Actively Recruiting
An Open-Label, Multicenter, Single-Arm Phase 2 Study of ES014 in Adult Subjects With Desmoid Tumors
Led by Elpiscience (Suzhou) Biopharma, Ltd. · Updated on 2026-04-30
50
Participants Needed
1
Research Sites
39 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the drug ES014 in adults with desmoid tumors in this open-label, multicenter, single-arm phase 2 clinical study. The study aims to assess the effectiveness, safety, tolerability, patient-reported outcomes, pharmacokinetics, pharmacodynamics, and immune response to ES014 in this patient population. Participants will receive ES014 through intravenous infusion at doses of either 700 mg or 1400 mg every 14 days. The study design includes two experimental arms with these dosing regimens. Treatment will be given over a period of 1 to 3 years while monitoring the patients closely for response and side effects. During the study, participants will undergo evaluations including tumor response assessments according to RECIST 1.1 criteria, safety and tolerability checks, pharmacokinetic testing, and immune response measurements. Researchers will track patient-reported outcomes and monitor for adverse effects throughout the study duration. The primary outcome is the objective response rate measured by an independent review committee over 1 to 3 years.
CONDITIONS
Brief Title
A Study in Adults With Desmoid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed desmoid tumor.
- Within 12 months prior to enrollment, tumor target lesion growth of 20% or more or appearance of new lesions, or desmoid tumor-related pain not controlled by non-opioid medications.
- Either recurrence or progression after at least one treatment, or treatment-naive and suitable for the study drug.
- At least one measurable lesion according to RECIST v1.1.
- ECOG Performance Status score of 0 to 2.
- Life expectancy of at least 12 weeks.
- Adequate blood, liver, kidney, and clotting function as defined by the protocol.
- Male and female subjects of childbearing potential must agree to abstain or use effective contraception.
You will not qualify if you...
- Prior therapy targeting CD39, CD73, adenosine A2A receptor, or TGF-β.
- Receipt of investigational agents or devices within 4 weeks before first dose.
- Recent anticancer therapy within 28 days or 5 half-lives, whichever is shorter, but not less than 14 days.
- Recent radiotherapy with required washout periods.
- Use of certain traditional Chinese medicines with anti-tumor effects within 14 days.
- Prior bone marrow or solid organ transplantation.
- Unresolved treatment-related toxicities above specified grades, except certain exceptions.
- Major surgery within 4 weeks before first dose.
- Live vaccination therapies within 4 weeks before first dose.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 3 years
Participants receive ES014 via intravenous infusion every 14 days as part of the study treatment for desmoid tumors.
Visits every 2 weeks for infusions
Trial Site Locations
Total: 1 location
1
Beijing Cancer Hospital
Beijing, Beijing Municipality, China, 100142
Actively Recruiting
Research Team
J
Jiayu Song
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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