All Drugs and Chemicals

Antibodies

Antibodies, Bispecific

Immunoglobulins

ES101 will be escalated in patients with advanced solid tumors.

Subjects with solid tumors will be treated with single-agent ES101 at either specified dose levels or RP2D.

ES101 is administered via intravenous infusion, once every 14 days, every 28 days as a treatment cycle.

ES101

The purpose of this study is to evaluate the safety, tolerance and Dose-Limiting Toxicity (DLT) of recombinant humanized PD-L1/4-1BB bispecific antibody (ES101) in patients with advanced solid tumors.

ES101 (INBRX-105; PDL1x4-1BB antibody) is a recombinant humanized bispecific IgG1 antibody targeting human PD-L1 and 4-1BB. This is an open-label, multicenter, dose-escalation and cohort expansion phase 1 clinical study to evaluate the safety and pharmacokinetic characteristics and preliminary anti-tumor activity of ES101 in patients with advanced malignant solid tumors whose disease has progressed despite standard therapy, or who has no further standard therapy, or who is unsuitable for available standard treatment options.

A Study of ES101 (PD-L1x4-1BB Bispecific Antibody) in Patients With Advanced Solid Tumors

An Open-label, Multicenter, Dose-escalation and Cohort Expansion Phase 1 Clinical Study of ES101 in Patients With Advanced Solid Tumors

The MTD and/or RP2D of ES101 will be determined.

Adverse events will be assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 5.0.

Severity of adverse events will be assessed and assigned by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 5.0.

Area under the serum concentration time curve (AUC) of ES101 will be determined.

Maximum observed serum concentration (Cmax) of ES101 will be determined.

Trough observed serum concentration (Cmax) of ES101 will be determined.

Time to Cmax (Tmax) of ES101 will be determined.

Frequency of anti-drug antibodies (ADA) against ES101 will be determined.

Tumor response will be determined by the revised Response Evaluation Criteria in Solid Tumors version 1.1 (RECISTv1.1).

Elpiscience Biopharma, Ltd.

Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Rare Diseases

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Small Cell Lung Carcinoma

Thoracic Neoplasms

Carcinoma

Respiratory Tract Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Small Cell Lung Cancer

Immunoglobulin G

ES101 is administered via intravenous infusion, 0.3mg/kg，once every 14 days, every 28 days as a treatment cycle.

ES101 is administered via intravenous infusion, 1mg/kg，once every 14 days, every 28 days as a treatment cycle.

ES101 is administered via intravenous infusion, RP2D (to be determined)，once every 14 days, every 28 days as a treatment cycle.

The active ingredient of ES101 is a recombinant, humanized, bispecific IgG antibody that targets the human programmed death-ligand 1 (PD-L1) receptor and the human 4-1BB receptor.

The purpose of this study is to evaluate the safety, RP2D and PK/pharmacodynamic profile of ES101 monotherapy in patients with advanced NSCLC and to further evaluate the antitumor efficacy of ES101 in advanced malignant thoracic tumors, including NSCLC and SCLC.

A Study of ES101 (PD-L1x4-1BB Bispecific Antibody) in Patients With Advanced Malignant Thoracic Tumors

An Open-label, Multicenter, Multicohort Phase 1b/2 Clinical Trial of ES101 in Patients With Advanced Malignant Thoracic Tumors

Adverse events will be assessed and assigned by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 5.0.

Assess the relationship between ES101 exposure and efficacy/adverse events.

Assess PD-L1 receptor occupancy and cytokines

Assess PD-L1 expression status of tumor tissues

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study of ES101 (PD-L1x4-1BB Bispecific Antibody) in Patients With Advanced Solid Tumors	NCT04009460	Solid Tumors Neoplasms Malignant Tumor	ES101	18 Years -	Elpiscience Biopharma, Ltd.
A Study of ES101 (PD-L1x4-1BB Bispecific Antibody) in Patients With Advanced Malignant Thoracic Tumors	NCT04841538	Thoracic Tumors Non-small Cell ... Small Cell Lung...	ES101	18 Years -	Elpiscience Biopharma, Ltd.
A Study of ES101 (PD-L1x4-1BB Bispecific Antibody) in Patients With Advanced Malignant Thoracic Tumors	NCT04841538	Thoracic Tumors Non-small Cell ... Small Cell Lung...	ES101	18 Years -	Elpiscience Biopharma, Ltd.

Spots Global Cancer Trial Database for es101

Every month we try and update this database with for es101 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for es101

Every month we try and update this database with for es101 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for es101 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.