NCT06047184

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

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

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 106 (estimated)
• Sponsor: BeBetter Med Inc · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Advanced Breast Cancer

Interventions

Type	Name	Description
DRUG	BEBT-209 capsules	BEBT-209 capsules, 25mg once daily, or 25mg, 50mg, 75mg, 100mg, 150mg each time, twice daily, were administered continuously for 3 weeks and discontinued for 1 week, and 4 weeks were used as a treatment cycle.
DRUG	Letrozole tablets	Letrozole tablets, 2.5mg each time, once a day for 4 weeks, 4 weeks as a treatment cycle.
DRUG	Fulvestrant	Fulvestrant, injection, 500mg each time, 1 time on day 1 and day 15 of the first cycle, and once on the first day of each cycle from the second cycle, 4 weeks as a treatment cycle

Timeline

• Start date: 2019-07-15
• Primary completion: 2023-10-20
• Completion: 2023-11-20
• First posted: 2023-09-21
• Last updated: 2023-09-21

Locations

2 sites across 1 country: China