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

NCT05717348 | Active Not Recruiting Phase 1

• 1 other identifier: ES014-1002
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Solid Tumor; Locally Advanced Solid Tumor; Metastatic Solid Tumor

Keywords

CD39; TGF-β; CD39xTGF-β

Outcome Measures

Primary Outcomes (2)

• The frequency and severity of adverse events of ES014

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

  1-3 years

• Dose Limiting Toxicity of ES014

  Evaluation of dose-limiting toxicity (DLT)

  1-3 years

Secondary Outcomes (9)

• Maximum observed serum concentration (Cmax) of ES014

  1-3 years

• Trough observed serum concentration (Ctrough) of ES014

  1-3 years

• Area under the serum concentration time curve (AUC) of ES014

  1-3 years

• Time to Cmax (Tmax) of ES014

  1-3 years

• The terminal elimination half life of ES014

  1-3 years

Study Arms (2)

Part 1 dose escalation

EXPERIMENTAL

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

Drug: ES014

Part 2 dose expansion

EXPERIMENTAL

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

Drug: ES014

Interventions

ES014 DRUG

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.

Part 1 dose escalation; Part 2 dose expansion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Unresectable locally advanced or metastatic solid tumour diagnosed by pathology or cytology and which meets the criteria of 1) disease progression has occurred despite receiving standard treatment and no other standard treatment is available; or 2) standard treatment has been proven to be ineffective, intolerant or considered unsuitable.
• \. Provide tumor tissue samples.
• \. At least one measurable lesion per RECIST v1.1.
• \. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1. Part 1: ECOG PS 0-1. Part 2: ECOG PS 0-2.
• \. Life expectancy of at least 12 weeks.
• \. Adequate hematologic, hepatic, renal and coagulation functions per protocol.
• \. Male and female subjects of childbearing potential must be willing to completely abstain or agree to use a highly effective method of contraception.

You may not qualify if:

• \. Any prior therapy targeting CD39, CD73, adenosine A2A receptor, or TGF-β.
• \. Receipt of any investigational agents or devices within 4 weeks prior to the first dose of study drug.
• \. Prior treatment with the following therapies: 1) Anticancer therapy within 30 days or 5 half-lives of the drug prior to the first dose of study drug. At least 14 days must have elapsed between the last dose of prior anticancer agent and the first dose of study drug is administered with certain exceptions. 2) A wash out of at least 2 weeks before the start of study drug for radiation to the extremities and 4 weeks for radiation to the chest, brain, or visceral organs is required.
• \. Prior allogeneic or autologous bone marrow transplantation or solid organ transplantation.
• \. Toxicity from previous anticancer treatment per protocol.
• \. Treatment with systemic immunosuppressive medications within 4 weeks prior to the first dose of study drug.
• \. Subjects who received transfusion of blood products (including platelets or red blood cells), G-CSF, GM-CSF, recombinant erythropoietin, or recombinant thrombopoietin within 14 days prior to the first dose of study treatment.
• \. Major surgery within 4 weeks prior to the first dose of study treatment.
• \. Live vaccine therapies within 4 weeks prior to the first dose of study treatment.
• \. Recent history of allergen desensitization therapy within 4 weeks prior to the first dose of study treatment.
• \. Known allergies to CHO-produced antibodies, which in the opinion of the Investigator suggests an increased potential for an adverse hypersensitivity to ES014.
• \. Invasive malignancy or history of invasive malignancy other than disease under study within the last two years per protocol.
• \. CNS metastases.
• \. Active autoimmune disease or documented history of autoimmune disease that required systemic steroids or other immunosuppressive medications per protocol.
• \. Active interstitial lung disease (ILD) or pneumonitis or a history of ILD or pneumonitis requiring treatment with steroids or other immunosuppressive medications.

Sponsors & Collaborators

• Elpiscience (Suzhou) Biopharma, Ltd.: lead

Study Sites (1)

Shanghai Chest Hospital

Shanghai, China

Location

MeSH Terms

Conditions

Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2023
• First Posted: February 8, 2023
• Study Start: February 24, 2023
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): February 28, 2027
• Last Updated: August 13, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)