NCT05189717

A Trial of HRS-8080 Tablets in Metastatic or Local Advanced Breast Cancer of Adults

A Single-arm, Open-label and Multi-center Phase I Study on Safety, Tolerance and Pharmacokinetics of HRS-8080 Tablets Monotherapy and Combined With Other Anti-cancer Therapy in Patients With Metastatic or Local Advanced Breast Cancer

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 156 (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 tolerance, and safety of HRS-8080 tablets monotherapy and combined with other anti-cancer therapy for metastatic or local advanced breast cancer in adults. To explore the reasonable dosage of HRS-8080 tablets for metastatic or local advanced breast cancer.

Conditions

• Metastatic or Local Advanced Breast Cancer of Patients

Interventions

Type	Name	Description
DRUG	HRS-8080 tablets、SHR 6390 tablets、Abemaciclib、Everolimus	During HRS-8080 monotherapy period, the dose of HRS-8080 would be increasing. In the combination therapy period, HRS-8080 will be administered at flat dose of RP2D-1 and RP2D.

Timeline

• Start date: 2022-02-17
• Primary completion: 2024-10-31
• Completion: 2025-07-31
• First posted: 2022-01-12
• Last updated: 2022-04-05

Locations

2 sites across 1 country: China