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

NCT06047184 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 106

Last updated 2023-09-21

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Hunan Cancer Hospital

    collaborator OTHER

  • Xiangya Hospital of Central South University

    collaborator OTHER

  • BeBetter Med Inc

    lead INDUSTRY

Principal Investigators

  • Shouman Wang, Phd · Xiangya Hospital of Central South University

  • Quchang Ouyang, Phd · Hunan Cancer Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-15
Primary Completion
2023-10-20
Completion
2023-11-20

Countries

  • China

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06047184 on ClinicalTrials.gov