NCT06685796

A Study of BEBT-209 in Combination With Chemotherapy for the Treatment of Advanced Triple-Negative Breast Cancer

A Phase II Study of BEBT-209 in Combination With Carboplatin and Gemcitabine for the Treatment of Advanced Triple-Negative Breast Cancer

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: BeBetter Med Inc · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter, open-label, two-stage Phase II clinical study to evaluate the safety and efficacy of BEBT-209 capsule in combination with carboplatin and gemcitabine for the treatment of advanced triple-negative breast cancer (TNBC).

Detailed description

This study is designed with a total of 3 cohorts, enrolling patients with advanced triple-negative breast cancer. Subjects are randomly assigned to each cohort in a 1:1:1 ratio. Each cohort initially enrolls no fewer than 8 subjects for safety assessment, with the assessment period being the first cycle of medication (21 days). If the overall safety assessment is tolerable, the enrollment will be expanded to 30-40 subjects. During the trial, if the subjects in any of the above cohorts are unable to tolerate the treatment or there is no clinical benefit, the enrollment for that cohort will be terminated promptly. Dosing Regimen Exploration Stage: A total of 3 cohorts are designed, namely Cohort 1, Cohort 2, and Cohort 3. Cohort 1 receives carboplatin and gemcitabine treatment, with medication administered on days 1 and 8 of each cycle, with a 21-day cycle; Cohort 2 receives BEBT-209 capsules + chemotherapy (carboplatin and gemcitabine), with medication administered on days 1, 2, 8, and 9 of each cycle, with a 21-day cycle, where on days 1 and 8, BEBT-209 capsules 150mg are administered orally only before dinner, and on days 2 and 9, BEBT-209 capsules 150mg are administered orally before breakfast on the day of chemotherapy, along with carboplatin and gemcitabine treatment; Cohort 3 receives BEBT-209 capsules + chemotherapy (carboplatin and gemcitabine), with medication administered on days 1, 2, 8, and 9 of each cycle, with a 21-day cycle, where on days 1 and 8, BEBT-209 capsules are administered orally only (150mg，twice a day, before breakfast and before dinner), and on days 2 and 9, BEBT-209 capsules 150mg are administered orally before breakfast on the day of chemotherapy, along with carboplatin and gemcitabine treatment. If the safety assessment deems the BEBT-209 dosing regimen in Cohort 2 and Cohort 3 to be intolerable, the investigators may adjust the dosing regimen design for BEBT-209 capsules. Expansion Stage: Investigators determine the expansion cohort for a specific dosing regimen based on the combined results of safety and pharmacodynamics observed in the dosing regimen exploration stage, further exploring the safety and efficacy of BEBT-209 capsules in combination with carboplatin and gemcitabine for the treatment of advanced triple-negative breast cancer. The study process for each subject includes three periods: the screening period, the treatment period, and the post-treatment follow-up period. The screening period lasts up to 28 days. Subjects who meet the inclusion criteria and do not meet the exclusion criteria will be enrolled to receive treatment in a 21-day treatment cycle. Hematological assessments are conducted before and after each cycle of chemotherapy, and an overall safety assessment is conducted according to the protocol during the study period; after the first dose during the treatment period, the first two tumor assessments are conducted every 9 weeks, and from the third assessment onward, every 12 weeks. Participants can continue to receive the study medication until disease progression (PD), death, intolerable toxicity, or withdrawal of informed consent (whichever occurs first).

Conditions

• Advanced Triple-Negative Breast Cancer

Interventions

Type	Name	Description
DRUG	BEBT-209 capsules	BEBT-209 Capsules, dosage: 150mg, frequency and duration of administration: administered on days 1, 2, 8, and 9 of each cycle, with a 21-day cycle. On days 1 and 8, take orally once before dinner or twice (before breakfast and before dinner), and on days 2 and 9, take orally once before breakfast.
DRUG	Carboplatin injection	Carboplatin injection, dosage: AUC 2 × (creatinine clearance rate + 25), frequency and duration of administration: administered on days 1 and 8 or days 2 and 9 of each cycle, with a 21-day cycle.
DRUG	Gemcitabine hydrochloride for injection	Gemcitabine hydrochloride for injection, dosage: 1000mg/m², frequency and duration of administration: administered on days 1 and 8 or days 2 and 9 of each cycle, with a 21-day cycle.

Timeline

• Start date: 2023-04-12
• Primary completion: 2026-06-30
• Completion: 2026-12-31
• First posted: 2024-11-13
• Last updated: 2024-11-13

Locations

2 sites across 1 country: China