A Multi-center, Open-label Phase Ib/II Clinical Study on the Safety, Tolerability, Pharmacokinetics and Efficacy of HRS-8080 or SHR-A2009 Combined With Anti-tumor Therapy in Patients With Unresectable or Metastatic Breast Cancer

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY

This study is designed to determine if treatments with the combination of HRS-8080 and SHR-A1811, the combination of HRS-8080 and SHR-A2009, the combination of SHR-A2009 and SHR-1316 are safe, tolerable, and has anti-cancer activity in patients with unresectable or metastatic breast cancer.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• Females aged 18-75 years old (both ends inclusive);

• ECOG performance status (PS) 0-1 points;

• Patients with metastatic or locally advanced breast cancer confirmed by histology(ER positive, HER2 positive/negative,or triple negative breast cancer).

• Tumor tissue samples must be provided for detection of tumor markers;

• Menopausal state;

• Disease progression confirmed by imaging during or after the last systemic treatment before enrollment;

• There must be at least one measurable extracranial lesion that complies with RECIST v1.1;

• Expected survival \>3 months;

• Good functional level of the organs ;

⁃ Female subjects with childbearing potential must agree to use highly effective contraceptive measures during the study treatment period and within 7 months after the end of the study treatment period; female subjects with childbearing potential must agree to use serum serum within 7 days before study enrollment. The HCG test must be negative and the patient must be non-lactating;

⁃ Voluntarily participate in this clinical trial, be willing and able to comply with clinical visits and research-related procedures, understand the research procedures and have signed informed consent.

Locations
Other Locations
China
Hunan Cancer Hospital
RECRUITING
Changsha
Contact Information
Primary
Na An
na.an@hengrui.com
+86 18500038119
Time Frame
Start Date: 2024-02-20
Estimated Completion Date: 2026-10-31
Participants
Target number of participants: 350
Treatments
Experimental: Part A
Experimental: Part B
Experimental: Part C
Related Therapeutic Areas
Sponsors
Leads: Shandong Suncadia Medicine Co., Ltd.

This content was sourced from clinicaltrials.gov

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