NCT07541430尚未招募2 期
An Open-Label, Multicenter, Single-Arm Phase 2 Study of ES014 in Adult Subjects With Desmoid Tumors
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Objective response rate (ORR) by IRC according to RECIST 1.1
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1) 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-
- •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.
排除标准
- •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.
研究组 & 干预措施
Part1, Arm 1
Experimental
干预措施: ES014 (Drug)
Part1, Arm 2
Experimental
干预措施: ES014 (Drug)
结局指标
主要结局
Objective response rate (ORR) by IRC according to RECIST 1.1
时间窗: 1-3 years
次要结局
- Evaluate the safety and tolerability 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)
研究者
研究点 (1)
Loading locations...
相似试验
尚未招募
2 期
Neoantigen-Pulsed Autologous Dendritic Cell Vaccine Combined With Temozolomide for Newly Diagnosed GlioblastomaGlioblastomaNCT07365280ZSky Biotech Inc78
招募中
2 期
Andamertinib With or Without Platinum-doublet Chemotherapy Versus Platinum-doublet Chemotherapy in Patients With NSCLC Harboring Atypical EGFR MutationsNCT07336732Avistone Biotechnology Co., Ltd.40
尚未招募
2 期
Phase IIa Study of BRY812 Monotherapy in Advanced Gynecological MalignanciesNCT07311538BioRay Pharmaceutical Co., Ltd.56
尚未招募
2 期
A Phase II Study of Neoadjuvant Sacituzumab Tirumotecan in Combination With Iparomlimab and Tuvonralimab in Locally Advanced Cervical CancerCervical CancerNCT07348861Zheng Min25
招募中
2 期
Phase 2 Study of AHB-137 in HBeAg Negative Chronic Hepatitis B (CHB) Participants in Asia Pacific RegionNCT07370207AusperBio Therapeutics Inc.84