To Evaluate a Phase Ia/Ib Clinical Study of EG017 in Patients With Advanced Breast Cancer.

Breast Cancer Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05673694
• Other study ID #: EG017
• Status: Recruiting
• Phase: Phase 1
• Start date: March 8, 2023
• Est. completion date: January 2, 2026

Study information

• Verified date: December 2023
• Source: Changchun GeneScience Pharmaceutical Co., Ltd.
• Contact: Wei Wang
• Phone: +86 18201085833
• Email: wangwei13[@]genscigroup.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

The major aims of the study are to define the safety profile of this new drug, and to determine a recommended.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: January 2, 2026
• Est. primary completion date: November 7, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Female, 18-75 years old;

2. Expected survival = 12 weeks;

3. Subjects with ECOG score of physical state 0~1;

4. Histologically confirmed recurrent or metastatic advanced breast cancer;

Exclusion Criteria:

1. Those who have had a severe allergic reaction to any drug or its components in this study in the past;

2. 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);

3. Has any disease or syndrome that requires or is likely to require systemic steroid therapy during the study period;

4. 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:

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• EG017
According to the dosage group of the program, once a day.

Locations

Country	Name	City	State
China	Cancer Hospital of CAMS	Beijing	Benjing
China	Hunan Cancer Hospital	Changsha	Hunan
China	Wuhan Union Hospital	Wuhan	Hubei
China	First Affiliated Hospital of Zhengzhou University	Zhengzhou	Henan
China	Henan Cancer Hospital	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Changchun GeneScience Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	28 Days
Primary	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	24 Weeks