Treatment for adults with desmoid tumors

An Open-Label, Multicenter, Single-Arm Phase 2 Study of ES014 in Adult Subjects With Desmoid Tumors

This trial tests ES014 in adults with desmoid tumors to see if it can shrink tumors, relieve tumor-related pain, and is safe and tolerable.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Elpiscience Biopharma, Ltd. (industry)
• Drugs / interventions: chemotherapy, radiation
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT07541430 on ClinicalTrials.gov

What this trial studies

This is an open-label, multicenter, single-arm Phase 2 study giving all enrolled adults ES014 and following them for tumor response, safety, tolerability, and patient-reported outcomes. Key measurements include tumor size by RECIST v1.1, pharmacokinetics, anti-drug antibodies, and pharmacodynamic biomarkers. Eligible participants must have histologically confirmed desmoid tumor with measurable disease and recent progression or uncontrolled tumor-related pain, and meet standard organ-function and performance-status criteria. The study is sponsored by Elpiscience (Suzhou) Biopharma and is being conducted at participating centers including Beijing Cancer Hospital.

Who should consider this trial

Good fit: Adults with histologically confirmed desmoid tumors who have measurable disease and recent tumor growth or uncontrolled tumor-related pain, and who meet organ function and performance-status requirements, are the intended candidates.

Not a fit: Patients with rapidly life-threatening or very fast-progressing disease requiring immediate alternative therapy, those with major organ dysfunction that excludes them from the protocol, or tumors not driven by the drug's targets are unlikely to benefit.

Why it matters

Potential benefit: If successful, ES014 could shrink desmoid tumors, reduce tumor-related pain, and provide a new treatment option for patients.

How similar studies have performed: Targeting CD39 and TGF-β together is a relatively novel approach and there is limited prior clinical evidence of success specifically in desmoid tumors.

Eligibility criteria

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.

Where this trial is running

Beijing, Beijing Municipality

• Beijing Cancer Hospital — Beijing, Beijing Municipality, China (RECRUITING)

Study contacts

• Study coordinator: Jiayu Song

Conditions: Desmoid Tumor, CD39, TGF-β, CD39xTGF-β