ES102 will be escalated in patients with advanced solid tumors.

Subjects with advanced non-small cell lung cancer, advanced esophageal squamous cell carcinoma, other advanced solid tumors (such as nasopharyngeal carcinoma, cervical cancer, gastrointestinal tumors, other reproductive system tumors, etc.) will be treated with ES102 at the RP2D.

ES102 is administered via intravenous injection once every 21 days, every 21 days as a treatment cycle.

ES102

The purpose of this study is to evaluate the safety, tolerance, Dose-Limiting Toxicity (DLT), Maximum tolerated dose (MTD) and/or Recommended Phase 2 Dose (RP2D) of ES102 (OX40 Agonist) administered as a single agent in patients with advanced solid tumors.

A Study of ES102 (OX40 Agonist) in Patients With Advanced Solid Tumors

An Open-label, Multicenter, Dose-escalation and Cohort Expansion Phase 1 Clinical Study of ES102 Administered as a Single Agent in Patients With Advanced Solid Tumors

The MTD and/or RP2D of ES102 will be determined.

The safety profile of ES102 will be assessed 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 ES102 will be determined.

Maximum observed serum concentration (Cmax) of ES102 will be determined.

Trough observed serum concentration (Ctrough) of ES102 will be determined.

Time to Cmax (Tmax) of ES102 will be determined.

Frequency of anti-drug antibodies (ADA) against ES102 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.

All Drugs and Chemicals

Antibodies

Immunoglobulins

Immunoglobulin G

ES102 will be escalated, in combination with JS001, in patients with advanced solid tumors.

Subjects will be treated with ES102 at the RP2D in combination with JS001.

The active ingredient of ES102 is a recombinant, humanized, hexavalent IgG antibody that targets the human OX40 receptor (TNFRSF4)

JS001 is administered via intravenous injection once every 21 days, every 21 days as a treatment cycle.

JS001

Ning Chen

Ning Zhang

The purpose of this study is to evaluate the safety, tolerance, Dose-Limiting Toxicity (DLT), Maximum tolerated dose (MTD) and/or Recommended Phase 2 Dose (RP2D) of ES102 (OX40 agonist) in combination with JS001 (anti-PD-1 checkpoint inhibitor) in patients with advanced solid tumors.

A Study of ES102 (OX40 Agonist) in Combination With JS001 in Patients With Advanced Solid Tumors

An Open-label, Multicenter, Dose-escalation and Cohort Expansion Phase 1 Clinical Study of ES102 in Combination With JS001 in Patients With Advanced Solid Tumors

Maximum Tolerated Dose (MTD) of ES102 in combination with JS001

The safety profile of ES102 in combination with JS001 will be assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 5.0.

Recommended Phase 2 Dose (RP2D) of ES102 in combination with JS001

Area under the serum concentration time curve (AUC) of ES102 in combination with JS001 will be determined.

Maximum observed serum concentration of ES102 in combination with JS001 will be determined.

Trough observed serum concentration (Ctrough) of ES102 in combination with JS001 will be determined.

Time to Cmax (Tmax) of ES102 in combination with JS001 will be determined.

Frequency of anti-drug antibodies (ADA) against ES102 in combination with JS001 will be determined.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study of ES102 (OX40 Agonist) in Patients With Advanced Solid Tumors	NCT04730843	Solid Tumors Neoplasms Malignant Tumor	ES102	18 Years -	Elpiscience Biopharma, Ltd.
A Study of ES102 (OX40 Agonist) in Combination With JS001 in Patients With Advanced Solid Tumors	NCT04991506	Solid Tumor Neoplasms Malignant Tumor	ES102 JS001	18 Years -	Elpiscience Biopharma, Ltd.
A Study of ES102 (OX40 Agonist) in Combination With JS001 in Patients With Advanced Solid Tumors	NCT04991506	Solid Tumor Neoplasms Malignant Tumor	ES102 JS001	18 Years -	Elpiscience Biopharma, Ltd.

Spots Global Cancer Trial Database for es102

Every month we try and update this database with for es102 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 es102

Every month we try and update this database with for es102 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 es102 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.