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

NCT05673694 | Unknown Phase 1

• 1 other identifier: EG017
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 5

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (2)

• 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).

  The CTCAE criteria will be used to assess adverse events on this trial.

  28 Days

• The effectiveness of EG017 in humans was evaluated by clinical benefit rate

  The number and proportion of subjects in clinical remission at 24 weeks after administration were calculated

  24 Weeks

Study Arms (1)

EG017

EXPERIMENTAL

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.

Drug: EG017

Interventions

EG017 DRUG

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

EG017

Eligibility Criteria

• Age: 18 Years - 80 Years
• Gender Eligibility Details: postmenopausal women or women in a postmenopausal state
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• Those who have had a severe allergic reaction to any drug or its components in this study in the past;
• 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);
• Has any disease or syndrome that requires or is likely to require systemic steroid therapy during the study period;
• 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:

Sponsors & Collaborators

• Changchun GeneScience Pharmaceutical Co., Ltd.: lead

Study Sites (5)

Cancer Hospital of CAMS

Beijing, Benjing, 100020, China

RECRUITING

First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, 450000, China

RECRUITING

Henan Cancer Hospital

Zhengzhou, Henan, 450000, China

RECRUITING

Wuhan Union Hospital

Wuhan, Hubei, 430000, China

RECRUITING

Hunan Cancer Hospital

Changsha, Hunan, 410000, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Wei Wang

CONTACT

+86 18201085833; wangwei13@genscigroup.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 30, 2022
• First Posted: January 6, 2023
• Study Start: March 8, 2023
• Primary Completion: November 7, 2025
• Study Completion: January 2, 2026
• Last Updated: December 14, 2023

Record last verified: 2023-12

Locations

CN (5)