drugset / Trial / NCT06047184
Phase I Study of BEBT-209 in Women With Advanced Breast Cancer
Phase 1
Unknown
106 enrolled
BeBetter Med Inc
Hunan Cancer Hospital · collabXiangya Hospital of Central South University · collab
Non-randomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2019-07-15
- Primary completion
- 2023-10-20
- Completion
- 2023-11-20
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | BEBT-209 | Unknown | 25 mg | — |
| Subject | BEBT-209 | Unknown | 50 mg | — |
| Subject | BEBT-209 | Unknown | 75 mg | — |
| Subject | BEBT-209 | Unknown | 100 mg | — |
| Subject | BEBT-209 | Unknown | 150 mg | — |
| Subject | Fulvestrant | Small molecule | 500 mg | Other |
| Subject | Letrozole | Other / unclassified | 2.5 mg | — |