Back to resultsA Trial of HRS-1358 Tablets in Metastatic or Local Advanced Breast Cancer
Primary Purpose
Breast Cancer
Status
Enrolling by invitation
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
HRS-1358
Sponsored by
About this trial
This is an interventional treatment trial for Breast Cancer
Eligibility Criteria
Inclusion Criteria: Histologically diagnosis of local advanced or metastatic breast cancer Women must be postmenopausal, or pre-/peri-menopausal women must be on ovarian suppression At least 1 line of endocrine therapy in the metastatic or advanced setting ECOG performance status score: 0-1; Adequate organ functions as defined Ability to understand and voluntarily agrees to participate by giving written informed consent for the study. Exclusion Criteria: the investigators judged that it was not suitable to endocrine therapy patients with active brain metastasis (without medical control or with clinical symptoms), History of clinically significant cardiovascular or cerebrovascular diseases The subject has one of many factors affecting oral 、absorption, distribution, metabolism and excretion of drugs Active autoimmune diseases, History of immunodeficiency, including positive HIV serum test result and other acquired or congenital immunodeficiency diseases, or history of organ transplantation Have received other similar drugs in the past; Known history of allergy to HRS-1358 ingredients
Sites / Locations
- Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
HRS-1358
Arm Description
Daily oral dosages of HR-1358
Outcomes
Primary Outcome Measures
Dose Limited Toxicities (DLTs)
Number of participants with dose-limiting toxicities (DLTs)
Maximum tolerated dose
The Maximum tolerated dose of HRS-1358 monotherapy
RP2D
select the Recommended Phase 2 Dose (RP2D) of HRS-1358
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-1358 monotherapy
Tmax
PK parameters of multiple doses of HRS-1358 monotherapy
AUC0-t
PK parameters of multiple doses of HRS-1358 monotherapy
Cmax,ss
PK parameters of multiple doses of HRS-1358 monotherapy
Tmax,ss
PK parameters of multiple doses of HRS-1358 monotherapy
Cmin,ss
PK parameters of multiple doses of HRS-1358 monotherapy
AUCss
PK parameters of multiple doses of HRS-1358 monotherapy
Rac
PK parameters of multiple doses of HRS-1358 monotherapy
Overall response rate (ORR) in participants
Clinical benefit rate (CBR) in participants
Duration of response (DOR) in participants
Progression Free Survival (PFS) observed in participants
Full Information
NCT ID
NCT05628870
First Posted
November 17, 2022
Last Updated
February 27, 2023
Sponsor
Shandong Suncadia Medicine Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT05628870
Brief Title
A Trial of HRS-1358 Tablets in Metastatic or Local Advanced Breast Cancer
Official Title
A Single-arm, Open-label, Multi-center Phase I Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of HRS-1358 Monotherapy in Patients With Metastatic or Locally Advanced Breast Cancer.
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
February 7, 2023 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
June 30, 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 safety and tolerability of HRS-1358 monotherapy in patients 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
Breast Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Model Description
Single arm study of HRS-1358
Masking
None (Open Label)
Allocation
N/A
Enrollment
102 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
HRS-1358
Arm Type
Experimental
Arm Description
Daily oral dosages of HR-1358
Intervention Type
Drug
Intervention Name(s)
HRS-1358
Intervention Description
HRS-1358 will be administered daily orally in continuous dosing over 28-day cycles.
Primary Outcome Measure Information:
Title
Dose Limited Toxicities (DLTs)
Description
Number of participants with dose-limiting toxicities (DLTs)
Time Frame
up to 28 days
Title
Maximum tolerated dose
Description
The Maximum tolerated dose of HRS-1358 monotherapy
Time Frame
up to 28 days
Title
RP2D
Description
select the Recommended Phase 2 Dose (RP2D) of HRS-1358
Time Frame
Change From Baseline at 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-1358 monotherapy
Time Frame
0.5 hour before first dose of first treatment period to the 0.5 hour before first dose of fourth treatment period
Title
Tmax
Description
PK parameters of multiple doses of HRS-1358 monotherapy
Time Frame
0.5 hour before first dose of first treatment period to the 0.5 hour before first dose of fourth treatment period
Title
AUC0-t
Description
PK parameters of multiple doses of HRS-1358 monotherapy
Time Frame
0.5 hour before first dose of first treatment period to the 0.5 hour before first dose of fourth treatment period
Title
Cmax,ss
Description
PK parameters of multiple doses of HRS-1358 monotherapy
Time Frame
0.5 hour before first dose of first treatment period to the 0.5 hour before first dose of fourth treatment period
Title
Tmax,ss
Description
PK parameters of multiple doses of HRS-1358 monotherapy
Time Frame
0.5 hour before first dose of first treatment period to the 0.5 hour before first dose of fourth treatment period
Title
Cmin,ss
Description
PK parameters of multiple doses of HRS-1358 monotherapy
Time Frame
0.5 hour before first dose of first treatment period to the 0.5 hour before first dose of fourth treatment period
Title
AUCss
Description
PK parameters of multiple doses of HRS-1358 monotherapy
Time Frame
0.5 hour before first dose of first treatment period to the 0.5 hour before first dose of fourth treatment period
Title
Rac
Description
PK parameters of multiple doses of HRS-1358 monotherapy
Time Frame
0.5 hour before first dose of first treatment period to the 0.5 hour before first dose of fourth treatment period
Title
Overall response rate (ORR) in participants
Time Frame
Up to approximately 1 year
Title
Clinical benefit rate (CBR) in participants
Time Frame
Up to approximately 1 year
Title
Duration of response (DOR) in participants
Time Frame
Up to approximately 1 year
Title
Progression Free Survival (PFS) observed in participants
Time Frame
Up to approximately 1 year
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:
Histologically diagnosis of local advanced or metastatic breast cancer
Women must be postmenopausal, or pre-/peri-menopausal women must be on ovarian suppression
At least 1 line of endocrine therapy in the metastatic or advanced setting
ECOG performance status score: 0-1;
Adequate organ functions as defined
Ability to understand and voluntarily agrees to participate by giving written informed consent for the study.
Exclusion Criteria:
the investigators judged that it was not suitable to endocrine therapy
patients with active brain metastasis (without medical control or with clinical symptoms),
History of clinically significant cardiovascular or cerebrovascular diseases
The subject has one of many factors affecting oral 、absorption, distribution, metabolism and excretion of drugs
Active autoimmune diseases, History of immunodeficiency, including positive HIV serum test result and other acquired or congenital immunodeficiency diseases, or history of organ transplantation
Have received other similar drugs in the past;
Known history of allergy to HRS-1358 ingredients
Facility Information:
Facility Name
Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100021
Country
China
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
A Trial of HRS-1358 Tablets in Metastatic or Local Advanced Breast Cancer
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