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Status:

RECRUITING

Study of ESG406 in Adults With Solid Tumors

Lead Sponsor:

Shanghai Escugen Biotechnology Co., Ltd

Conditions:

Locally Advanced/Metastatic Solid Tumors

Eligibility:

All Genders

18-80 years

Phase:

PHASE1

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 M...

Eligibility Criteria

Inclusion

  • Key
  • 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.
  • Key

Exclusion

  • 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.

Key Trial Info

Start Date :

June 4 2025

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

June 1 2028

Estimated Enrollment :

556 Patients enrolled

Trial Details

Trial ID

NCT06979674

Start Date

June 4 2025

End Date

June 1 2028

Last Update

September 12 2025

Active Locations (3)

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Page 1 of 1 (3 locations)

1

Chongqing University Cancer Hospital

Chongqing, Chongqing Municipality, China, 400030

2

The First Affiliated Hospital of Xi 'An Jiaotong University

Xi’an, Shanxi, China, 710061

3

The Second Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China, 310009