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

Primary Purpose

Metastatic or Local Advanced Breast Cancer of Patients

Status
Enrolling by invitation
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
HRS-8080 tablets、SHR 6390 tablets、Abemaciclib、Everolimus
Sponsored by
Shandong Suncadia Medicine Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metastatic or Local Advanced Breast Cancer of Patients

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Single Group

Arm Description

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.

Outcomes

Primary Outcome Measures

Maximum tolerated dose
The Maximum tolerated dose of HRS-8080 monotherapy or in combination with SHR-6390 / Abemaciclib / Everolimus
Recommended phase II dose
The Recommended phase II dose of HRS-8080 monotherapy or in combination with SHR-6390 / Abemaciclib / Everolimus
Incidence and severity of adverse events (AEs)/serious adverse events (SAEs)
Incidence and severity of adverse events (AEs)/serious adverse events (SAEs) graded by Common Terminology Criteria for Adverse Events (CTCAE) v5.0

Secondary Outcome Measures

Cmax
PK parameters of multiple doses of HRS-8080 monotherapy. HRS-8080 in combination therapy, SHR-6390, Abemaciclib and Everolimus.
Tmax
PK parameters of multiple doses of HRS-8080 monotherapy. HRS-8080 in combination therapy, SHR-6390, Abemaciclib and Everolimus. etc.
AUC0-t
PK parameters of multiple doses of HRS-8080 monotherapy. HRS-8080 in combination therapy, SHR-6390, Abemaciclib and Everolimus.
Cmax,ss
PK parameters of multiple doses of HRS-8080 monotherapy. HRS-8080 in combination therapy, SHR-6390, Abemaciclib and Everolimus.
Tmax,ss
PK parameters of multiple doses of HRS-8080 monotherapy. HRS-8080 in combination therapy, SHR-6390, Abemaciclib and Everolimus.
Cmin,ss
PK parameters of multiple doses of HRS-8080 monotherapy. HRS-8080 in combination therapy, SHR-6390, Abemaciclib and Everolimus.
AUCss
PK parameters of multiple doses of HRS-8080 monotherapy. HRS-8080 in combination therapy, SHR-6390, Abemaciclib and Everolimus.
Rac
PK parameters of multiple doses of HRS-8080 monotherapy. HRS-8080 in combination therapy, SHR-6390, Abemaciclib and Everolimus.
ORR
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
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
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
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
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

Full Information

First Posted
December 16, 2021
Last Updated
April 2, 2022
Sponsor
Shandong Suncadia Medicine Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05189717
Brief Title
A Trial of HRS-8080 Tablets in Metastatic or Local Advanced Breast Cancer of Adults
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
February 17, 2022 (Actual)
Primary Completion Date
October 31, 2024 (Anticipated)
Study Completion Date
July 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shandong Suncadia Medicine Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic or Local Advanced Breast Cancer of Patients

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Model Description
HRS-8080 tablets monotherapy and combined with other anti-cancer therapy
Masking
None (Open Label)
Allocation
N/A
Enrollment
156 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Single Group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
HRS-8080 tablets、SHR 6390 tablets、Abemaciclib、Everolimus
Intervention Description
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.
Primary Outcome Measure Information:
Title
Maximum tolerated dose
Description
The Maximum tolerated dose of HRS-8080 monotherapy or in combination with SHR-6390 / Abemaciclib / Everolimus
Time Frame
up to 28 days
Title
Recommended phase II dose
Description
The Recommended phase II dose of HRS-8080 monotherapy or in combination with SHR-6390 / Abemaciclib / Everolimus
Time Frame
up to 28 days
Title
Incidence and severity of adverse events (AEs)/serious adverse events (SAEs)
Description
Incidence and severity of adverse events (AEs)/serious adverse events (SAEs) graded by Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Time Frame
up to 30 days after the last dose
Secondary Outcome Measure Information:
Title
Cmax
Description
PK parameters of multiple doses of HRS-8080 monotherapy. HRS-8080 in combination therapy, SHR-6390, Abemaciclib and Everolimus.
Time Frame
0.5 hour before first dose of first treatment period to the 0.5 hour before first dose of fifth treatment period
Title
Tmax
Description
PK parameters of multiple doses of HRS-8080 monotherapy. HRS-8080 in combination therapy, SHR-6390, Abemaciclib and Everolimus. etc.
Time Frame
0.5 hour before first dose of first treatment period to the 0.5 hour before first dose of fifth treatment period
Title
AUC0-t
Description
PK parameters of multiple doses of HRS-8080 monotherapy. HRS-8080 in combination therapy, SHR-6390, Abemaciclib and Everolimus.
Time Frame
0.5 hour before first dose of first treatment period to the 0.5 hour before first dose of fifth treatment period
Title
Cmax,ss
Description
PK parameters of multiple doses of HRS-8080 monotherapy. HRS-8080 in combination therapy, SHR-6390, Abemaciclib and Everolimus.
Time Frame
0.5 hour before first dose of first treatment period to the 0.5 hour before first dose of fifth treatment period
Title
Tmax,ss
Description
PK parameters of multiple doses of HRS-8080 monotherapy. HRS-8080 in combination therapy, SHR-6390, Abemaciclib and Everolimus.
Time Frame
0.5 hour before first dose of first treatment period to the 0.5 hour before first dose of fifth treatment period
Title
Cmin,ss
Description
PK parameters of multiple doses of HRS-8080 monotherapy. HRS-8080 in combination therapy, SHR-6390, Abemaciclib and Everolimus.
Time Frame
0.5 hour before first dose of first treatment period to the 0.5 hour before first dose of fifth treatment period
Title
AUCss
Description
PK parameters of multiple doses of HRS-8080 monotherapy. HRS-8080 in combination therapy, SHR-6390, Abemaciclib and Everolimus.
Time Frame
0.5 hour before first dose of first treatment period to the 0.5 hour before first dose of fifth treatment period
Title
Rac
Description
PK parameters of multiple doses of HRS-8080 monotherapy. HRS-8080 in combination therapy, SHR-6390, Abemaciclib and Everolimus.
Time Frame
0.5 hour before first dose of first treatment period to the 0.5 hour before first dose of fifth treatment period
Title
ORR
Description
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
Time Frame
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
Title
BOR
Description
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
Time Frame
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
Title
DoR
Description
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
Time Frame
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
Title
DCR
Description
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
Time Frame
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
Title
PFS
Description
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
Time Frame
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: ECOG performance status score: 0-1; Histopathologically documented local advanced or metastatic breast cancer ; Female of not childbearing potential must the related requirement; During or after the last systematic therapy before enrolment, disease progression occurred with clinical or radiographical documentation; Adequate organ functions as defined; Ability to understand and voluntarily agrees to participate by giving written informed consent for the study. Exclusion Criteria: For the case of symptomatic visceral metastasis, the investigators judged that it was not suitable to use relevant treatment; 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 ; History of clinically significant cardiovascular or cerebrovascular diseases; The subject has one of many factors affecting oral drugs; Active infection or fever with unknown cause > 38.5 °C; Active autoimmune diseases, History of immunodeficiency, including positive HIV serum test result and other acquired or congenital immunodeficiency diseases, or history of organ transplantation; Known history of allergy to study drug ingredients.
Facility Information:
Facility Name
Fifth Medical Center of People's Liberation Army of China General Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100071
Country
China
Facility Name
Jilin Cancer Hospital
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130012
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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