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

Last updated: December 12, 2023
Sponsor: Changchun GeneScience Pharmaceutical Co., Ltd.
Overall Status: Active - Recruiting

Phase

1

Condition

Breast Cancer

Cancer

Treatment

EG017

Clinical Study ID

NCT05673694
EG017
  • Ages 18-80
  • Female

Study 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 Criteria

Inclusion

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

Exclusion Criteria:

  1. Those who have had a severe allergic reaction to any drug or its components in thisstudy in the past;
  2. Present with primary central nervous system (CNS) malignancies; Subjects with CNSmetastasis who have failed local treatment (except asymptomatic BMS, or symptomaticBMS 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 steroidtherapy during the study period;
  4. Gastrointestinal disorders or gastrointestinal diseases will significantly affect theabsorption of test drugs (such as ulcerative disease, uncontrolled vomiting, diarrhea,malabsorption syndrome, biliary drainage status, etc.), or subjects cannot take drugsorally:

Study Design

Total Participants: 70
Treatment Group(s): 1
Primary Treatment: EG017
Phase: 1
Study Start date:
March 08, 2023
Estimated Completion Date:
January 02, 2026

Study Description

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

Connect with a study center

  • Cancer Hospital of CAMS

    Beijing, Benjing 100020
    China

    Active - Recruiting

  • First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan 450000
    China

    Active - Recruiting

  • Henan Cancer Hospital

    Zhengzhou, Henan 450000
    China

    Active - Recruiting

  • Wuhan Union Hospital

    Wuhan, Hubei 430000
    China

    Active - Recruiting

  • Hunan Cancer Hospital

    Changsha, Hunan 410000
    China

    Active - Recruiting

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