Evaluating a new drug for advanced breast cancer
A Phase Ia/Ib Clinical Study 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.
This study is testing a new drug called EG017 to see if it is safe and effective for women with advanced breast cancer that has certain hormone receptors.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | Female |
| Sponsor | Changchun GeneScience Pharmaceutical Co., Ltd. Industry-sponsored |
| Locations | 5 sites (Beijing, Benjing and 4 other locations) |
| Trial ID | NCT05673694 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to assess the safety, tolerability, pharmacokinetics, and efficacy of a new drug called EG017 in patients with advanced breast cancer who are positive for androgen receptors and estrogen receptors, and negative for human epidermal growth factor receptor-2. The study will involve female participants aged 18 to 75 years with a confirmed diagnosis of recurrent or metastatic breast cancer. Researchers will monitor participants for adverse effects and determine the recommended dosage of EG017 based on the findings.
Who should consider this trial
Good fit: Ideal candidates for this study are females aged 18-75 with advanced breast cancer that is androgen receptor-positive and estrogen receptor-positive.
Not a fit: Patients with primary central nervous system malignancies or those who have had severe allergic reactions to the study drug will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new treatment option for patients with advanced breast cancer.
How similar studies have performed: While this approach is novel, similar studies targeting advanced breast cancer have shown promise in evaluating new treatments.
Eligibility criteria
Show full inclusion / exclusion criteria
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:
Where this trial is running
Beijing, Benjing and 4 other locations
- Cancer Hospital of CAMS — Beijing, Benjing, China (Recruiting)
- First Affiliated Hospital of Zhengzhou University — Zhengzhou, Henan, China (Recruiting)
- Henan Cancer Hospital — Zhengzhou, Henan, China (Recruiting)
- Wuhan Union Hospital — Wuhan, Hubei, China (Recruiting)
- Hunan Cancer Hospital — Changsha, Hunan, China (Recruiting)
Study contacts
- Study coordinator: Wei Wang
- Email: wangwei13@genscigroup.com
- Phone: +86 18201085833
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.