Back to resultsTo Evaluate a Phase Ia/Ib Clinical Study of EG017 in Patients With Advanced Breast Cancer.
Primary Purpose
Breast Cancer
Status
Recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
EG017
Sponsored by
About this trial
This is an interventional treatment trial for Breast Cancer
Eligibility Criteria
Inclusion Criteria: Female, 18-75 years old; Expected survival ≥ 12 weeks; Subjects with ECOG score of physical state 0~1; Histologically confirmed recurrent or metastatic advanced breast cancer; Exclusion Criteria: Those who have had a severe allergic reaction to any drug or its components in this study in the past; Present with primary central nervous system (CNS) malignancies; Subjects with CNS metastasis who have failed local treatment (except asymptomatic BMS, or symptomatic BMS with complete remission of symptoms ≥ 2 weeks after treatment for BMS); Has any disease or syndrome that requires or is likely to require systemic steroid therapy during the study period; Gastrointestinal disorders or gastrointestinal diseases will significantly affect the absorption of test drugs (such as ulcerative disease, uncontrolled vomiting, diarrhea, malabsorption syndrome, biliary drainage status, etc.), or subjects cannot take drugs orally:
Sites / Locations
- Cancer Hospital of CAMSRecruiting
- First Affiliated Hospital of Zhengzhou UniversityRecruiting
- Henan Cancer HospitalRecruiting
- Wuhan Union HospitalRecruiting
- Hunan Cancer HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
EG017
Arm Description
70 subjects: Part Ia 10 subjects: A total of 3 dose groups of 6 mg/day, 18 mg/day, 24 mg/day are planned. Once a day, each treatment cycle was administered for 28 days. Part Ib 60 subjects: A total of 2 dose groups of 18 mg/day, 24 or 12mg/day are planned. Once a day, each treatment cycle was administered for 28 days.
Outcomes
Primary Outcome Measures
Safety and Tolerability of EG017 as Measured by the Number of Participants Experiencing Dose-limiting Toxicities (DLTs), Adverse Events (AEs), and Serious Adverse Events (SAEs).
The CTCAE criteria will be used to assess adverse events on this trial.
The effectiveness of EG017 in humans was evaluated by clinical benefit rate
The number and proportion of subjects in clinical remission at 24 weeks after administration were calculated
Secondary Outcome Measures
Full Information
NCT ID
NCT05673694
First Posted
December 30, 2022
Last Updated
August 6, 2023
Sponsor
Changchun GeneScience Pharmaceutical Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT05673694
Brief Title
To Evaluate a Phase Ia/Ib Clinical Study of EG017 in Patients With Advanced Breast Cancer.
Official Title
A Phase Ia/Ib Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of EG017 in Androgen Receptor-positive, Estrogen Receptor-positive, and Human Epidermal Growth Factor Receptor-2-negative Patients With Advanced Breast Cancer.
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 8, 2023 (Actual)
Primary Completion Date
November 7, 2025 (Anticipated)
Study Completion Date
January 2, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Changchun GeneScience Pharmaceutical Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
To evaluate the safety, tolerability, pharmacokinetics and efficacy of EG017 in androgen receptor-positive, estrogen receptor-positive, and human epidermal growth factor receptor-2-negative patients with advanced breast cancer.
Detailed Description
The major aims of the study are to define the safety profile of this new drug, and to determine a recommended.
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
Masking
None (Open Label)
Allocation
N/A
Enrollment
70 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
EG017
Arm Type
Experimental
Arm Description
70 subjects: Part Ia 10 subjects: A total of 3 dose groups of 6 mg/day, 18 mg/day, 24 mg/day are planned. Once a day, each treatment cycle was administered for 28 days.
Part Ib 60 subjects: A total of 2 dose groups of 18 mg/day, 24 or 12mg/day are planned. Once a day, each treatment cycle was administered for 28 days.
Intervention Type
Drug
Intervention Name(s)
EG017
Intervention Description
According to the dosage group of the program, once a day.
Primary Outcome Measure Information:
Title
Safety and Tolerability of EG017 as Measured by the Number of Participants Experiencing Dose-limiting Toxicities (DLTs), Adverse Events (AEs), and Serious Adverse Events (SAEs).
Description
The CTCAE criteria will be used to assess adverse events on this trial.
Time Frame
28 Days
Title
The effectiveness of EG017 in humans was evaluated by clinical benefit rate
Description
The number and proportion of subjects in clinical remission at 24 weeks after administration were calculated
Time Frame
24 Weeks
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
postmenopausal women or women in a postmenopausal state
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Female, 18-75 years old;
Expected survival ≥ 12 weeks;
Subjects with ECOG score of physical state 0~1;
Histologically confirmed recurrent or metastatic advanced breast cancer;
Exclusion Criteria:
Those who have had a severe allergic reaction to any drug or its components in this study in the past;
Present with primary central nervous system (CNS) malignancies; Subjects with CNS metastasis who have failed local treatment (except asymptomatic BMS, or symptomatic BMS with complete remission of symptoms ≥ 2 weeks after treatment for BMS);
Has any disease or syndrome that requires or is likely to require systemic steroid therapy during the study period;
Gastrointestinal disorders or gastrointestinal diseases will significantly affect the absorption of test drugs (such as ulcerative disease, uncontrolled vomiting, diarrhea, malabsorption syndrome, biliary drainage status, etc.), or subjects cannot take drugs orally:
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lijun Tang
Phone
+86 18570616501
Email
tanglijun@gensci-china.com
Facility Information:
Facility Name
Cancer Hospital of CAMS
City
Beijing
State/Province
Benjing
ZIP/Postal Code
100020
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Binghe Xu, Doctor
Phone
+86-10-87788826
Email
xubinghe@medmail.com.cn
Facility Name
First Affiliated Hospital of Zhengzhou University
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450000
Country
China
Individual Site Status
Recruiting
Facility Name
Henan Cancer Hospital
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450000
Country
China
Individual Site Status
Recruiting
Facility Name
Wuhan Union Hospital
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430000
Country
China
Individual Site Status
Recruiting
Facility Name
Hunan Cancer Hospital
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410000
Country
China
Individual Site Status
Recruiting
12. IPD Sharing Statement
Learn more about this trial
To Evaluate a Phase Ia/Ib Clinical Study of EG017 in Patients With Advanced Breast Cancer.
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