NCT07541430

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for phase_2

Timeline
30mo left

Started Apr 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress1%
Apr 2026Oct 2028

First Submitted

Initial submission to the registry

March 31, 2026

Completed
21 days until next milestone

First Posted

Study publicly available on registry

April 21, 2026

Completed
9 days until next milestone

Study Start

First participant enrolled

April 30, 2026

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2028

Expected
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2028

Last Updated

April 30, 2026

Status Verified

April 1, 2026

Enrollment Period

1.7 years

First QC Date

March 31, 2026

Last Update Submit

April 26, 2026

Conditions

Desmoid Tumor

Keywords

CD39TGF-βCD39xTGF-β

Outcome Measures

Primary Outcomes (1)

  • Objective response rate (ORR) by IRC according to RECIST 1.1

    1-3 years

Secondary Outcomes (8)

  • Evaluate the safety and tolerability of ES014 in adult patients with desmoid tumors

    1-3 years

  • The efficacy of ES014 in adult patients with desmoid tumors

    1-3 years

  • Evaluate the PK of ES014

    1-3 years

  • Evaluate the immunogenicity of ES014

    1-3 years

  • The efficacy of ES014 in adult patients with desmoid tumors

    1-3 years

  • +3 more secondary outcomes

Study Arms (2)

Part1, Arm 1

EXPERIMENTAL
Drug: ES014

Part1, Arm 2

EXPERIMENTAL
Drug: ES014

Interventions

ES014DRUG

ES014 is administered via intravenous infusion, 700mg once every 14 days.

Part1, Arm 1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \) Histologically confirmed desmoid tumor.
  • )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.
  • )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.
  • )Presence of at least one measurable lesion (according to RECIST v1.1).
  • )Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0-2.
  • )Life expectancy of at least 12 weeks.
  • )Adequate hematologic, hepatic, renal and coagulation functions per protocol.
  • )Male and female subjects of childbearing potential must be willing to completely abstain or agree to use a highly effective method of contraception.

You may not qualify if:

  • )Any prior therapy targeting CD39, CD73, adenosine A2A receptor, or TGF-β.
  • )Receipt of any investigational agents or devices within 4 weeks prior to the first dose of study drug.
  • )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 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.
  • 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.
  • )Prior allogeneic or autologous bone marrow transplantation or solid organ transplantation.
  • )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.
  • )Major surgery within 4 weeks prior to the first dose of study treatment.
  • )Live vaccination therapies within 4 weeks prior to the first dose of study treatment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

RECRUITING

MeSH Terms

Conditions

Desmoid Tumors

Condition Hierarchy (Ancestors)

FibromaNeoplasms, Fibrous TissueNeoplasms, Connective TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasms

Central Study Contacts

Jiayu Song

CONTACT

(+86) 21 50651310ClinicalOperation@elpiscience.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 31, 2026

First Posted

April 21, 2026

Study Start

April 30, 2026

Primary Completion (Estimated)

January 1, 2028

Study Completion (Estimated)

October 1, 2028

Last Updated

April 30, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)