Study of ESG406 in Adults With Solid Tumors

NCT06979674 | Recruiting Phase 1

• 1 other identifier: ESG406-101
• Study Type: interventional
• Target: 556
• Locations: 1 country
• Sites: 3

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

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (6)

• Objective Response Rate

  Up to approximately 36 months.

• Progression Free Survival

  Up to approximately 36 months.

• Cmax

  Up to approximately 36 months.

• AUC0-inf

  Up to approximately 36 months.

• T1/2

  Up to approximately 36 months.

Study Arms (1)

ESG406 for injection

EXPERIMENTAL

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.

Drug: ESG406

Interventions

ESG406 DRUG

Administered via intravenous (IV) infusion.

ESG406 for injection

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Escugen Biotechnology Co., Ltd: lead

Study Sites (3)

Chongqing University Cancer Hospital

Chongqing, Chongqing Municipality, 400030, China

RECRUITING

The First Affiliated Hospital of Xi 'An Jiaotong University

Xi’an, Shanxi, 710061, China

RECRUITING

The Second Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310009, China

RECRUITING

Study Officials

• Fuming Qiu, PhD

  Second Affiliated Hospital, School of Medicine, Zhejiang University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaoyan Xing, PhD

CONTACT

+86 21 5855 6098; xingxiaoyan@escugen.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2025
• First Posted: May 20, 2025
• Study Start: June 4, 2025
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: September 12, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)