Clinical trial · Interventional
A Study in Adults With Desmoid Tumors
An Open-Label, Multicenter, Single-Arm Phase 2 Study of ES014 in Adult Subjects With Desmoid Tumors
NCT07541430CI-TRIAL-00109903recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Desmoid Tumor | Desmoid Fibromatosis | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ES014 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Part1, Arm 1
- interventionNames
- Drug: ES014
- type
- EXPERIMENTAL
- label
- Part1, Arm 2
- interventionNames
- Drug: ES014
Primary outcomes (1)
- measure
- Objective response rate (ORR) by IRC according to RECIST 1.1
- timeFrame
- 1-3 years
Secondary outcomes (8)
- measure
- Evaluate the safety and tolerability of ES014 in adult patients with desmoid tumors
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: * 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: 1. 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. 2. 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. 3. 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. * 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.
References
Publications (0)
Data not yet available
No reference posted for this study.