A Phase III Study of ESG401 for Unresectable Recurrent or Metastatic Triple-Negative Breast Cancer

NCT ID: NCT06732323

Last Updated: 2025-09-23

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 504 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-04
• Study Completion Date: 2028-07-31

Brief Summary

The aim of this study is to evaluate the efficacy and safety of ESG401 as first-line treatment in patients with unresectable recurrent or metastatic triple-negative breast cancer.

Detailed Description

This is a randomized, open-label, multicenter Phase 3 study to evaluate ESG401 versus Investigator's Choice Chemotherapy (ICC) as first-line treatment in subjects with unresectable recurrent or metastatic triple-negative breast cancer.

Conditions

Triple-Negative Breast Cancer (TNBC)

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

Investigator's Choice Chemotherapy

If no prior taxane, or prior taxane in the (neo)adjuvant setting and disease-free interval (DFI) \>12 months: paclitaxel or nab-paclitaxel. Note: If subjects are intolerant or contraindicated to receive paclitaxel or albumin-paclitaxel, the investigator may choose other chemotherapy options listed in the study protocol) If prior taxane and DFI ≤ 12 months: capecitabine, eribulin. If known BRCA1/2 mutation: carboplatin

Group Type: ACTIVE_COMPARATOR

Investigator's Choice Chemotherapy

Intervention Type: DRUG

Paclitaxel, Nab-paclitaxel, Capecitabine, Eribulin, or Carboplatin

Interventions

ESG401

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

Intervention Type: DRUG

Investigator's Choice Chemotherapy

Paclitaxel, Nab-paclitaxel, Capecitabine, Eribulin, or Carboplatin

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Males or females aged ≥ 18 years ;

2. Histologically and/or cytologically confirmed TNBC;

3. De novo metastatic or relapsed ≥ 6 months post completion of treatment with curative intent;

4. No prior systemic anti-cancer therapy for unresectable recurrent or metastatic disease;

5. Participants whose tumours are PD-L1-negative, or Participants whose tumours are PD-L1-positive and have relapsed after prior PD-1/PD-L1 inhibitor therapy for early-stage breast cancer, or comorbidities precluding PD-1/PD-L1 inhibitor therapy;

6. Eligible for the chemotherapy options listed as investigator's choice chemotherapy (paclitaxel, nab-paclitaxel, capecitabine, eribulin, or carboplatin) as assessed by the investigator;

7. At least one measurable lesion per RECIST v1.1;

8. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 with no worsening within 2 weeks prior to randomization;

9. A life expectancy of at least 12 weeks;

10. Adequate organ and bone marrow function.

Exclusion Criteria

1. Use of any investigational anti-cancer drug within 28 days or 5 half-lives before the first investigational product administration.

2. Toxicities from prior anti-tumor therapy not recovering to ≤ Grade 1.

3. Prior topoisomerase I inhibitor therapy, including antibody-drug conjugate(ADC) therapy, or prior TROP2 targeted therapy.

4. New thromboembolic events, intestinal obstruction, gastrointestinal bleeding or perforation within 6 months.

5. Subjects with symptomatic or untreated CNS metastases, or those requiring ongoing treatment for CNS metastases.

6. Patients with Primary CNS malignancy, or patients with other malignancies within 3 years prior to the first dose.

7. Patients with uncontrollable systemic diseases.

8. Patients with gastrointestinal diseases (such as chronic gastritis, chronic enteritis or gastric ulcers), or with a previous history of severe or chronic diarrhea.

9. Subjects with clinically significant cardiovascular disease.

10. Human Immunodeficiency Virus (HIV) infection.

11. Active hepatitis B or hepatitis C.

12. 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.

13. 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

Role: PRINCIPAL_INVESTIGATOR

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Locations

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Beijing, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Xiaoyan Xing, PhD

Role: CONTACT

xingxiaoyan@escugen.com

+86 21 5855 6098

Fei Ma, PhD

Role: CONTACT

Facility Contacts

Fei Ma, PhD

Role: primary

drmafei@126.com

8610-8778-8120

Other Identifiers

ESG401-302

Identifier Type: -

Identifier Source: org_study_id