Study of ESG406 in Adults With Solid Tumors

NCT ID: NCT06979674

Last Updated: 2025-09-12

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 556 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-04
• Study Completion Date: 2028-06-30

Brief Summary

This study is an open-label, dose-escalation and cohort expansion Phase I study, aiming to evaluate the safety, tolerability, PK characteristics and preliminary efficacy of ESG406, and determine the MTD, RP2D and administration regimens of ESG406. The study includes the dose escalation study in Phase Ia and the cohort expansion study in Phase Ib.

Conditions

Locally Advanced/Metastatic Solid Tumors

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ESG406 for injection

The dosage is calculated based on the weight of the subjects and the corresponding dose group. Subjects will receive treatment until disease progression, or starts a new tumor treatment, or stops taking medication for other reasons.

Group Type: EXPERIMENTAL

ESG406

Intervention Type: DRUG

Administered via intravenous (IV) infusion.

Interventions

ESG406

Administered via intravenous (IV) infusion.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Males and females aged 18 to 80 years.
• Histologically or cytologically confirmed advanced or metastatic solid tumor(s) for which no effective standard therapy is available or tolerable.
• At least one measurable lesion per RECIST v1.1.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Life expectancy ≥12 weeks.
• Adequate organ and bone marrow 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.

Exclusion Criteria

• Use of any cancer therapy (chemotherapy or other systemic anti-cancer therapies, immunotherapy) within 4 weeks before the first investigational product administration.
• Toxicities from prior anti-tumor therapy not recovering to ≤ Grade 1.
• 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 4 weeks or 5 half-lives before the first investigational product administration.
• A history of thromboembolic or cerebrovascular events within 6 months prior to the first dose of the investigational drug.
• History of (noninfectious) interstitial pneumonia (ILD)/noninfectious pneumonitis requiring steroid therapy and current ILD/noninfectious pneumonitis, or suspected ILD/noninfectious pneumonitis at screening.
• 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.
• Subjects with clinically significant cardiovascular disease.
• Human Immunodeficiency Virus (HIV) infection.
• Active hepatitis B or hepatitis C.
• Have an allergic constitution, or to be allergic to any investigational drug or excipient ingredient.
• Pregnant or lactating women.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Escugen Biotechnology Co., Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Fuming Qiu, PhD

Role: PRINCIPAL_INVESTIGATOR

Second Affiliated Hospital, School of Medicine, Zhejiang University

Locations

Chongqing University Cancer Hospital

Chongqing, Chongqing Municipality, China

Site Status: RECRUITING

The First Affiliated Hospital of Xi 'An Jiaotong University

Xi’an, Shanxi, China

Site Status: RECRUITING

The Second Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Site Status: RECRUITING

Countries

China

Central Contacts

Xiaoyan Xing, PhD

Role: CONTACT

xingxiaoyan@escugen.com

+86 21 5855 6098

Facility Contacts

Yongsheng Li, PhD

Role: primary

Ruifang An, PhD

Role: primary

Fuming Qiu, PhD

Role: primary

Other Identifiers

ESG406-101

Identifier Type: -

Identifier Source: org_study_id