Back to resultsA Phase 1 Study of HRS8807 Monotherapy and in Combination With SHR6390 in Subjects With ER-Positive, HER2-Negative Metastatic or Locally Advanced Breast Cancer
Primary Purpose
ER-Positive, HER2-Negative Breast Cancer
Status
Recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
HRS8807
HRS8807
HRS8807、SHR6390
HRS8807、SHR6390
Sponsored by
About this trial
This is an interventional treatment trial for ER-Positive, HER2-Negative Breast Cancer
Eligibility Criteria
Inclusion Criteria:
- Histological diagnosis of metastatic or locally advanced breast cancer; Histologically proven diagnosis of ER-positive, HER2-negative;
- At least 1 line of endocrine therapy in the metastatic or advanced setting that had progressed or intolerance; ≤ 2 lines of chemotherapy for metastatic or advanced disease;
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1;
- Expected survival of more than 3 months.
Exclusion Criteria:
- All patients in monotherapy and or in combination wih phase who are known allergic to HRS8807 or SHR6390 ingredient;
- Presence of symptomatic metastatic visceral disease ;
- Patients with known active brain metastases;
- Clinically serious cardiovascular disease;
- Abnormal electrocardiographic (ECG) with clinical significancy by investigator judgement;
- Abnormal thyroid function laboratory results;
- Active infection or unexplained fever >38.5℃ during screening period or on the day of the first dose.
Sites / Locations
- Fudan University Shanghai Cancer CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
Group A
Group B
Group C
Group D
Arm Description
HRS8807 monotherapy dose escalation
HRS8807 monotherapy dose expansion
HRS8807 in combination with SHR6390 dose escalation
HRS8807 in combination with SHR6390 dose expansion
Outcomes
Primary Outcome Measures
MTD
Maximum Tolerated Dose (MTD) of HRS8807 monotherapy and in combination with SHR6390
RP2D
select the Recommended Phase 2 Dose (RP2D) of HRS8807 monotherapy and in combination with SHR6390
Adverse events (AE) and serious AE (SAE)
AEs and SAEs as characterized by frequency and severity (as graded by National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE version 5.0]).
Secondary Outcome Measures
Tmax of HRS8807 and the major metabolite after single dose of HRS8807
Cmax of HRS8807 and the major metabolite after single dose of HRS8807
AUC0-t of HRS8807 and the major metabolite after single dose of HRS8807
AUC0-∞ of HRS8807 and the major metabolite after single dose of HRS8807
t1/2 of HRS8807 and the major metabolite after single dose of HRS8807
Vz/F of HRS8807 and the major metabolite after single dose of HRS8807
CL/F of HRS8807 and the major metabolite after single dose of HRS8807
Tmax,ss of HRS8807 and the major metabolite after multiple dose administration of HRS8807
Cmax,ss of HRS8807 and the major metabolite after multiple dose administration of HRS8807
Cmin,ss of HRS8807 and the major metabolite after multiple dose administration of HRS8807
Rac of HRS8807 and the major metabolite after multiple dose administration of HRS8807
AUCss of HRS8807 and the major metabolite after multiple dose administration of HRS8807
Tmax of HRS8807, the major metabolite and SHR6390 after single dose administration of HRS8807 and SHR6390
Cmax of HRS8807, the major metabolite and SHR6390 after single dose administration of HRS8807 and SHR6390
AUC0-t of HRS8807, the major metabolite and SHR6390 after single dose administration of HRS8807 and SHR6390
Tmax,ss of HRS8807, the major metabolite and SHR6390 after multiple dose administration of HRS8807 and SHR6390
Cmax,ss of HRS8807, the major metabolite and SHR6390 after multiple dose administration of HRS8807 and SHR6390
Cmin,ss of HRS8807, the major metabolite and SHR6390 after multiple dose administration of HRS8807 and SHR6390
AUCss of HRS8807, the major metabolite and SHR6390 after multiple dose administration of HRS8807 and SHR6390
Rac of HRS8807, the major metabolite and SHR6390 after multiple dose administration of HRS8807 and SHR6390
Objective Response Rate (ORR)
Duration of Response (DoR)
Progression Free Survival (PFS)
Full Information
NCT ID
NCT04993430
First Posted
July 20, 2021
Last Updated
November 15, 2021
Sponsor
Shanghai Hengrui Pharmaceutical Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT04993430
Brief Title
A Phase 1 Study of HRS8807 Monotherapy and in Combination With SHR6390 in Subjects With ER-Positive, HER2-Negative Metastatic or Locally Advanced Breast Cancer
Official Title
A Phase 1, Single Arm, Open-Label, Multicenter Study to Evaluate the Safety, Tolerability and Pharmacokinetic of HRS8807 Monotherapy and in Combination With SHR6390 in Subjects With ER-Positive, HER2-Negative Metastatic or Locally Advanced Breast Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Recruiting
Study Start Date
October 26, 2021 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Hengrui Pharmaceutical 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 to assess safety and tolerability of HRS8807 monotherapy and in combination with SHR6390 in subjects with metastatic or locally advanced breast cancer in order to estimate the Dose-Limiting Toxicity (DLT), Maximum Tolerated Dose (MTD) and select the Recommended Phase 2 Dose (RP2D).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ER-Positive, HER2-Negative Breast Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Model Description
HRS8807 monotherapy and in combination with SHR6390
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group A
Arm Type
Experimental
Arm Description
HRS8807 monotherapy dose escalation
Arm Title
Group B
Arm Type
Experimental
Arm Description
HRS8807 monotherapy dose expansion
Arm Title
Group C
Arm Type
Experimental
Arm Description
HRS8807 in combination with SHR6390 dose escalation
Arm Title
Group D
Arm Type
Experimental
Arm Description
HRS8807 in combination with SHR6390 dose expansion
Intervention Type
Drug
Intervention Name(s)
HRS8807
Intervention Description
HRS8807 monotherapy
Intervention Type
Drug
Intervention Name(s)
HRS8807
Intervention Description
HRS8807 monotherapy
Intervention Type
Device
Intervention Name(s)
HRS8807、SHR6390
Intervention Description
HRS8807 in combination with SHR6390
Intervention Type
Drug
Intervention Name(s)
HRS8807、SHR6390
Intervention Description
HRS8807 in combination with SHR6390
Primary Outcome Measure Information:
Title
MTD
Description
Maximum Tolerated Dose (MTD) of HRS8807 monotherapy and in combination with SHR6390
Time Frame
Change From Baseline at 28 days
Title
RP2D
Description
select the Recommended Phase 2 Dose (RP2D) of HRS8807 monotherapy and in combination with SHR6390
Time Frame
Change From Baseline at 28 days
Title
Adverse events (AE) and serious AE (SAE)
Description
AEs and SAEs as characterized by frequency and severity (as graded by National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE version 5.0]).
Time Frame
Up to 30 days after end of treatment
Secondary Outcome Measure Information:
Title
Tmax of HRS8807 and the major metabolite after single dose of HRS8807
Time Frame
Day 1, Day 2, Day 3 of single dose (3 days before Cycle1)
Title
Cmax of HRS8807 and the major metabolite after single dose of HRS8807
Time Frame
Day 1, Day 2, Day 3 of single dose (3 days before Cycle1)
Title
AUC0-t of HRS8807 and the major metabolite after single dose of HRS8807
Time Frame
Day 1, Day 2, Day 3 of single dose (3 days before Cycle1)
Title
AUC0-∞ of HRS8807 and the major metabolite after single dose of HRS8807
Time Frame
Day 1, Day 2, Day 3 of single dose (3 days before Cycle1)
Title
t1/2 of HRS8807 and the major metabolite after single dose of HRS8807
Time Frame
Day 1, Day 2, Day 3 of single dose (3 days before Cycle1)
Title
Vz/F of HRS8807 and the major metabolite after single dose of HRS8807
Time Frame
Day 1, Day 2, Day 3 of single dose (3 days before Cycle1)
Title
CL/F of HRS8807 and the major metabolite after single dose of HRS8807
Time Frame
Day 1, Day 2, Day 3 of single dose (3 days before Cycle1)
Title
Tmax,ss of HRS8807 and the major metabolite after multiple dose administration of HRS8807
Time Frame
Cycle 1 Day 14, Day 15, each cycle is 28 days
Title
Cmax,ss of HRS8807 and the major metabolite after multiple dose administration of HRS8807
Time Frame
Cycle 1 Day 14, Day 15, each cycle is 28 days
Title
Cmin,ss of HRS8807 and the major metabolite after multiple dose administration of HRS8807
Time Frame
Cycle 1 Day 14, Day 15, each cycle is 28 days
Title
Rac of HRS8807 and the major metabolite after multiple dose administration of HRS8807
Time Frame
Cycle 1 Day 14, Day 15, each cycle is 28 days
Title
AUCss of HRS8807 and the major metabolite after multiple dose administration of HRS8807
Time Frame
Cycle 1 Day 14, Day 15, each cycle is 28 days
Title
Tmax of HRS8807, the major metabolite and SHR6390 after single dose administration of HRS8807 and SHR6390
Time Frame
Cycle 1 Day 1, Day 2, each cycle is 28 days
Title
Cmax of HRS8807, the major metabolite and SHR6390 after single dose administration of HRS8807 and SHR6390
Time Frame
Cycle 1 Day 1, Day 2, each cycle is 28 days
Title
AUC0-t of HRS8807, the major metabolite and SHR6390 after single dose administration of HRS8807 and SHR6390
Time Frame
Cycle 1 Day 1, Day 2, each cycle is 28 days
Title
Tmax,ss of HRS8807, the major metabolite and SHR6390 after multiple dose administration of HRS8807 and SHR6390
Time Frame
Cycle 1 Day 14, Day 15, each cycle is 28 days
Title
Cmax,ss of HRS8807, the major metabolite and SHR6390 after multiple dose administration of HRS8807 and SHR6390
Time Frame
Cycle 1 Day 14, Day 15, each cycle is 28 days
Title
Cmin,ss of HRS8807, the major metabolite and SHR6390 after multiple dose administration of HRS8807 and SHR6390
Time Frame
Cycle 1 Day 14, Day 15, each cycle is 28 days
Title
AUCss of HRS8807, the major metabolite and SHR6390 after multiple dose administration of HRS8807 and SHR6390
Time Frame
Cycle 1 Day 14, Day 15, each cycle is 28 days
Title
Rac of HRS8807, the major metabolite and SHR6390 after multiple dose administration of HRS8807 and SHR6390
Time Frame
Cycle 1 Day 14, Day 15, each cycle is 28 days
Title
Objective Response Rate (ORR)
Time Frame
baseline to the date of first documentation of progression, assessed approximately up to 6 months after the last entered participant
Title
Duration of Response (DoR)
Time Frame
baseline to the date of first documentation of progression, assessed approximately up to 6 months after the last entered participant
Title
Progression Free Survival (PFS)
Time Frame
baseline to the date of first documentation of progression, assessed approximately up to 6 months after the last entered participant
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:
Histological diagnosis of metastatic or locally advanced breast cancer; Histologically proven diagnosis of ER-positive, HER2-negative;
At least 1 line of endocrine therapy in the metastatic or advanced setting that had progressed or intolerance; ≤ 2 lines of chemotherapy for metastatic or advanced disease;
Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1;
Expected survival of more than 3 months.
Exclusion Criteria:
All patients in monotherapy and or in combination wih phase who are known allergic to HRS8807 or SHR6390 ingredient;
Presence of symptomatic metastatic visceral disease ;
Patients with known active brain metastases;
Clinically serious cardiovascular disease;
Abnormal electrocardiographic (ECG) with clinical significancy by investigator judgement;
Abnormal thyroid function laboratory results;
Active infection or unexplained fever >38.5℃ during screening period or on the day of the first dose.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wenjie Xin
Phone
+0518-81220121
Email
Wenjie.xin@hengrui.com
Facility Information:
Facility Name
Fudan University Shanghai Cancer Center
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jiong Wu, Doctor
Phone
021-64175590
Email
wujiong1122@vip.sina.com
First Name & Middle Initial & Last Name & Degree
Jian Zhang
Phone
021-64175590
Email
syner2000@163.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
A Phase 1 Study of HRS8807 Monotherapy and in Combination With SHR6390 in Subjects With ER-Positive, HER2-Negative Metastatic or Locally Advanced Breast Cancer
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