Trials / Recruiting
RecruitingNCT05628870
A Trial of HRS-1358 Tablets in Metastatic or Local Advanced Breast Cancer
A Single-arm, Open-label, Multi-center Phase I Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of HRS-1358 Monotherapy or Combination With Dalpiciclib Isethionate Tablets in Patients With Metastatic or Locally Advanced Breast Cancer.
- Status
- Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 102 (estimated)
- Sponsor
- Shandong Suncadia Medicine Co., Ltd. · Industry
- Sex
- Female
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
The study is being conducted to evaluate the safety and tolerability of HRS-1358 monotherapy or combination with Dalpiciclib Isethionate Tablets in patients with metastatic or locally advanced breast cancer in order to estimate the Dose-Limiting Toxicity (DLT), Maximum Tolerated Dose (MTD) and select the Recommended Phase 2 Dose (RP2D).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | HRS-1358 | HRS-1358 or combination with Dalpiciclib Isethionate Tablets will be administered daily orally in continuous dosing over 28-day cycles. |
Timeline
- Start date
- 2023-02-07
- Primary completion
- 2025-06-01
- Completion
- 2025-06-30
- First posted
- 2022-11-29
- Last updated
- 2025-03-17
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT05628870. Inclusion in this directory is not an endorsement.