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.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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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
Are there results?: Not yet: the study is under way

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.

China1 site

Shanghai Chest Hospital
Shanghai

Other trials in China

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

Conditions: Solid Tumor, Locally Advanced Solid Tumor, Metastatic Solid Tumor
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 groups in NCT05717348
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.

24 Feb 202328 Feb 2027

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)

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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
Active, not recruitingPhase 3
A Safety and Efficacy Extension Study of Pertuzumab in Patients With Solid Tumors Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Clinical Trial
Solid Tumors
RecruitingPhase 1
IL-12 Genetically Engineered Myeloid Cells in Participants With Relapsed, Refractory Solid Tumors
Relapsed Solid Tumor Malignancies, Refractory Solid Tumor Malignancies
RecruitingObservational study
Immune Checkpoint Inhibitor Toxicity Risk Prediction in Solid Tumors
Malignant Solid Neoplasm

All Solid Tumor trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT05717348
Acronym / sponsor ID: ES014-1002
Conditions: Solid Tumor, Locally Advanced Solid Tumor, Metastatic Solid Tumor
Keywords: CD39, TGF-β, CD39xTGF-β
Phase: Phase 1
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 120 participants (estimated)
Lead sponsor: Elpiscience (Suzhou) Biopharma, Ltd.Industry (pharma, biotech, devices)
Study start: 24 Feb 2023 (actual)
Primary completion: 28 Feb 2027 (estimated)
Study completion: 28 Feb 2027 (estimated)
First posted: 8 Feb 2023 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Part 1 dose escalation	Experimental	Drug: ES014ES014 doses will be escalated in patients with advanced solid tumors.
Part 2 dose expansion	Experimental	Drug: ES014Part 2 of the study will consist of 4 expansion cohorts at the recommended optimal biological dose determined in Part 1 dose escalation.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

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.

Key exclusion criteria (24 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ES014ES014 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.	Drug	Part 1 dose escalation, Part 2 dose expansion

Primary outcome

The frequency and severity of adverse events of ES014
Time frame: 1-3 years
Adverse events will be assessed and assigned by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 5.0.
Dose Limiting Toxicity of ES014
Time frame: 1-3 years
Evaluation of dose-limiting toxicity (DLT)

9 secondary outcomes

Maximum observed serum concentration (Cmax) of ES014
Time frame: 1-3 years
Trough observed serum concentration (Ctrough) of ES014
Time frame: 1-3 years
Area under the serum concentration time curve (AUC) of ES014
Time frame: 1-3 years
Time to Cmax (Tmax) of ES014
Time frame: 1-3 years
The terminal elimination half life of ES014
Time frame: 1-3 years
The clearance of ES014
Time frame: 1-3 years
The volume of distribution of ES014
Time frame: 1-3 years
The immunogenicity of ES014
Time frame: 1-3 years
The antitumor activity of ES014
Time frame: 1-3 years

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2026.
Individual participant dataSharing planned: No

Related trials for Solid Tumor

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
Active, not recruitingPhase 3
A Safety and Efficacy Extension Study of Pertuzumab in Patients With Solid Tumors Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Clinical Trial
Solid Tumors
RecruitingPhase 1
IL-12 Genetically Engineered Myeloid Cells in Participants With Relapsed, Refractory Solid Tumors
Relapsed Solid Tumor Malignancies, Refractory Solid Tumor Malignancies
RecruitingObservational study
Immune Checkpoint Inhibitor Toxicity Risk Prediction in Solid Tumors
Malignant Solid Neoplasm

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The frequency and severity of adverse events of ES014 (time frame: 1-3 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05717348.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2026.