Actively Recruiting
A Study of ES102 in Combination With Toripalimab in Subjects With Advanced Non-small Cell Lung Cancer
Led by Elpiscience (Suzhou) Biopharma, Ltd. · Updated on 2025-09-26
40
Participants Needed
9
Research Sites
139 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The aim of this study is to evaluate the efficacy, safety, tolerability, pharmacokinetics (PK) and immunogenicity of ES102 in combination with Toripalimab in subjects with advanced non-small cell lung cancer (NSCLC).
CONDITIONS
Official Title
A Study of ES102 in Combination With Toripalimab in Subjects With Advanced Non-small Cell Lung Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Understanding of the study and willingness to sign informed consent
- Male or female aged 18 to 75 years
- Confirmed unresectable locally advanced or metastatic non-small cell lung cancer not suitable for radical chemoradiotherapy
- No known EGFR mutation, ALK fusion, or ROS1 fusion gene
- Previous failure of systemic platinum-containing chemotherapy and PD-1/PD-L1 inhibitor therapy
- Availability of tumor tissue for PD-L1 testing
- PD-L1 tumor proportion score of 50% or higher
- At least one measurable lesion per RECIST v1.1
- ECOG performance status of 0 or 1
- Estimated life expectancy of at least 3 months
- Adequate blood, liver, kidney, and coagulation function
- Willingness to use effective contraception or complete abstinence if of childbearing potential
You will not qualify if you...
- Prior therapy targeting OX40
- Receipt of other investigational drugs or devices within 28 days before the study drug
- Use of anticancer Chinese herbal therapy or radiotherapy within 14 days before the study drug
- Receipt of other anticancer drugs within 28 days or 5 half-lives before the study drug
- Prior bone marrow or solid organ transplant
- Unresolved toxicity from previous anticancer therapies above Grade 1
- Use of systemic glucocorticoids or immunosuppressants within 14 days before or during the study
- Major surgery within 28 days before the study drug
- Receipt of live viral vaccines within 28 days before the study drug
- Known allergy to CHO-produced antibodies, Toripalimab ingredients, or pre-medication
- History of invasive malignant tumors other than NSCLC within past 2 years
- History of severe immune-related adverse events or those causing treatment discontinuation
- Active autoimmune disease requiring systemic corticosteroids or immunosuppressants
- Active interstitial lung disease or pneumonia requiring corticosteroids or immunosuppressants
- Central nervous system metastases
- Active infections requiring systemic treatment, or positive for HIV, HBV, or HCV
- Liver diseases such as cirrhosis or hepatitis
- History or evidence of cardiovascular abnormalities
- Pregnant or breastfeeding women
- History of substance abuse affecting participation
- Any other condition that may affect safety or study integrity
- Study personnel involved in design or implementation
- Inability to comply with study procedures or requirements
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 9 locations
1
Beijing Chest Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Actively Recruiting
2
Henan Cancer Hospital
Zhengzhou, Henan, China
Actively Recruiting
3
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Actively Recruiting
4
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
Not Yet Recruiting
5
Jilin Cancer Hospital
Changchun, Jilin, China
Actively Recruiting
6
Cancer Hospital of Shandong First Medical University (Shandong Cancer Institute, Shandong Cancer Hospital)
Jinan, Shandong, China
Not Yet Recruiting
7
The First Affiliated Hospital of He'nan University of Science and Technology
Luoyang, China
Actively Recruiting
8
Shanxi Provincial Cancer Hospital
Taiyuan, China
Actively Recruiting
9
Taizhou Hospital
Taizhou, China
Actively Recruiting
Research Team
A
Amy Ren
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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