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

NCT06732323 | Recruiting Phase 3

• 1 other identifier: ESG401-302
• Study Type: interventional
• Target: 504
• Locations: 1 country
• Sites: 1

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.

Conditions

Triple-Negative Breast Cancer (TNBC)

Outcome Measures

Primary Outcomes (2)

• Progression Free Survival (PFS) assessed by Blinded Independent Central Review (BICR)

  Defined as the time from randomization to the first documented disease progression per RECIST 1.1 based on BICR or death due to any cause, whichever occurs first.

  Randomization up to approximately 28 months

• Overall Survival (OS)

  Defined as the time from randomization until the date of death due to any cause.

  Randomization up to approximately 41 months

Secondary Outcomes (14)

• Progression-Free Survival (PFS) assessed by Investigator

  Randomization up to approximately 28 months

• Objective Response Rate (ORR) assessed by Blinded Independent Central Review (BICR)

  Randomization up to approximately 28 months

• Disease control rate (DCR) assessed by Blinded Independent Central Review (BICR)

  Randomization up to approximately 28 months

• Duration of Response (DoR) assessed by Blinded Independent Central Review (BICR)

  Randomization up to approximately 28 months

• Time to Response (TTR) assessed by Blinded Independent Central Review (BICR)

  Randomization up to approximately 28 months

Study Arms (2)

ESG401 for injection

EXPERIMENTAL

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

Drug: ESG401

Investigator's Choice Chemotherapy

ACTIVE COMPARATOR

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

Drug: Investigator's Choice Chemotherapy

Interventions

ESG401 DRUG

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

ESG401 for injection

Investigator's Choice Chemotherapy DRUG

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

Investigator's Choice Chemotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males or females aged ≥ 18 years ;
• Histologically and/or cytologically confirmed TNBC;
• De novo metastatic or relapsed ≥ 6 months post completion of treatment with curative intent;
• No prior systemic anti-cancer therapy for unresectable recurrent or metastatic disease;
• 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;
• Eligible for the chemotherapy options listed as investigator's choice chemotherapy (paclitaxel, nab-paclitaxel, capecitabine, eribulin, or carboplatin) as assessed by the investigator;
• At least one measurable lesion per RECIST v1.1;
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 with no worsening within 2 weeks prior to randomization;
• A life expectancy of at least 12 weeks;
• Adequate organ and bone marrow function.

You may not qualify if:

• Use of any investigational anti-cancer drug within 28 days or 5 half-lives before the first investigational product administration.
• Toxicities from prior anti-tumor therapy not recovering to ≤ Grade 1.
• Prior topoisomerase I inhibitor therapy, including antibody-drug conjugate(ADC) therapy, or prior TROP2 targeted therapy.
• New thromboembolic events, intestinal obstruction, gastrointestinal bleeding or perforation within 6 months.
• 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.

Sponsors & Collaborators

• Qilu Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Beijing, China

RECRUITING

MeSH Terms

Conditions

Triple Negative Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Fei Ma

  Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaoyan Xing, PhD

CONTACT

+86 21 5855 6098; xingxiaoyan@escugen.com

Fei Ma, PhD

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2024
• First Posted: December 13, 2024
• Study Start: September 4, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): July 1, 2028
• Last Updated: September 23, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)