NCT06732323 A Phase III Study of ESG401 for Unresectable Recurrent or Metastatic Triple-Negative Breast Cancer

Eligibility & Interventions

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.

This trial targets 504 participants in total. It began in 2025-09-04 with a primary completion date of 2027-06.

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.

Eligibility Criteria

Key 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. Key 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.

Contact & Investigator

Frequently Asked Questions

Related Trials

Related Intelligence Guides

In-depth guides covering this condition's trials, eligibility, and what to expect.