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Trial Title:
A Phase III Study of ESG401 for Locally Advanced or Metastatic HR+/HER2- Breast Cancer
NCT ID:
NCT06383767
Condition:
Metastatic Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Gemcitabine
Capecitabine
Vinorelbine
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
ESG401
Description:
IV infusion on day 1,8, and 15 of each 28 day cycle
Arm group label:
ESG401 for injection
Intervention type:
Drug
Intervention name:
Eribulin, capecitabine, gemcitabine or vinorelbine (Treatment of Physician's Choice)
Description:
Eribulin, capecitabine, gemcitabine or vinorelbine
Arm group label:
Treatment of Physician's Choice
Summary:
The aim of this study is to evaluate the efficacy and safety of ESG401 in patients with
unresectable locally advanced or metastatic HR+/HER2- breast cancer.
Detailed description:
This is a open-label, randomized, multicenter Phase 3 study to evaluate ESG401 versus
Treatment of Physician's Choice (TPC) in subjects with unresectable locally advanced or
metastatic HR+/HER2- breast cancer who had failed at least one line of systemic
chemotherapy.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Individuals able to understand and give written informed consent.
- Males or females aged ≥ 18 years ;
- Histologically and/or cytologically confirmed HR+/HER2- breast cancer who had failed
at least one line of systemic chemotherapy in metastatic settings;
- Patients who are eligible for a chemotherapy regimen in the control group;
- Patients with at least one measurable lesion per RECIST 1.1 criteria;
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1;
- Expected survival ≥ 12 weeks;
- Patients with adequate organ and bone marrow function;
- Female patients of childbearing potential and male patients with partners of
childbearing potential who use effective medical contraception from the time of
signing the informed consent form until 180 days after the last dose.
Exclusion Criteria:
- Received chemotherapy, targeted therapy, immunotherapy, interventional therapy or
other systemic anti-cancer therapie within 4 weeks before the first investigational
product administration;
- Toxicities from prior anti-tumor therapy not recovering to ≤ Grade 1;
- Received major surgeries 4 weeks prior to the first dose of study treatment or
planned to receive major surgeries during the study ;
- Prior topoisomerase I inhibitor therapy, including antibody-drugconjugate(ADC)
therapy, or prior TROP2 targeted therapy, or use of any investigational anti-cancer
drug within 28 days or 5 half-lives before the first investigational product
administration;
- New thromboembolic events, intestinal obstruction, gastrointestinal bleeding or
perforation within 6 months;
- Uncontrolled systemic bacterial, viral or fungal infections;
- Subjects with symptomatic or untreated CNS metastases, or those requiring ongoing
treatment for CNS metastases;
- Patients with Primary CNS malignancy；or patients with other malignancies within 3
years prior to the first dose;
- Patients with uncontrollable systemic diseases;
- Patients with gastrointestinal diseases (such as chronic gastritis, chronic
enteritis or gastric ulcers), or with a previous history of severe or chronic
diarrhea;
- Subjects with clinically significant cardiovascular disease;
- Human Immunodeficiency Virus (HIV) infection;
- Active hepatitis B or hepatitis C;
- Known immediate or delayed hypersensitivity reaction to irinotecan or other
camptocampin derivatives such as topotecan or to have had grade ≥3 gastrointestinal
reactions associated with irinotecan, or allergies, or to any investigational drug
or excipient ingredient;
- Pregnant or lactating women.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Cancer Hospital Chinese Academy of Medical Sciences
Address:
City:
Beijing
Zip:
100021
Country:
China
Status:
Recruiting
Contact:
Last name:
Fei Ma, PhD
Start date:
July 11, 2024
Completion date:
December 31, 2026
Lead sponsor:
Agency:
Shanghai Escugen Biotechnology Co., Ltd
Agency class:
Industry
Source:
Shanghai Escugen Biotechnology Co., Ltd
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06383767
