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

Metastatic Breast Cancer Clinical Trial

Official title:

A Open-label, Randomized, Multicenter Phase III Study of ESG401 Versus Treatment of Physician's Choice in Patients With Locally Advanced or Metastatic HR+/HER2- Breast Cancer Who Had Failed at Least One Line of Chemotherapy

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06383767
• Other study ID #: ESG401-301
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: June 30, 2024
• Est. completion date: December 31, 2026

Study information

• Verified date: April 2024
• Source: Shanghai Escugen Biotechnology Co., Ltd
• Contact: Xiaoyan Xing, PhD
• Phone: +86 21 5855 6098
• Email: xingxiaoyan[@]escugen.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 378
• Est. completion date: December 31, 2026
• Est. primary completion date: July 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Neoplasms
• Metastatic Breast Cancer

Intervention

Drug:
• ESG401
IV infusion on day 1,8, and 15 of each 28 day cycle
• Eribulin, capecitabine, gemcitabine or vinorelbine (Treatment of Physician's Choice)
Eribulin, capecitabine, gemcitabine or vinorelbine

Locations

Country	Name	City	State
China	Cancer Hospital Chinese Academy of Medical Sciences	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Escugen Biotechnology Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival (PFS) assessed by IRC per RECIST 1.1	PFS was defined as the time from randomization to PD or death, whichever occurs first.	Up to 24 months
Secondary	Progression-free survival (PFS) assessed by the investigators per RECIST V 1.1	PFS was defined as the time from randomization to PD or death, whichever occurs first.	Up to 24 months
Secondary	Overall Survival (OS)	OS was defined as the time from randomization to death.	Up to 24 months
Secondary	Objective Response Rate (ORR)	ORR was defined as the proportion of of patients with a CR and PR assessed by IRC and investigators per RECIST v 1.1	Up to 24 months
Secondary	Clinical Benefit Rate (CBR)	CBR was defined as the proportion of patients with a CR or PR or with SD at Week 24 assessed by IRC and investigators per RECIST v 1.1	Up to 24 months
Secondary	Duration of Response (DoR)	From the date that response criteria are first met to the first occurrence of PD as determined by BIRC and investigators per RECIST v1.1 or death from any cause, whichever occurs first.	Up to 24 months
Secondary	Quality of life evaluated using the NCC-BC-A scale	To assess the impact of ESG401 on disease related symptoms and quality of life of patients using the NCC-BC-A scale	Up to 24 months
Secondary	Adverse events(AEs) and severe adverse events (SAEs)	Incidence and severity of AEs and SAEs (per CTCAE 5.0), and clinically significant abnormal laboratory findings	From signing the ICF up to last dose plus 30 days
Secondary	Clearance	Mean population clearance will be derived from pooled data of drug concentrations. Covariates of influence on drug clearance will be incorporated within a population pharmacokinetic model.	Up to 24 months
Secondary	Volume of distribution	Mean population volume of distribution will be derived from pooled data of drug concentrations. Covariates of influence on volume of distribution will be incorporated within a population pharmacokinetic model.	Up to 24 months
Secondary	ADA	Incidence of anti-drug antibodies	Up to 24 months