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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-08

Study Completion Date

2026-01-02

Brief Summary

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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.

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Detailed Description

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

Conditions

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Breast Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

EG017

Intervention Type DRUG

According to the dosage group of the program, once a day.

Interventions

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EG017

According to the dosage group of the program, once a day.

Intervention Type DRUG

Eligibility Criteria

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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:

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No