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.
Status: Recruiting
Location: See all (5) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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.
Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:
• 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;
Locations
Other Locations
China
Cancer Hospital of CAMS
RECRUITING
Beijing
Hunan Cancer Hospital
RECRUITING
Changsha
Wuhan Union Hospital
RECRUITING
Wuhan
First Affiliated Hospital of Zhengzhou University
RECRUITING
Zhengzhou
Henan Cancer Hospital
RECRUITING
Zhengzhou
Contact Information
Primary
Wei Wang
wangwei13@genscigroup.com
+86 18201085833
Time Frame
Start Date: 2023-03-08
Estimated Completion Date: 2026-01-02
Participants
Target number of participants: 70
Treatments
Experimental: EG017
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.
Related Therapeutic Areas
Sponsors
Leads: Changchun GeneScience Pharmaceutical Co., Ltd.