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

NCT ID: NCT05189717

Last Updated: 2022-04-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 156 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-17
• Study Completion Date: 2025-07-31

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Single Group

Firstly Dose Escalation and Dose Expansion of HRS-8080 monotherapy should be conducted. After RP2D and MTD of the HRS-8080 monotherapy were confirmed, Dose Escalation and Dose Extension of HRS-8080 in combination with other anti-cancer treatment would be completed, including SHR 6390, or Abemaciclib, or Everolimus.

Group Type: EXPERIMENTAL

HRS-8080 tablets、SHR 6390 tablets、Abemaciclib、Everolimus

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. ECOG performance status score: 0-1;

2. Histopathologically documented local advanced or metastatic breast cancer ;

3. Female of not childbearing potential must the related requirement;

4. During or after the last systematic therapy before enrolment, disease progression occurred with clinical or radiographical documentation;

5. Adequate organ functions as defined;

6. Ability to understand and voluntarily agrees to participate by giving written informed consent for the study.

Exclusion Criteria

1. For the case of symptomatic visceral metastasis, the investigators judged that it was not suitable to use relevant treatment;

2. patients with active brain metastasis (without medical control or with clinical symptoms), cancerous meningitis, spinal cord compression, or patients with a history of primary tumors of the central nervous system ;

3. History of clinically significant cardiovascular or cerebrovascular diseases;

4. The subject has one of many factors affecting oral drugs;

5. Active infection or fever with unknown cause > 38.5 °C;

6. Active autoimmune diseases, History of immunodeficiency, including positive HIV serum test result and other acquired or congenital immunodeficiency diseases, or history of organ transplantation;

7. Known history of allergy to study drug ingredients.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Shandong Suncadia Medicine Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Fifth Medical Center of People's Liberation Army of China General Hospital

Beijing, Beijing Municipality, China

Jilin Cancer Hospital

Changchun, Jilin, China

Countries

China

Other Identifiers

HRS-8080-I-101

Identifier Type: -

Identifier Source: org_study_id