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

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: Recruiting
• Conditions: Non-Small Cell Lung Cancer
• Intervention / Treatment: Drug: ES102; Drug: Toripalimab

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Amy Ren; Phone Number: 86-021-50651310; Email: ClinicalOperation@elpiscience.com

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

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Objective Response Rate (ORR) assessed by IRC	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

Outcome Measure	Measure Description	Time Frame
ORR assessed by investigators	Proportion of subjects achieving CR or PR according to RECIST v1.1 as assessed by investigators.	1-2 years
Disease control rate (DCR)	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)	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 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)	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)	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	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	Frequency of anti-drug antibodies (ADA) against ES102 or Toripalimab will be determined.	1-2 years

Collaborators and Investigators

• Sponsor: Elpiscience (Suzhou) Biopharma, Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): April 30, 2025
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: September 30, 2024
• First Submitted That Met QC Criteria: September 30, 2024
• First Posted (Actual): October 2, 2024

Study Record Updates

• Last Update Posted (Estimated): September 26, 2025
• Last Update Submitted That Met QC Criteria: September 25, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: PD-1; Solid Tumors; ES102; JS001; OX40; INBRX-106
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Carcinoma, Non-Small-Cell Lung; toripalimab
• Other Study ID 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