Solid TumorPhase 1NCT05717348
A Study of ES014 in Patients With Locally Advanced or Metastatic Solid Tumours
A Phase 1 study testing ES014 in people with Solid Tumor and Locally Advanced Solid Tumor, run by Elpiscience (Suzhou) Biopharma, Ltd. at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor, Locally Advanced Solid Tumor, Metastatic Solid Tumor
- What is being tested?
- ES014
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 24 Feb 2023to 28 Feb 2027
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. 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.
- 2. Provide tumor tissue samples.
- 3. At least one measurable lesion per RECIST v1.1.
- 4. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1. Part 1: ECOG PS 0-1. Part 2: ECOG PS 0-2.
- 5. Life expectancy of at least 12 weeks.
- 6. Adequate hematologic, hepatic, renal and coagulation functions per protocol.
- 7. Male and female subjects of childbearing potential must be willing to completely abstain or agree to use a highly effective method of contraception.
Who cannot join
- 1. Any prior therapy targeting CD39, CD73, adenosine A2A receptor, or TGF-β.
- 2. Receipt of any investigational agents or devices within 4 weeks prior to the first dose of study drug.
- 3. 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.
- 4. Prior allogeneic or autologous bone marrow transplantation or solid organ transplantation.
- 5. Toxicity from previous anticancer treatment per protocol.
- 6. Treatment with systemic immunosuppressive medications within 4 weeks prior to the first dose of study drug.
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- 7. 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.
- 8. Major surgery within 4 weeks prior to the first dose of study treatment.
- 9. Live vaccine therapies within 4 weeks prior to the first dose of study treatment.
- 10. Recent history of allergen desensitization therapy within 4 weeks prior to the first dose of study treatment.
- 11. Known allergies to CHO-produced antibodies, which in the opinion of the Investigator suggests an increased potential for an adverse hypersensitivity to ES014.
- 12. Invasive malignancy or history of invasive malignancy other than disease under study within the last two years per protocol.
- 13. CNS metastases.
- 14. Active autoimmune disease or documented history of autoimmune disease that required systemic steroids or other immunosuppressive medications per protocol.
- 15. Active interstitial lung disease (ILD) or pneumonitis or a history of ILD or pneumonitis requiring treatment with steroids or other immunosuppressive medications.
- 16. Active infection requiring systemic therapy, known human immunodeficiency virus (HIV) infection, or positive test for hepatitis B active infection (HBsAg) or hepatitis C active infection (hepatitis C antibody).
- 17. Current active liver or biliary disease with certain exceptions.
- 18. History or evidence of cardiac abnormalities per protocol.
- 19. History of bleeding tendency or a recent major bleeding event which, in the opinion of the investigator, indicates that the subject is at high risk of receiving study treatment.
- 20. Pregnant or nursing females.
- 21. Any known, documented, or suspected history of substance abuse that would preclude subject from participation with certain exceptions.
- 22. Any other disease or clinically significant abnormality in a laboratory parameter, including serious medical or psychiatric disease/condition, that in the opinion of the investigator may compromise the safety of the subject or the integrity of the study, interfere with the subject's participation in the trial or affect the purpose of the trial.
- 23. Those involved in the design and/or implementation of the study.
- 24. Those deemed by the investigator to be unable to comply with the steps, limitations and requirements of the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label, Multicenter, Dose-escalation and Cohort Expansion Phase 1 Clinical Study of ES014 Administered in Patients Locally Advanced or Metastatic Solid Tumours
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.
- Being tested
- ES014
- Keywords
- CD39, TGF-β, CD39xTGF-β
- Medical subject headings
- Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ES014Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| Part 1 dose escalation | Experimental | ES014 doses will be escalated in patients with advanced solid tumors. Receives: 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. Receives: Drug: ES014 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1-3 years
Dose Limiting Toxicity of ES014
Evaluation of dose-limiting toxicity (DLT)
Measured: 1-3 years
Secondary outcomes (9)
Maximum observed serum concentration (Cmax) of ES014
Maximum observed serum concentration (Cmax) of ES014 will be measured.
Measured: 1-3 years
Trough observed serum concentration (Ctrough) of ES014
Trough observed serum concentration (Ctrough)of ES014 will be measured.
Measured: 1-3 years
Area under the serum concentration time curve (AUC) of ES014
Area under the serum concentration time curve (AUC) of ES014 will be measured.
Measured: 1-3 years
Time to Cmax (Tmax) of ES014
Time to Cmax (Tmax) of ES014 will be measured.
Measured: 1-3 years
The terminal elimination half life of ES014
The terminal elimination half-life (t 1/2) of ES014 will be measured.
Measured: 1-3 years
The clearance of ES014
A pharmacokinetic measurement of the volume of plasma from which ES014 is completely removed per unit time.
Measured: 1-3 years
The volume of distribution of ES014
The amount of of ES014 in the body divided by the plasma concentration will be measured.
Measured: 1-3 years
The immunogenicity of ES014
The presence and the frequency of anti-drug antibodies (ADA) against ES014 will be measured.
Measured: 1-3 years
The antitumor activity of ES014
Tumor response will be measured by the revised Response Evaluation Criteria in Solid Tumors version 1.1 (RECISTv1.1) by Investigator assessment.
Measured: 1-3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2023
- Study start24 Feb 2023
- Primary completion28 Feb 2027 (estimated)
- Study completion28 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Elpiscience (Suzhou) Biopharma, Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05717348
- Sponsor's protocol ID
- ES014-1002
- Status last verified
- Oct 2026
- First submitted
- 28 Jan 2023
- Last updated
- 19 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No