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ES014 doses will be escalated in patients with advanced solid tumors with approximately 30 subjects.

Part 2 of the study will consist of 3 expansion cohorts for pancreatic ductal adenocarcinoma (Cohort 2A), NSCLC (Cohort 2B), and colorectal adenocarcinoma (Cohort 2C) with 10 subjects per expansion cohort respectively at the recommended optimal biological dose determined in Part 1 dose escalation.

ES014 is administered via intravenous infusion, once every 14 days, every 28 days as a treatment cycle for a maximum treatment duration per patient of 2 years.

ES014

Elpiscience Biopharma, Ltd.

The purpose of this first-in-human, open-label, multicenter, non-randomized study designed to determine the maximum tolerated dose (MTD)/maximum administered dose (MAD), optimal biological dose (OBD), and recommended phase 2 dose (RP2D) of ES014 by evaluating the safety, tolerability, PK, pharmacodynamics, and preliminary clinical activity of ES014 administered intravenously to subjects with advanced solid tumors.

Adenosine and transforming growth factor-β (TGF-β) are two key immune suppressors in the tumor microenvironment (TME) that cause broad immune suppression resulting in resistance to current checkpoint inhibitor immunotherapies. The bifunctional antibody-fusion protein ES014 was created by fusing the TGF-β receptor II ectodomain to an antibody targeting human ectonucleoside triphosphate diphosphohydrolase-1 (ENTPD1, CD39, UniprotKB: P49961). ES014 simultaneously neutralizes autocrine/paracrine TGF-β and inhibits the enzymatic activity of CD39, which results in the stabilization of pro-inflammatory extracellular adenosine triphosphate (eATP) and the restoration of anti-tumor immunity by impairing the accumulation of immune suppressive adenosine and TGF-β within the TME.

A Study of ES014 (Anti-CD39/TGF-β Bispecific Antibody) in Patients With Locally Advanced or Metastatic Solid Tumors

An Open-Label, Multicenter, First-in-Human, Dose Escalation and Expansion, Phase 1 Study of ES014 in Subjects With Locally Advanced or Metastatic Solid Tumors

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

\[Time Frame: 1-3 years\]

Evaluation of dose-limiting toxicity (DLT)

Maximum observed serum concentration (Cmax) of ES014 will be measured.

Trough observed serum concentration (Ctrough)of ES014 will be measured.

Area under the serum concentration time curve (AUC) of ES014 will be measured

Time to Cmax (Tmax) of ES014 will be measured

The terminal elimination half-life (t 1/2) of ES014 will be measured

A pharmacokinetic measurement of the volume of plasma from which ES014 is completely removed per unit time

The amount of of ES014 in the body divided by the plasma concentration will be measured

The presence and the frequency of anti-drug antibodies (ADA) against ES014 will be measured

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

ES014 doses will be escalated in patients with advanced solid tumors.

Part 2 of the study will consist of 4 expansion cohorts at the recommended optimal biological dose determined in Part 1 dose escalation.

Chang Su

Shun Lu, Doctor

A Study of ES014 in Patients With Locally Advanced or Metastatic Solid Tumours

An Open-label, Multicenter, Dose-escalation and Cohort Expansion Phase 1 Clinical Study of ES014 Administered in Patients Locally Advanced or Metastatic Solid Tumours

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 ES014 will be measured.

Time to Cmax (Tmax) of ES014 will be measured.

The terminal elimination half-life (t 1/2) of ES014 will be measured.

A pharmacokinetic measurement of the volume of plasma from which ES014 is completely removed per unit time.

The amount of of ES014 in the body divided by the plasma concentration will be measured.

The presence and the frequency of anti-drug antibodies (ADA) against ES014 will be measured.

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

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study of ES014 (Anti-CD39/TGF-β Bispecific Antibody) in Patients With Locally Advanced or Metastatic Solid Tumors	NCT05381935	Advanced Solid ...	ES014 ES014	18 Years -	Elpiscience Biopharma, Ltd.
A Study of ES014 in Patients With Locally Advanced or Metastatic Solid Tumours	NCT05717348	Solid Tumor Locally Advance... Metastatic Soli...	ES014	18 Years -	Elpiscience (Suzhou) Biopharma, Ltd.
A Study of ES014 (Anti-CD39/TGF-β Bispecific Antibody) in Patients With Locally Advanced or Metastatic Solid Tumors	NCT05381935	Advanced Solid ...	ES014 ES014	18 Years -	Elpiscience Biopharma, Ltd.

Spots Global Cancer Trial Database for es014

Every month we try and update this database with for es014 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 es014

Every month we try and update this database with for es014 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 es014 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.