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

Elpiscience (Suzhou) Biopharma, Ltd.9 sites in 1 country40 target enrollmentApril 30, 2025

ConditionsNon-Small Cell Lung Cancer

InterventionsES102 Toripalimab

DrugsES102 Toripalimab

Overview

Phase: Phase 2
Intervention: ES102
Conditions: Non-Small Cell Lung Cancer
Sponsor: Elpiscience (Suzhou) Biopharma, Ltd.
Enrollment: 40
Locations: 9
Primary Endpoint: Objective Response Rate (ORR) assessed by IRC
Status: Recruiting
Last Updated: 7 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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).

Registry

clinicaltrials.gov

Start Date

April 30, 2025

End Date

December 31, 2027

Last Updated

7 months ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Elpiscience (Suzhou) Biopharma, Ltd.

Responsible Party

Sponsor

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
•Estimated life expectancy of at least 3 months.

Exclusion Criteria

•Any prior therapy targeting OX
•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.
•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.

Arms & Interventions

ES102 in combination with Toripalimab

Intervention: ES102

ES102 in combination with Toripalimab

Intervention: Toripalimab

Outcomes

Primary Outcomes

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).