A Study of ES102 in Combination With Toripalimab in Subjects With Advanced Non-small Cell Lung Cancer

September 25, 2025 updated by: Elpiscience (Suzhou) Biopharma, Ltd.

An Open-label, Multicenter, Single-arm Phase 2 Study of ES102 in Combination With Toripalimab in Subjects With Advanced Non-small Cell Lung Cancer

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
      • Luoyang, China
        • Recruiting
        • The First Affiliated Hospital of He'nan University of Science and Technology
        • Contact:
          • Dianbao Zhang
        • Principal Investigator:
          • Dianbao Zhang
      • Taiyuan, China
        • Recruiting
        • Shanxi Provincial Cancer Hospital
        • Contact:
          • Wei Guo
        • Principal Investigator:
          • Wei Guo
      • Taizhou, China
        • Recruiting
        • Taizhou Hospital
        • Contact:
          • Dongqing Lv
        • Principal Investigator:
          • Dongqing LV
    • Beijing Municipality
      • Beijing, Beijing Municipality, China
        • Recruiting
        • Beijing Chest Hospital, Capital Medical University
        • Contact:
          • Boahua Lu
        • Principal Investigator:
          • Baohua Lu
    • Henan
      • Zhengzhou, Henan, China
        • Recruiting
        • Henan Cancer Hospital
        • Principal Investigator:
          • Qiming Wang
        • Contact:
          • Qiming Wang
          • Phone Number: 400-0371-818
      • Zhengzhou, Henan, China
        • Recruiting
        • The First Affiliated Hospital of Zhengzhou University
        • Contact:
          • Siyuan Huang
        • Principal Investigator:
          • Siyuan Huang
    • Jiangxi
      • Nanchang, Jiangxi, China
        • Not yet recruiting
        • The First Affiliated Hospital of Nanchang University
        • Contact:
          • Jianjun Tang
        • Principal Investigator:
          • Jianjun Tang
    • Jilin
      • Changchun, Jilin, China
        • Recruiting
        • Jilin cancer hospital
        • Contact:
          • Haifeng Liu
        • Principal Investigator:
          • Haifeng Liu
    • Shandong
      • Jinan, Shandong, China
        • Not yet recruiting
        • Cancer Hospital of Shandong First Medical University (Shandong Cancer Institute, Shandong Cancer Hospital)
        • Contact:
          • Xiangjiao Meng
        • Principal Investigator:
          • Xiangjiao Meng

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Having sufficient understanding of this study and being willing to sign the informed consent form (ICF).
  • Males or females, age 18-75 years at the time of signing the informed consent form.
  • Histologically or cytologically confirmed, unresectable locally advanced and metastatic non-small cell lung cancer not suitable for radical concurrent chemoradiotherapy.
  • Without known EGFR mutation/ALK fusion/ROS1 fusion gene.
  • Previous failed concurrent or sequential treatment with systemic platinum-containing chemotherapy and PD-1/PD-L1 inhibitor therapy for NSCLC that cannot be radically resected or not suitable for radical concurrent radio chemotherapy.
  • Five consecutive unstained slides from formalin-fixed paraffin-embedded (FFPE) tumor tissue (archived tumor tissue up to 5 years or freshly biopsied tumor tissue) sources are available for PD-L1 testing in the central laboratory.
  • PD-L1 TPS ≥50% by 22C3 antibody IHC assay in the central laboratory.
  • At least one measurable lesion (in accordance with RECIST v1.1).
  • Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1.
  • Estimated life expectancy of at least 3 months.
  • Adequate hematologic, hepatic, renal and coagulation function as defined per protocol.
  • Male and female subjects of childbearing potential must be willing to be completely abstinent or to use a highly effective method of contraception (i.e., a failure rate of less than 1%) from the time of signing the informed consent form until 3 months after the last dose of study drug.

Exclusion Criteria:

  • Any prior therapy targeting OX40.
  • Receipt of any other investigational drug or device intervention within 28 days prior to the first dose of the study drug.
  • Receipt of anticancer Chinese herbal therapy within 14 days prior to the first dose of the study drug.
  • Receipt of radiotherapy within 14 days prior to the first dose of the study drug.
  • Receipt of any other anti-cancer drug(s) including chemotherapy, targeted therapy, immunotherapy, biotherapy, etc., within 28 days or 5 half-lives prior to the first dose of the study drug.
  • Prior allogeneic or autologous bone marrow transplant or solid organ transplant.
  • The toxicity from prior anti-cancer therapies has not resolved to ≤ Grade 1 per NCI-CTCAE v5.0. Certain exceptions as defined in protocol apply.
  • Systemic glucocorticoids (e.g., >10 mg/day of prednisone or equivalent doses of similar drugs) or other immunosuppressive agents were required for systemic treatment within 14 days prior to the first dose of the study drug or during the study period.
  • Major surgery within 28 days prior to the first dose of the study drug.
  • Receipt of live viral vaccine treatment within 28 days prior to the first dose of the study drug.
  • Known allergy to CHO-produced antibodies, which in the opinion of the Investigator suggests an increased potential for hypersensitivity to ES102.
  • Subjects with an allergic reaction to the active ingredients ofToripalimab or any of the excipients.
  • Known allergy to the pre-medication prescribed in the protocol and unable to receive pre-medication.
  • History of invasive malignant tumors other than the study disease within the past two years. Some exceptions as defined per protocol apply.
  • History of immune-related adverse events (irAEs) of Grade ≥3 or those that led to discontinuation of treatment. Some exceptions as defined per protocol apply.
  • Active autoimmune disease or a known history of autoimmune disease requiring systemic corticosteroid or immunosuppressive treatment.
  • Active interstitial lung disease (ILD) or pneumonia; or a history of ILD or (non-infectious) pneumonia requiring corticosteroid or other immunosuppressive treatment.
  • Central Nervous System (CNS) metastases.
  • Active infection requiring systemic treatment; Human Immunodeficiency Virus (HIV) infection (HIV antibody positive); Hepatitis B Virus (HBV) infection (HBsAg positive) or Hepatitis C Virus (HCV) infection (HCV antibody positive). Some exceptions as defined per protocol apply.
  • Cirrhosis, alcoholic hepatitis, drug-induced hepatitis, non-alcoholic steatohepatitis, and hereditary liver diseases.
  • History or evidence of cardiovascular abnormalities.
  • Pregnant or breastfeeding women.
  • Any known, documented, or suspected history of substance abuse that would preclude subject from participation, certain exceptions as defined in protocol apply.
  • Any other disease or clinically significant abnormal laboratory parameters that investigator considers may compromise subject safety or study integrity, interfere with subject participation in the trial, or affect the study objectives, including serious medical or psychiatric illness/condition.
  • Personnel involved in the design and/or implementation of the study (applicable to sponsor/CRO personnel and site personnel).
  • Subjects are unable to comply with the study procedures, restrictions and requirements, in the opinion of Investigator.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: ES102 in combination with Toripalimab
Drug: ES102
ES102 is administered via intravenous infusion, once every 21 days.
Drug: Toripalimab
Toripalimab is administered via intravenous infusion, once every 21 days.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Objective Response Rate (ORR) assessed by IRC
Time Frame: 1-2 years
Proportion of subjects achieving complete response (CR) or partial response (PR) according to RECIST v1.1 as assessed by the Independent Review Committee (IRC).
1-2 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
ORR assessed by investigators
Time Frame: 1-2 years
Proportion of subjects achieving CR or PR according to RECIST v1.1 as assessed by investigators.
1-2 years
Disease control rate (DCR)
Time Frame: 1-2 years
Proportion of subjects achieving CR, PR or stable disease (SD) according to RECIST v1.1 as assessed by IRC and investigators.
1-2 years
Duration of response (DOR)
Time Frame: 1-2 years
The time from first documented evidence of CR or PR to disease progression or death, whichever occurs first, in subjects who demonstrate a CR or PR per RECIST v1.1 , as assessed by IRC and investigators.
1-2 years
Progression-free survival (PFS)
Time Frame: 1-2 years
Time from the date of first study drug administration to disease progression or death, whichever occurs first, as assessed by IRC and investigators.
1-2 years
Overall survival (OS)
Time Frame: 1-2 years
The time from the date of first study drug administration to the date of death due to any cause.
1-2 years
Adverse events (AE)
Time Frame: 1-2 years
The number of subjects who experienced an adverse event (AE) will be presented. AE will be collected beginning with subject receiving first dose of the study drug until the time specified in the protocol.
1-2 years
Plasma concentration
Time Frame: 1-2 years
Plasma concentration will be obtained by laboratory testing of blood samples taken from subjects before and after administration of the study drug.
1-2 years
Immunogenicity Toripalimab
Time Frame: 1-2 years
Frequency of anti-drug antibodies (ADA) against ES102 or Toripalimab will be determined.
1-2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Elpiscience (Suzhou) Biopharma, Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 30, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 28, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 30, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 30, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 2, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 26, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 25, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ES102-2001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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