Neoplasms

Digestive System Diseases

All Conditions

Skin and Connective Tissue Diseases

Respiratory Tract (Lung and Bronchial) Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Rare Diseases

Stomach Neoplasms

Breast Neoplasms

Colorectal Neoplasms

Lung Neoplasms

Ovarian Neoplasms

Urinary Bladder Neoplasms

Breast Diseases

Skin Diseases

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Endocrine System Diseases

Gonadal Disorders

Stomach Diseases

Urologic Neoplasms

Urinary Bladder Diseases

Urologic Diseases

Male Urogenital Diseases

Stomach Cancer

Ovarian Cancer

Administered via intravenous (IV) infusion

ESG401

Xiaoyan Xing, PhD

Fei Ma

The primary objective in Phase I is to evaluate the safety and tolerability of ESG401 as a single agent administered in 21-day treatment cycles in previously treated participants with advanced epithelial cancer. In Phase II, the primary objective is to evaluate the safety and efficacy of ESG401 administered in 21-day treatment cycles at a dose selected in Phase I.

Tumor types in the study will include: cervical, colorectal, endometrial, ovarian, esophageal, gastric adenocarcinoma, glioblastoma multiforme, head and neck cancers- squamous cell, hepatocellular, prostate, non-small-cell lung cancer, pancreatic, renal cell, small-cell lung cancer, non-triple negative breast cancer (non-TNBC), triple-negative breast cancer (TNBC) and metastatic urothelial cancer (mUC).

Study of ESG401 in Adults With Solid Tumors

An Open-Label, Multiple Dose, Dose Escalation and Cohort Expansion Phase I/II Study to Investigate the Safety, Tolerability, Pharmacokinetics and Antitumor Activities of ESG401 in Subjects With Locally Advanced/Metastatic Solid Tumors

Treatment-emergent adverse events (TEAEs) were defined as any adverse events (AEs) that begin or worsen on or after the start of study drug through 30 days after the last dose of study drug. The severity was graded based on the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 5.0. An AE that met one or more of the following outcomes was classified as serious:

Fatal Life-threatening Disabling/incapacitating Results in hospitalization or prolongs a hospital stay A congenital abnormality Other important medical events may also be considered serious AEs if they may require medical or surgical intervention to prevent one of the outcomes listed above

ORR is defined as the rate an overall best response of either complete response (CR) or partial response (PR) by ICR assessment according to RECIST1.1. CR was defined as the disappearance of all target lesions and reduction in short axis of any pathologic lymphnode to \<10 mm. PR was defined as ≥ 30% decrease in the sum of diameters of target lesions, taking the baseline sum diameters. Per planned analysis, ORR by ICR will be assessed for the TNBC Target Population in phase 2 only.

Area under the serum concentration time curve from time 0 extrapolated to infinity

ORR is defined as the rate an overall best response of either complete response (CR) or partial response (PR) by local assessment. CR was defined as the disappearance of all target lesions and reduction in short axis of any pathologic lymphnode to \<10 mm. PR was defined as ≥3 0% decrease in the sum of diameters of target lesions, taking the baseline sum diameters. Per planned analysis, ORR by local assessment will be assessed for the Target Population both in phase 1 and phase 2.

Progression-free survival (PFS) is defined as the interval from the first dose start date to the date of disease progression defined as documented progressive disease (PD) or death from any cause, whichever occurs first.

Overall survival is defined as the time from the date of the first dose start date to the date of death due to any cause.

Shanghai Escugen Biotechnology Co., Ltd

Antineoplastic Agents

All Drugs and Chemicals

Gemcitabine

Capecitabine

Vinorelbine

Antimetabolites

Tubulin Modulators

Antimitotic Agents

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

Eribulin 1.4 mg/m2, IV infusion on day 1 and 8 of each 21 day cycle

Capecitabine 1000 or 1250 mg/m2, po, from day 1 to 14 of each 21 day cycle

Vinorelbine 25 mg/m2, IV infusion on day 1 and 8 of each 21 day cycle

Gemcitabine 1000 mg/m2, IV infusion on day 1,8 and 15 of each 28day cycle

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

Eribulin, capecitabine, gemcitabine or vinorelbine

Eribulin, capecitabine, gemcitabine or vinorelbine (Treatment of Physician's Choice)

Fei Ma, PhD

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.

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.

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

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

PFS was defined as the time from randomization to PD or death, whichever occurs first.

OS was defined as the time from randomization to death.

ORR was defined as the proportion of of patients with a CR and PR assessed by IRC and investigators per RECIST v 1.1

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

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.

To assess the impact of ESG401 on disease related symptoms and quality of life of patients using the NCC-BC-A scale

Incidence and severity of AEs and SAEs (per CTCAE 5.0), and clinically significant abnormal laboratory findings

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.

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.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Study of ESG401 in Adults With Solid Tumors	NCT04892342	Neoplasms, Brea... Neoplasms, Lung Neoplasms,Color... Neoplasms, Blad... Neoplasm of Sto... Neoplasms,Ovari...	ESG401	18 Years - 75 Years	Shanghai Escugen Biotechnology Co., Ltd
A Phase III Study of ESG401 for Locally Advanced or Metastatic HR+/HER2- Breast Cancer	NCT06383767	Metastatic Brea...	ESG401 Eribulin, capec...	18 Years -	Shanghai Escugen Biotechnology Co., Ltd
A Phase III Study of ESG401 for Locally Advanced or Metastatic HR+/HER2- Breast Cancer	NCT06383767	Metastatic Brea...	ESG401 Eribulin, capec...	18 Years -	Shanghai Escugen Biotechnology Co., Ltd

Spots Global Cancer Trial Database for esg401

Every month we try and update this database with for esg401 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for esg401

Every month we try and update this database with for esg401 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for esg401 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.