Evaluating ES102 with Toripalimab for advanced 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

This study is testing if a new drug called ES102, when used with Toripalimab, can help people with advanced lung cancer who haven't had much treatment before.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Elpiscience Biopharma, Ltd. (Industry-sponsored)
• Drugs / interventions: ofToripalimab, chemotherapy, immunotherapy, prednisone, Toripalimab
• Locations: 9 sites (Beijing, Beijing Municipality and 8 other locations)
• Trial ID: NCT06623136 on ClinicalTrials.gov

What this trial studies

This study aims to assess the efficacy, safety, tolerability, pharmacokinetics, and immunogenicity of the drug ES102 when combined with Toripalimab in patients suffering from advanced non-small cell lung cancer (NSCLC). Participants will be closely monitored for their response to the treatment and any potential side effects. The study focuses on patients who have previously undergone limited systemic therapies and are not candidates for radical treatment options. The combination therapy is expected to enhance the immune response against the cancer.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-75 with unresectable advanced NSCLC who have limited prior systemic treatment.

Not a fit: Patients with known EGFR mutations, ALK fusions, or ROS1 fusions may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced non-small cell lung cancer.

How similar studies have performed: While this approach is innovative, similar studies combining immune checkpoint inhibitors have shown promise in treating advanced lung cancer.

Eligibility criteria

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.

Where this trial is running

Beijing, Beijing Municipality and 8 other locations

• 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)

Study contacts

• Study coordinator: Amy Ren

Conditions Non-Small Cell Lung Cancer; OX40; PD-1; ES102; JS001; Solid Tumors; INBRX-106