Treatment for adults with desmoid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Beijing Cancer Hospital
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Study coordinator: Jiayu Song
• Email: ClinicalOperation@elpiscience.com
• Phone: (+86) 21 50651310

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Nirogacestat for premenopausal women with desmoid tumors

  This trial tests whether nirogacestat affects ovarian function in premenopausal women (ages 18–40) with progressing desmoid tumors.

  Recruiting at 23 sites Phase 4 Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany · Brussels and 22 other locations · NCT07176689

• Comparing cryoablation and medical therapy for desmoid tumors after watchful waiting

  This study is testing whether cryoablation works better than medical therapy for people with desmoid tumors that have gotten worse after watching them for a while.

  Recruiting at 11 sites University Hospital, Strasbourg, France · Besançon and 12 other locations · NCT06081400

• Treatment of Desmoid Tumors with Nirogacestat and Cryoablation

  This study is testing if a combination of a new oral medication called nirogacestat and a freezing treatment can help people with growing or painful desmoid tumors.

  Recruiting Phase 2 Stanford University · Palo Alto, California · NCT05949099

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.