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

NCT06623136 | Recruiting Phase 2

• 1 other identifier: ES102-2001
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 9

Brief Summary

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

Non-Small Cell Lung Cancer

Keywords

OX40; PD-1; ES102; JS001; Solid Tumors; INBRX-106

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• ORR assessed by investigators

  1-2 years

• Disease control rate (DCR)

  1-2 years

• Duration of response (DOR)

  1-2 years

• Progression-free survival (PFS)

  1-2 years

• Overall survival (OS)

  1-2 years

Study Arms (1)

ES102 in combination with Toripalimab

EXPERIMENTAL

Drug: ES102; Drug: Toripalimab

Interventions

ES102 DRUG

ES102 is administered via intravenous infusion, once every 21 days.

ES102 in combination with Toripalimab

Toripalimab DRUG

Toripalimab is administered via intravenous infusion, once every 21 days.

ES102 in combination with Toripalimab

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Elpiscience (Suzhou) Biopharma, Ltd.: lead

Study Sites (9)

Beijing Chest Hospital, Capital Medical University

Beijing, Beijing Municipality, China

RECRUITING

Henan Cancer Hospital

Zhengzhou, Henan, China

RECRUITING

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

RECRUITING

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

NOT YET RECRUITING

Jilin Cancer Hospital

Changchun, Jilin, China

RECRUITING

Cancer Hospital of Shandong First Medical University (Shandong Cancer Institute, Shandong Cancer Hospital)

Jinan, Shandong, China

NOT YET RECRUITING

The First Affiliated Hospital of He'nan University of Science and Technology

Luoyang, China

RECRUITING

Shanxi Provincial Cancer Hospital

Taiyuan, China

RECRUITING

Taizhou Hospital

Taizhou, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

toripalimab

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Amy Ren

CONTACT

86-021-50651310; ClinicalOperation@elpiscience.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2024
• First Posted: October 2, 2024
• Study Start: April 30, 2025
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: September 26, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (9)