Study of ESG401 in Adults With Solid Tumors

NCT04892342 | Completed Phase 1

• 1 other identifier: ESG401-101
• Study Type: interventional
• Target: 156
• Locations: 1 country
• Sites: 3

Brief Summary

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).

Conditions

Neoplasms, Breast; Neoplasms, Lung; Neoplasms,Colorectal; Neoplasms, Bladder; Neoplasm of Stomach; Neoplasms,Ovarian

Outcome Measures

Primary Outcomes (2)

• Percentage of Participants Experiencing Any Treatment Emergent Adverse Events and Serious Treatment Emergent Adverse Events

  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

  First dose date up to last dose plus 30 days

• Objective Response Rate (ORR) by Independent Central Review (ICR)

  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.

  Up to 49 months

Secondary Outcomes (6)

• Cmax

  Up to 49 months

• AUC0-inf

  Up to 49 months

• Objective Response Rate by Local Assessment

  Up to 49 months

• Progression Free Survival (PFS) by Local Assessment

  Up to 49 months

• Overall Survival by Local Assessment

  Up to 49 months

Study Arms (10)

ESG401 dose level 1

EXPERIMENTAL

Drug: ESG401

ESG401 dose level 2

EXPERIMENTAL

Drug: ESG401

ESG401 dose level 3

EXPERIMENTAL

Drug: ESG401

ESG401 dose level 4

EXPERIMENTAL

Drug: ESG401

ESG401 dose level 5

EXPERIMENTAL

Drug: ESG401

ESG401 dose level 6

EXPERIMENTAL

Drug: ESG401

ESG401 dose level 7

EXPERIMENTAL

Drug: ESG401

ESG401 dose level 8

EXPERIMENTAL

Drug: ESG401

ESG401 dose level 9

EXPERIMENTAL

Drug: ESG401

ESG401 dose level 10

EXPERIMENTAL

Drug: ESG401

Interventions

ESG401 DRUG

Administered via intravenous (IV) infusion

ESG401 dose level 1; ESG401 dose level 10; ESG401 dose level 2; ESG401 dose level 3; ESG401 dose level 4; ESG401 dose level 5; ESG401 dose level 6; ESG401 dose level 7; ESG401 dose level 8; ESG401 dose level 9

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individuals able to understand and give written informed consent.
• Subjects must have a histologically or cytologically confirmed advanced or metastatic solid tumor(s) for which no effective standard therapy is available or tolerable.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Life expectancy ≥12 weeks.
• Subject must have adequate organ function
• Fertile men and women of childbearing potential must agree to use an effective method of birth control from providing signed consent and for 180 days after last investigational product administration. Women of childbearing potential include pre-menopausal women and women within the first 2 years of the onset of menopause.

You may not qualify if:

• Subjects receiving cancer therapy (chemotherapy or other systemic anti-cancer therapies, immunotherapy, or radiation therapy) within 4 weeks before the first investigational product administration..
• Has not recovered from adverse events (e.g., returned to baseline or grade 0\~1) due to a previously administered agent.
• Note: Subjects with Grade 2 alopecia or anemia are exceptions to this criterion and may qualify for the study.
• Had major surgery within 4 weeks before dosing, or will not have fully recovered from surgery; or has surgery planned during the time the subject is expected to participate in the study or within 4 weeks after the last dose of study drug administration.
• Use of any investigational anti-cancer drug within 28 days 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.
• Primary CNS malignancy; Or a second primary tumor other than the confirmed solid tumor within the previous 3 years
• Evidence of serious or uncontrolled systemic disease (e.g., unstable or decompensated respiratory disease, liver disease or kidney disease)
• Patients with gastrointestinal diseases (such as chronic gastritis, chronic enteritis or gastric ulcers), or with a previous history of severe or chronic diarrhea
• History of chronic skin disease and present skin disease (e.g. bullous dermatitis, acnelike rash, skin ulcer, etc.)
• Subjects with clinically significant cardiovascular disease as defined by the following:
• Baseline left ventricular ejection fraction (LVEF) ≤ 50% measured by Echocardiogram (ECHO) or Multi-gated acquisition (MUGA)
• Heart failure New York Heart Association (NYHA) Class II or above

Sponsors & Collaborators

• Shanghai Escugen Biotechnology Co., Ltd: lead

Study Sites (3)

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100021, China

Location

Tianjin Medical University Cancer Institute & Hospital

Tianjin, Tianjin Municipality, 300060, China

Location

The Second Affiliated Hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310003, China

Location

Related Publications (2)

• Wang J, Zhang Y, Bai R, Wu Y, Tong Z, Liu A, Zhang Y, Wang H, Wu X, Cheng Y, Yang H, Zhou Q, Xing X, Chen X, Qiu F, Ma F. Novel TROP2 antibody-drug conjugates for treatment of HER2-negative metastatic breast cancer patients with brain metastases: a promising option☆. ESMO Open. 2025 May;10(5):105059. doi: 10.1016/j.esmoop.2025.105059. Epub 2025 May 12.

  PMID: 40359710 DERIVED

• Wang J, Tong Z, Tan Y, Shi Y, Wu Y, Zhou Q, Xing X, Chen X, Qiu F, Ma F. Phase 1a study of ESG401, a Trop2 antibody-drug conjugate, in patients with locally advanced/metastatic solid tumors. Cell Rep Med. 2024 Sep 17;5(9):101707. doi: 10.1016/j.xcrm.2024.101707. Epub 2024 Aug 30.

  PMID: 39216478 DERIVED

MeSH Terms

Conditions

Breast Neoplasms; Lung Neoplasms; Colorectal Neoplasms; Urinary Bladder Neoplasms; Stomach Neoplasms; Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Urologic Neoplasms; Urogenital Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases; Stomach Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Genital Neoplasms, Female; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Study Officials

• Fei Ma

  Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Sequential Assignment

Study Record Dates

• First Submitted: May 13, 2021
• First Posted: May 19, 2021
• Study Start: September 14, 2021
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: September 12, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)