Trials / Unknown
UnknownNCT05927779
Study of TFX06 in Women With Advanced Breast Cancer.
Phase I/II Clinical Study to Evaluate the Safety, Tolerance, Efficacy and Pharmacokinetics of TFX06 Tablet in ER Positive, HER Negative Locally Advanced or Metastatic Breast Cancer.
- Status
- Unknown
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 74 (estimated)
- Sponsor
- Zhejiang Yangli Pharmaceutical Technology Co., Ltd. · Industry
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
A Phase 1/2 Dose Escalation and Expansion Study of TFX06 tablet Alone in Women with ER Positive, HER2 Negative Advanced Breast Cancer
Detailed description
This is a phase Ⅰ/Ⅱ, open-label study of TFX06 tablet single agent to assess the safety and tolerability, identify an Maximum Tolerated Dose （MTD）, and/or RP2D, evaluate the pharmacokinetic（PK ）properties and evaluate preliminary anti-tumor activities in women with advanced or metastatic ER-positive, HER2-negative breast cancer.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | TFX06 tablet | TFX06 tablet taken orally |
Timeline
- Start date
- 2023-04-17
- Primary completion
- 2024-12-30
- Completion
- 2025-04-30
- First posted
- 2023-07-03
- Last updated
- 2023-07-03
Locations
2 sites across 1 country: China
Source: ClinicalTrials.gov record NCT05927779. Inclusion in this directory is not an endorsement.