Study of ESG406 in Adults With Solid Tumors

Phase 1

Not yet recruiting

• Conditions: Locally Advanced/Metastatic Solid Tumors
• Interventions: Drug: ESG406

• Registration Number: NCT06979674
• Lead Sponsor: Shanghai Escugen Biotechnology Co., Ltd

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-05
• Study First Submitted: 2025-05-13
• Study First Submitted QC: 2025-05-13
• Last Update Submitted: 2025-05-13
• Study First Posted: 2025-05-20
• Last Update Posted: 2025-05-20
• Study Start: 2025-06
• Primary Completion: 2028-04
• Study Completion: 2028-06

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 556

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.

Key

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ESG406 for injection	ESG406	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.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Experiencing Any Treatment Emergent Adverse Events and Serious Treatment Emergent Adverse Events	First dose date up to last dose plus 30 days	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.

Secondary Outcome Measures

Name	Time	Method
Objective Response Rate	Up to approximately 36 months.	Objective Response Rate(ORR) is defined as the rate an overall best response of either complete response (CR) or partial response (PR) .
Progression Free Survival	Up to approximately 36 months.	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.
AUC0-inf	Up to approximately 36 months.	Area under the serum concentration time curve from time 0 extrapolated to infinity
Cmax	Up to approximately 36 months.	Maximum observed plasma concentration
T1/2	Up to approximately 36 months.	Half-life
Anti-drug Antibodies	Up to approximately 36 months.	Incidence of anti-drug antibodies