokinetics, safety and preliminary efficacy of BEBT-209 in the dose escalation phase, one dose was selected for the BEBT-209 monotherapy group, two doses were selected for the combination with letrozole group, and two doses were selected for the combination with fulvestrant group, and all five groups were continuously administered until disease progression or unacceptable toxicity or patient withdrawal or death. Late phase clinical trials were conducted as appropriate based on preliminary safety tolerability, pharmacokinetics, and preliminary efficacy results from Phase 1b.

Participants will need to understand the requirements and risks of the trial, sign an informed consent form, accept the dosing regimen required by the trial protocol, and follow the investigator's guidance. ;

Related Conditions & MeSH terms

• Advanced Breast Cancer
• Breast Neoplasms

• NCT number: NCT06047184
• Study type: Interventional
• Source: BeBetter Med Inc
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: July 15, 2019
• Completion date: November 20, 2023