A Study in Adults With Desmoid Tumors

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

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.

Study Overview

• Status: Recruiting
• Conditions: Desmoid Tumor
• Intervention / Treatment: Drug: ES014; Drug: ES014

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Jiayu Song; Phone Number: (+86) 21 50651310; Email: ClinicalOperation@elpiscience.com

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100142
      • Recruiting
      • Beijing Cancer Hospital
      • Contact: Lin Shen, Doctor; Phone Number: +86 1088196561; Email: doctorshenlin@sina.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part1, Arm 1	Drug: ES014; ES014 is administered via intravenous infusion, 700mg once every 14 days.; Drug: ES014; ES014 is administered via intravenous infusion, 1400mg once every 14 days.
Experimental: Part1, Arm 2	Drug: ES014; ES014 is administered via intravenous infusion, 700mg once every 14 days.; Drug: ES014; ES014 is administered via intravenous infusion, 1400mg once every 14 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Objective response rate (ORR) by IRC according to RECIST 1.1	1-3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate the safety and tolerability of ES014 in adult patients with desmoid tumors	The assessment is based on the changes in AE, SAE, as well as safety and laboratory evaluation parameters.	1-3 years
Evaluate the PK of ES014	Evaluate based on the PK concentration of ES014	1-3 years
Evaluate the immunogenicity of ES014	By observing the generation process of ADA in ES014 for evaluation	1-3 years
The efficacy of ES014 in adult patients with desmoid tumors	Based on the IRC according to RECIST v1.1, the efficacy of ES014 in adult patients with hard desmoid tumors was assessed.	1-3 years
The efficacy of ES014 in adult patients with desmoid tumors	Based on the DOR evaluated by the researchers , the efficacy of ES014 in adult patients with hard desmoid tumors was assessed.	1-3 years
The efficacy of ES014 in adult patients with desmoid tumors	Based on the DCR by the researchers , the efficacy of ES014 in adult patients with hard desmoid tumors was assessed.	1-3 years
The efficacy of ES014 in adult patients with desmoid tumors	Based on the FPS by the researchers , the efficacy of ES014 in adult patients with hard desmoid tumors was assessed.	1-3 years
The efficacy of ES014 in adult patients with desmoid tumors	Based on the OS by the researchers , the efficacy of ES014 in adult patients with hard desmoid tumors was assessed.	1-3 years

Collaborators and Investigators

• Sponsor: Elpiscience (Suzhou) Biopharma, Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): April 30, 2026
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): October 1, 2028

Study Registration Dates

• First Submitted: March 31, 2026
• First Submitted That Met QC Criteria: April 14, 2026
• First Posted (Actual): April 21, 2026

Study Record Updates

• Last Update Posted (Actual): April 30, 2026
• Last Update Submitted That Met QC Criteria: April 26, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: TGF-β; CD39; CD39xTGF-β
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Neoplasms, Connective and Soft Tissue; Neoplasms, Connective Tissue; Neoplasms, Fibrous Tissue; Fibroma; Desmoid Tumors
• Other Study ID Numbers: ES014-2002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No