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

Phase 1

Recruiting

• Conditions: Breast Cancer
• Interventions: Drug: EG017

• Registration Number: NCT05673694
• Lead Sponsor: Changchun GeneScience Pharmaceutical Co., Ltd.

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.

Study Timeline

• Study First Submitted: 2022-12-30
• Study First Submitted QC: 2022-12-30
• Study First Posted: 2023-01-06
• Study Start: 2023-03-08
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-12
• Last Update Posted: 2023-12-14
• Primary Completion: 2025-11-07
• Study Completion: 2026-01-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 70

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:

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
EG017	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.

Primary Outcome Measures

Name	Time	Method
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).	28 Days	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	24 Weeks	The number and proportion of subjects in clinical remission at 24 weeks after administration were calculated

Trial Locations

Locations (5)

First Affiliated Hospital of Zhengzhou University; 🇨🇳 Zhengzhou, Henan, China

Cancer Hospital of CAMS; 🇨🇳 Beijing, Benjing, China

Henan Cancer Hospital; 🇨🇳 Zhengzhou, Henan, China

Wuhan Union Hospital; 🇨🇳 Wuhan, Hubei, China

Hunan Cancer Hospital; 🇨🇳 Changsha, Hunan, China