Ignite Creation Date:
2024-05-06 @ 7:32 PM
Last Modification Date:
2024-10-26 @ 3:08 PM
Study NCT ID:
NCT06047184
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-09-21
First Post:
2023-09-07
Brief Title:
Phase I Study of BEBT-209 in Women With Advanced Breast Cancer
Sponsor:
BeBetter Med Inc
Organization:
BeBetter Med Inc
Study Overview
Official Title:
A Phase I Open Multicenter Study of BEBT-209 in Women With Advanced Breast Cancer
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 mgday 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 investigators guidance
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 investigators guidance
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None