Desmoid TumorPhase 2NCT07541430
A Study in Adults With Desmoid Tumors
A Phase 2 study testing ES014 in people with Desmoid Tumor, run by Elpiscience (Suzhou) Biopharma, Ltd. at 1 site in China.
Trial summary
This is an open-label, multicenter, single-arm phase 2 clinical study designed to evaluate the efficacy, safety, tolerability, patient-reported outcomes (PROs), pharmacokinetics (PK), anti-drug antibody (ADA) and pharmacodynamics (PD) of ES014 in adult desmoid tumor patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Desmoid 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
- 50 participants
- Where
- 1 siteChina
- Study dates
- 24 Apr 2026to Oct 2028
- Phase
- Phase 2
- 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) Histologically confirmed desmoid tumor.
- 2)Within 12 months prior to enrollment, meeting any of the following: Tumor target lesion growth ≥ 20% or appearance of new lesions;Desmoid tumor-related pain not adequately controlled by non-opioid medications.
- 3)Meeting any of the following conditions: Subjects with recurrence or disease progression after at least one line of treatment (including surgery, radiotherapy, or systemic therapy, etc.); Treatment-naive subjects who are deemed suitable for the study drug by the investigator.
- 4)Presence of at least one measurable lesion (according to RECIST v1.1).
- 5)Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0-2.
- 6)Life expectancy of at least 12 weeks.
- 7)Adequate hematologic, hepatic, renal and coagulation functions per protocol.
- 8)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 any of the following:
- Anticancer therapy, including chemotherapy, tyrosine kinase inhibitors (TKIs), etc., within 28 days or 5 half-lives (whichever is shorter, but not less than 14 days) prior to the first dose of study drug.
- For subjects who have received radiotherapy, a washout period of at least 2 weeks (limb radiation) or 4 weeks (chest, brain, or visceral organ radiation) is required before the start of study drug administration.
- Traditional Chinese medicine (TCM) and proprietary Chinese medicines: if the package insert or investigator deems them to have clear anti-tumor effects, a 14-day washout is required. Other TCM and proprietary Chinese medicines do not require a washout.
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- 4)Prior allogeneic or autologous bone marrow transplantation or solid organ transplantation.
- 5)Previous treatment-related toxicities unresolved to ≤ Grade 1, with the exception of alopecia (any grade), ≤ Grade 2 peripheral sensory neuropathy, and long-standing irreversible toxicities at the investigator's discretion.
- 6)Major surgery within 4 weeks prior to the first dose of study treatment.
- 7)Live vaccination therapies within 4 weeks prior to the first dose of study treatment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142
Lin Shen, Doctor, +86 1088196561, doctorshenlin@sina.cn
About this study
Official title: An Open-Label, Multicenter, Single-Arm Phase 2 Study of ES014 in Adult Subjects With Desmoid Tumors
This is an open-label, multicenter, single-arm phase 2 clinical study designed to evaluate the efficacy, safety, tolerability, patient-reported outcomes (PROs), pharmacokinetics (PK), anti-drug antibody (ADA) and pharmacodynamics (PD) of ES014 in adult desmoid tumor patients.
- Conditions
- Desmoid Tumor
- Being tested
- ES014
- Keywords
- CD39, TGF-β, CD39xTGF-β
- Medical subject headings
- Desmoid Tumors
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, 700mg once every 14 days.
ES014Drug
ES014 is administered via intravenous infusion, 1400mg once every 14 days.
| Study group | Role | What they receive |
|---|---|---|
| Part1, Arm 1 | Experimental | Not described Receives: Drug: ES014 |
| Part1, Arm 2 | Experimental | Not described Receives: Drug: ES014 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (ORR) by IRC according to RECIST 1.1
Measured: 1-3 years
Secondary outcomes (8)
Evaluate the safety and tolerability of ES014 in adult patients with desmoid tumors
The assessment is based on the changes in AE, SAE, as well as safety and laboratory evaluation parameters.
Measured: 1-3 years
The efficacy of ES014 in adult patients with desmoid tumors
Based on the IRC according to RECIST v1.1, the efficacy of ES014 in adult patients with hard desmoid tumors was assessed.
Measured: 1-3 years
Evaluate the PK of ES014
Evaluate based on the PK concentration of ES014
Measured: 1-3 years
Evaluate the immunogenicity of ES014
By observing the generation process of ADA in ES014 for evaluation
Measured: 1-3 years
The efficacy of ES014 in adult patients with desmoid tumors
Based on the DOR evaluated by the researchers , the efficacy of ES014 in adult patients with hard desmoid tumors was assessed.
Measured: 1-3 years
The efficacy of ES014 in adult patients with desmoid tumors
Based on the DCR by the researchers , the efficacy of ES014 in adult patients with hard desmoid tumors was assessed.
Measured: 1-3 years
The efficacy of ES014 in adult patients with desmoid tumors
Based on the FPS by the researchers , the efficacy of ES014 in adult patients with hard desmoid tumors was assessed.
Measured: 1-3 years
The efficacy of ES014 in adult patients with desmoid tumors
Based on the OS by the researchers , the efficacy of ES014 in adult patients with hard desmoid tumors was assessed.
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 posted21 Apr 2026
- Study start24 Apr 2026
- Primary completionJan 2028 (estimated)
- Study completionOct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Desmoid 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 50 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
- NCT07541430
- Sponsor's protocol ID
- ES014-2002
- Status last verified
- Oct 2026
- First submitted
- 31 Mar 2026
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Multicenter, Single-Arm Phase 2 Study of ES014 in Adult Subjects With Desmoid Tumors
- ClinicalTrials.gov ID
- NCT07541430
- Acronym / sponsor ID
- ES014-2002
- Conditions
- Desmoid Tumor
- Keywords
- CD39, TGF-β, CD39xTGF-β
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Elpiscience (Suzhou) Biopharma, Ltd.Industry (pharma, biotech, devices)
- Study start
- 24 Apr 2026 (actual)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Oct 2028 (estimated)
- First posted
- 21 Apr 2026 (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.
This is an open-label, multicenter, single-arm phase 2 clinical study designed to evaluate the efficacy, safety, tolerability, patient-reported outcomes (PROs), pharmacokinetics (PK), anti-drug antibody (ADA) and pharmacodynamics (PD) of ES014 in adult desmoid tumor patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part1, Arm 1 | Experimental | Drug: ES014 |
| Part1, Arm 2 | Experimental | Drug: ES014 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 1) Histologically confirmed desmoid tumor.
- 2)Within 12 months prior to enrollment, meeting any of the following: Tumor target lesion growth ≥ 20% or appearance of new lesions;Desmoid tumor-related pain not adequately controlled by non-opioid medications.
- 3)Meeting any of the following conditions: Subjects with recurrence or disease progression after at least one line of treatment (including surgery, radiotherapy, or systemic therapy, etc.); Treatment-naive subjects who are deemed suitable for the study drug by the investigator.
- 4)Presence of at least one measurable lesion (according to RECIST v1.1).
- 5)Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0-2.
Key exclusion criteria (10 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 any of the following:
- 4)Prior allogeneic or autologous bone marrow transplantation or solid organ transplantation.
- 5)Previous treatment-related toxicities unresolved to ≤ Grade 1, with the exception of alopecia (any grade), ≤ Grade 2 peripheral sensory neuropathy, and long-standing irreversible toxicities at the investigator's discretion.
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, 700mg once every 14 days. | Drug | Part1, Arm 1 |
| ES014ES014 is administered via intravenous infusion, 1400mg once every 14 days. | Drug | Part1, Arm 2 |
Primary outcome
Objective response rate (ORR) by IRC according to RECIST 1.1
Time frame: 1-3 years
8 secondary outcomes
Evaluate the safety and tolerability of ES014 in adult patients with desmoid tumors
Time frame: 1-3 years
The efficacy of ES014 in adult patients with desmoid tumors
Time frame: 1-3 years
Evaluate the PK of ES014
Time frame: 1-3 years
Evaluate the immunogenicity of ES014
Time frame: 1-3 years
The efficacy of ES014 in adult patients with desmoid tumors
Time frame: 1-3 years
The efficacy of ES014 in adult patients with desmoid tumors
Time frame: 1-3 years
The efficacy of ES014 in adult patients with desmoid tumors
Time frame: 1-3 years
The efficacy of ES014 in adult patients with desmoid tumors
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 21 Oct 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ES014 in people with Desmoid 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 8 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 21 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Contact Jiayu Song ((+86) 21 50651310, ClinicalOperation@elpiscience.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (ORR) by IRC according to RECIST 1.1 (time frame: 1-3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Oct 2026.