Trials / Recruiting
RecruitingNCT07389733
A Study of HRS-6208 in Combination With HRS-8080, or Fulvestrant, or Letrozole, With or Without HRS-6209 in Patients With Advanced Unresectable or Metastatic Breast Cancer
Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of HRS-6208 in Combination With HRS-8080 ± HRS-6209, or in Combination With Fulvestrant ± HRS-6209, or in Combination With Letrozole ± HRS-6209 in Patients With Advanced Unresectable or Metastatic Breast Cancer: an Open Label, Multicenter, Phase Ib/II Study
- Status
- Recruiting
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 180 (estimated)
- Sponsor
- Shandong Suncadia Medicine Co., Ltd. · Industry
- Sex
- Female
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
This study aims to evaluate the safety, tolerability, efficacy and pharmacokinetics of HRS-6208 in combination with HRS-8080 ± HRS-6209, or in combination with fulvestrant ± HRS-6209, or in combination with letrozole ± HRS-6209 in patients with advanced unresectable or metastatic breast cancer.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | HRS-6208 Capsule | HRS-6208 capsule. |
| DRUG | HRS-6209 Capsule | HRS-6209 capsule. |
| DRUG | HRS-8080 Tablet | HRS-8080 tablet. |
| DRUG | Fulvestrant injection | Fulvestrant injection. |
| DRUG | Letrozole tablets | Letrozole tablets. |
Timeline
- Start date
- 2026-03-27
- Primary completion
- 2028-12-01
- Completion
- 2028-12-01
- First posted
- 2026-02-05
- Last updated
- 2026-04-03
Locations
2 sites across 1 country: China
Source: ClinicalTrials.gov record NCT07389733. Inclusion in this directory is not an endorsement.