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

Official title

A Randomized, Open-label, Phase III Study of ESG401 Versus Investigator's Choice Chemotherapy as First-line Treatment in Patients With Unresectable Recurrent or Metastatic Triple-Negative Breast Cancer

Overview

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.

Interventions

• Drug ESG401
  IV infusion on day 1,8, and 15 of each 28 day cycle
• Drug Investigator's Choice Chemotherapy
  Paclitaxel, Nab-paclitaxel, Capecitabine, Eribulin, or Carboplatin

Primary outcome measures

• Progression Free Survival (PFS) assessed by Blinded Independent Central Review (BICR) [Time frame: Randomization up to approximately 28 months]
• Overall Survival (OS) [Time frame: Randomization up to approximately 41 months]

Secondary outcome measures (12)

• Progression-Free Survival (PFS) assessed by Investigator [Time frame: Randomization up to approximately 28 months]
• Objective Response Rate (ORR) assessed by Blinded Independent Central Review (BICR) [Time frame: Randomization up to approximately 28 months]
• Disease control rate (DCR) assessed by Blinded Independent Central Review (BICR) [Time frame: Randomization up to approximately 28 months]
• Duration of Response (DoR) assessed by Blinded Independent Central Review (BICR) [Time frame: Randomization up to approximately 28 months]
• Time to Response (TTR) assessed by Blinded Independent Central Review (BICR) [Time frame: Randomization up to approximately 28 months]
• Objective Response Rate (ORR) assessed by Investigator [Time frame: Randomization up to approximately 28 months]
• Disease control rate (DCR) assessed by Investigator [Time frame: Randomization up to approximately 28 months]
• Duration of Response (DoR) assessed by Investigator [Time frame: Randomization up to approximately 28 months]
• Time to Response (TTR) assessed by Investigator [Time frame: Randomization up to approximately 28 months]
• Quality of life evaluated using the NCC-BC-A scale [Time frame: Randomization up to approximately 28 months]
• Adverse events(AEs) and severe adverse events (SAEs) [Time frame: From signing the ICF up to last dose plus 30 days]
• Clearance [Time frame: Randomization up to approximately 28 months]

Eligibility criteria

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

China · 1 center

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences — Beijing

Identifiers

NCT: NCT06732323 · ESG401-302

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗