A Phase III Study of ESG401 for Locally Advanced or Metastatic HR+/HER2- Breast Cancer

NCT ID: NCT06383767

Last Updated: 2025-06-19

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 378 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-11
• Study Completion Date: 2028-07-31

Brief 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.

Conditions

Metastatic Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ESG401 for injection

IV infusion on day 1, 8 and15 of each 28 day cycle

Group Type: EXPERIMENTAL

ESG401

Intervention Type: DRUG

IV infusion on day 1,8, and 15 of each 28 day cycle

Treatment of Physician's Choice

Eribulin 1.4 mg/m2, IV infusion on day 1 and 8 of each 21 day cycle

Capecitabine 1000 or 1250 mg/m2, po, from day 1 to 14 of each 21 day cycle

Vinorelbine 25 mg/m2, IV infusion on day 1 and 8 of each 21 day cycle

Gemcitabine 1000 mg/m2, IV infusion on day 1,8 and 15 of each 28day cycle

Group Type: ACTIVE_COMPARATOR

Eribulin, capecitabine, gemcitabine or vinorelbine (Treatment of Physician's Choice)

Intervention Type: DRUG

Eribulin, capecitabine, gemcitabine or vinorelbine

Interventions

ESG401

IV infusion on day 1,8, and 15 of each 28 day cycle

Intervention Type: DRUG

Eribulin, capecitabine, gemcitabine or vinorelbine (Treatment of Physician's Choice)

Eribulin, capecitabine, gemcitabine or vinorelbine

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Qilu Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Fei Ma, PhD

Role: PRINCIPAL_INVESTIGATOR

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Locations

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Yong Yuan, Master Degree

Role: CONTACT

yong3.yuan@qilu-pharma.com

+86 13820384005

Facility Contacts

Fei Ma, PhD

Role: primary

Other Identifiers

ESG401-301

Identifier Type: -

Identifier Source: org_study_id