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

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

Recruiting
18-80 years
Female
Phase 1

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Overview

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.

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

Study details
    Breast Cancer

NCT05673694

Changchun GeneScience Pharmaceutical Co., Ltd.

25 January 2024

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A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

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