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Non-Small Cell Lung CancerPhase 2NCT06623136

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

A Phase 2 study testing ES102 and Toripalimab in people with Non-Small Cell Lung Cancer, run by Elpiscience (Suzhou) Biopharma, Ltd. at 9 sites in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Non-Small Cell Lung Cancer
What is being tested?
ES102 and Toripalimab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
9 sitesChina
Study dates
30 Apr 2025to 31 Dec 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

China9 sites

  • Beijing Chest Hospital, Capital Medical University

    Beijing, Beijing Municipality

  • Jilin Cancer Hospital

    Changchun, Jilin

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

    Jinan, Shandong

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

    Luoyang

  • The First Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi

  • Shanxi Provincial Cancer Hospital

    Taiyuan

  • Taizhou Hospital

    Taizhou

  • Henan Cancer Hospital

    Zhengzhou, Henan

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan

Other trials in China

About this study

Official title: 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).

Being tested
ES102, Toripalimab
Keywords
OX40, PD-1, ES102, JS001, Solid Tumors, INBRX-106
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ES102Drug

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

  • ToripalimabDrug

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

Study groups in NCT06623136
Study groupRoleWhat they receive
ES102 in combination with ToripalimabExperimentalNot described
Receives: Drug: ES102; Drug: Toripalimab

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: 1-2 years

Secondary outcomes (8)

  1. ORR assessed by investigators

    Proportion of subjects achieving CR or PR according to RECIST v1.1 as assessed by investigators.

    Measured: 1-2 years

  2. 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.

    Measured: 1-2 years

  3. 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.

    Measured: 1-2 years

  4. 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.

    Measured: 1-2 years

  5. Overall survival (OS)

    The time from the date of first study drug administration to the date of death due to any cause.

    Measured: 1-2 years

  6. 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.

    Measured: 1-2 years

  7. Plasma concentration

    Plasma concentration will be obtained by laboratory testing of blood samples taken from subjects before and after administration of the study drug.

    Measured: 1-2 years

  8. Immunogenicity Toripalimab

    Frequency of anti-drug antibodies (ADA) against ES102 or Toripalimab will be determined.

    Measured: 1-2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Oct 2024
  2. Study start30 Apr 2025
  3. Primary completion28 Feb 2027 (estimated)
  4. Study completion31 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06623136
Sponsor's protocol ID
ES102-2001
Status last verified
Oct 2026
First submitted
30 Sep 2024
Last updated
20 Oct 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ES102 and Toripalimab in people with Non-Small Cell Lung Cancer, run by Elpiscience (Suzhou) Biopharma, Ltd. at 9 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (ORR) assessed by IRC (time frame: 1-2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06623136.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026.

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