JPRN-jRCT2031230637招募中1 期
A Phase 1 Dose Escalation and Expansion Study of EO-3021, an Anti-claudin 18.2 (CLDN18.2) Antibody Drug Conjugate, in Patients with Solid Tumors Likely to Express CLDN18.2 - ELVCAP-002-01
Jansen Valerie0 个研究点目标入组 40 人开始时间: 2024年2月16日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 ot applicable（—）
- 性别
- All
入选标准
- •Availability of tumor tissue (archived and fresh tumor biopsy, if medically feasible)
- •- Select advanced or metastatic solid tumor that is likely to express CLDN18.2 such as gastric/GEJ, pancreatic and esophageal cancer
- •- >= 18 years of age
- •- ECOG performance status (PS) 0 or 1 at Screening
- •- Progressed on or after standard therapy, or are intolerable for available standard therapy, or there is no available standard therapy
- •- Have at least one measurable extra-cranial lesion as defined by RECIST v1.1
- •- Adequate organ function
- •- Life expectancy > 12 weeks
- •- Ability to understand the nature of this study, comply with protocol requirements, and give written informed consent
- •- Willingness of men and women of reproductive potential to observe conventional and effective birth control for the duration of treatment and for 3 months following study completion
排除标准
- •- Pregnant or breastfeeding
- •- Symptomatic or untreated brain metastases
- •- Have previously received CLDN18.2 antibody drug conjugates (ADCs) or any ADC containing an auristatin payload (prior monoclonal antibody against CLDN18.2 may be eligible)
- •- Have peripheral neuropathy Grade >= 2
- •- Have history of non-infectious pneumonitis/interstitial lung disease
- •- Have diagnosis of another malignancy, or history of systemic treatment for invasive cancer within last 3 years. Note: Patients with Stage I cancer who have received definitive local treatment and are considered unlikely to recur are eligible. Diagnosis of non-melanoma skin cancer, carcinoma in situ of the cervix or breast, or noninvasive tumor does not affect eligibility
- •- Have active ocular surface disease at baseline (based on screening ophthalmic examination)
- •- Have serious concurrent illness or clinically relevant active bacterial, fungal or viral infection
- •- Have previous hypersensitivity to any known components of EO-3021 or history of severe infusion reaction or hypersensitivity (CTCAE Grade 3 or higher) with monoclonal antibody treatment
- •- Clinically significant cardiac disease, including but not limited to symptomatic congestive heart failure, unstable angina, acute myocardial infarction within 6 months of planned first dose, or unstable cardiac arrhythmia requiring therapy (including torsades de pointes)
- •- Have history of allogenic hematopoietic stem cell transplantation or solid organ transplantation with ongoing systemic immunosuppressive therapy
- •- Patients who are not appropriate candidates for participation in this clinical study for any other reason as deemed by the Investigator
研究者
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