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

Phase 1

• Conditions: Metastatic or Local Advanced Breast Cancer of Patients
• Interventions: Drug: HRS-8080 tablets、SHR 6390 tablets、Abemaciclib、Everolimus

• Registration Number: NCT05189717
• Lead Sponsor: Shandong Suncadia Medicine Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-12-16
• Study First Submitted QC: 2021-12-30
• Study First Posted: 2022-01-12
• Study Start: 2022-02-17
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-02
• Last Update Posted: 2022-04-05
• Primary Completion: 2024-10-31
• Study Completion: 2025-07-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: Female
• Target Recruitment: 156

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single Group	HRS-8080 tablets、SHR 6390 tablets、Abemaciclib、Everolimus	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.

Primary Outcome Measures

Name	Time	Method
Incidence and severity of adverse events (AEs)/serious adverse events (SAEs)	up to 30 days after the last dose	Incidence and severity of adverse events (AEs)/serious adverse events (SAEs) graded by Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Recommended phase II dose	up to 28 days	The Recommended phase II dose of HRS-8080 monotherapy or in combination with SHR-6390 / Abemaciclib / Everolimus
Maximum tolerated dose	up to 28 days	The Maximum tolerated dose of HRS-8080 monotherapy or in combination with SHR-6390 / Abemaciclib / Everolimus

Secondary Outcome Measures

Name	Time	Method
AUCss	0.5 hour before first dose of first treatment period to the 0.5 hour before first dose of fifth treatment period	PK parameters of multiple doses of HRS-8080 monotherapy. HRS-8080 in combination therapy, SHR-6390, Abemaciclib and Everolimus.
Cmin,ss	0.5 hour before first dose of first treatment period to the 0.5 hour before first dose of fifth treatment period	PK parameters of multiple doses of HRS-8080 monotherapy. HRS-8080 in combination therapy, SHR-6390, Abemaciclib and Everolimus.
Cmax	0.5 hour before first dose of first treatment period to the 0.5 hour before first dose of fifth treatment period	PK parameters of multiple doses of HRS-8080 monotherapy. HRS-8080 in combination therapy, SHR-6390, Abemaciclib and Everolimus.
Tmax	0.5 hour before first dose of first treatment period to the 0.5 hour before first dose of fifth treatment period	PK parameters of multiple doses of HRS-8080 monotherapy. HRS-8080 in combination therapy, SHR-6390, Abemaciclib and Everolimus. etc.
AUC0-t	0.5 hour before first dose of first treatment period to the 0.5 hour before first dose of fifth treatment period	PK parameters of multiple doses of HRS-8080 monotherapy. HRS-8080 in combination therapy, SHR-6390, Abemaciclib and Everolimus.
Cmax,ss	0.5 hour before first dose of first treatment period to the 0.5 hour before first dose of fifth treatment period	PK parameters of multiple doses of HRS-8080 monotherapy. HRS-8080 in combination therapy, SHR-6390, Abemaciclib and Everolimus.
Tmax,ss	0.5 hour before first dose of first treatment period to the 0.5 hour before first dose of fifth treatment period	PK parameters of multiple doses of HRS-8080 monotherapy. HRS-8080 in combination therapy, SHR-6390, Abemaciclib and Everolimus.
Rac	0.5 hour before first dose of first treatment period to the 0.5 hour before first dose of fifth treatment period	PK parameters of multiple doses of HRS-8080 monotherapy. HRS-8080 in combination therapy, SHR-6390, Abemaciclib and Everolimus.
ORR	from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 8 months	Objective Response Rate, Preliminary Efficacy endpoints of HRS-8080 monotherapy or in combination with SHR-6390, Abemaciclib or Everolimus in treatment of patients with metastatic or local advanced breast cancer
BOR	from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 8 months	Best Overall Response, Preliminary Efficacy endpoints of HRS-8080 monotherapy or in combination with SHR-6390, Abemaciclib or Everolimus in treatment of patients with metastatic or local advanced breast cancer
DoR	from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 8 months	Duration of response, Preliminary Efficacy endpoints of HRS-8080 monotherapy or in combination with SHR-6390, Abemaciclib or Everolimus in treatment of patients with metastatic or local advanced breast cancer
DCR	from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 8 months	Disease control rate, Preliminary Efficacy endpoints of HRS-8080 monotherapy or in combination with SHR-6390, Abemaciclib or Everolimus in treatment of patients with metastatic or local advanced breast cancer
PFS	from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 8 months	Progression-free survival, Preliminary Efficacy endpoints of HRS-8080 monotherapy or in combination with SHR-6390, Abemaciclib or Everolimus in treatment of patients with metastatic or local advanced breast cancer

Trial Locations

Locations (2)

Fifth Medical Center of People's Liberation Army of China General Hospital; 🇨🇳 Beijing, Beijing, China

Jilin Cancer Hospital; 🇨🇳 Changchun, Jilin, China