A Study in Adults With Desmoid Tumors

Official title

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

Overview

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.

Interventions

• 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.

Primary outcome measures

• Objective response rate (ORR) by IRC according to RECIST 1.1 [Time frame: 1-3 years]

Secondary outcome measures (8)

• Evaluate the safety and tolerability of ES014 in adult patients with desmoid tumors [Time frame: 1-3 years]
• The efficacy of ES014 in adult patients with desmoid tumors [Time frame: 1-3 years]
• Evaluate the PK of ES014 [Time frame: 1-3 years]
• Evaluate the immunogenicity of ES014 [Time frame: 1-3 years]
• The efficacy of ES014 in adult patients with desmoid tumors [Time frame: 1-3 years]
• The efficacy of ES014 in adult patients with desmoid tumors [Time frame: 1-3 years]
• The efficacy of ES014 in adult patients with desmoid tumors [Time frame: 1-3 years]
• The efficacy of ES014 in adult patients with desmoid tumors [Time frame: 1-3 years]

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:

• 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.
• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Non-randomized

Model

Sequential

Masking

Open label

Primary purpose

Treatment

Study locations

China · 1 center

• Beijing Cancer Hospital — Beijing

Identifiers

NCT: NCT07541430 · ES014-2002

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗