Trials / Unknown
UnknownNCT05337657
A Phase Ib Study of GB491 Plus Letrozole in Patients With Advanced Breast Cancer
A Multicenter, Open-label, Phase Ib Clinical Trial of GB491 in Combination With Letrozole in Previously Untreated Patients With HR-positive, HER2-negative Advanced Breast Cancer
- Status
- Unknown
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 10 (estimated)
- Sponsor
- Genor Biopharma Co., Ltd. · Industry
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
GB491-005 is a multicenter, open-label, phase Ib Clinical Trial study to evaluate the safety, pharmacokinetic (PK), pharmacodynamic (PD) activity, and preliminary anti-tumor activity of GB491 in combination with Letrozole in Previously Untreated Patients with HR-positive, HER2-negative Advanced Breast Cancer
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | GB491+Letrozole | Drug：The dose of GB491 is 150 mg, which should be taken with a meal and taken twice daily at approximately the same time each day, approximately 12 hours apart |
Timeline
- Start date
- 2021-06-02
- Primary completion
- 2023-12-12
- Completion
- 2024-02-01
- First posted
- 2022-04-20
- Last updated
- 2022-04-20
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT05337657. Inclusion in this directory is not an endorsement.