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New treatment option for Desmoid Tumor
Official title A Study in Adults With Desmoid Tumors
ClinicalTrials.gov ID: NCT07541430
What this study is testing
What is ES014?
ES014 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for desmoid tumor.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- 3)Meeting any of the following conditions: people with recurrence or disease progression after at least one line of treatment (including surgery...
- 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.
You likely can't join if
- 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...
- For people who have received radiotherapy, a washout period of at least 2 weeks (limb radiation) or 4 weeks (chest, brain, or visceral organ...
- Traditional Chinese medicine (TCM) and proprietary Chinese medicines: if the package insert or investigator deems them to have clear anti-tumor...
See the full eligibility 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: people with recurrence or disease progression after at least one line of treatment (including surgery, radiotherapy, or systemic therapy, etc.); Treatment-naive people who are...
- 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 people of childbearing potential must be willing to completely abstain or agree to use a highly effective method of contraception.
- 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 people 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.