Desmoid Tumor
Conditions
Keywords
CD39, TGF-β, CD39xTGF-β
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.
Interventions
DRUGES014
ES014 is administered via intravenous infusion, 700mg once every 14 days.
Sponsors
Elpiscience (Suzhou) Biopharma, Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate (ORR) by IRC according to RECIST 1.1 | 1-3 years |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate the safety and tolerability of ES014 in adult patients with desmoid tumors | 1-3 years | The assessment is based on the changes in AE, SAE, as well as safety and laboratory evaluation parameters. |
| The efficacy of ES014 in adult patients with desmoid tumors | 1-3 years | Based on the IRC according to RECIST v1.1, the efficacy of ES014 in adult patients with hard desmoid tumors was assessed. |
| Evaluate the PK of ES014 | 1-3 years | Evaluate based on the PK concentration of ES014 |
| Evaluate the immunogenicity of ES014 | 1-3 years | By observing the generation process of ADA in ES014 for evaluation |
Countries
China
Contacts
CONTACTJiayu Song
Outcome results
None listed