Actively Recruiting
Study of ESG406 in Adults With Solid Tumors
Led by Shanghai Escugen Biotechnology Co., Ltd · Updated on 2025-09-12
556
Participants Needed
3
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Study of ESG406 in Adults With Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 will not qualify if you...
- 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.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Chongqing University Cancer Hospital
Chongqing, Chongqing Municipality, China, 400030
Actively Recruiting
2
The First Affiliated Hospital of Xi 'An Jiaotong University
Xi’an, Shanxi, China, 710061
Actively Recruiting
3
The Second Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310009
Actively Recruiting
Research Team
X
Xiaoyan Xing, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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