NL-OMON47296已完成不适用
A phase 1 dose escalation and cohort expansion study of ERY974, an anti-Glypican 3 (GPC3)/CD3 bispecific antibody, in patients with advanced solid tumor - Chugai101EG
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
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
- 18 至 99（—）
入选标准
- •Key Inclusion Criteria:
- •* Histologically confirmed and measurable malignant solid tumor and/or metastatic disease not amenable to standard therapy or for which standard therapy is not available or not indicated
- •* GPC3 positive tumor by immunohistochemistry (IHC) on a biopsy sample *18 months old at the time of IHC analysis
- •* Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1
- •* Adequate hematological, hepatic, renal, coagulation and nutritional status
- •* For female patients of child-bearing potential a negative serum pregnancy test
- •* Life expectancy *3 months.
- •Inclusion Criteria Unique to Cohort Expansion:
- •* Cohort A: GPC3 positive and histologically confirmed gastric or GEJ adenocarcinoma
- •* Cohort B: GPC3 positive and histologically confirmed head and neck squamous cell carcinoma
- •* Cohort C: GPC3 positive and histologically confirmed sarcoma
- •* Cohort D: Any other GPC3 positive solid tumor that is advanced and/or metastatic and either not amenable to standard therapy or for which standard therapy is not available or not indicated
- •o The cut-off value for GPC3 expression in each of the cohort expansion groups may be determined based on data generated in the dose escalation part of the study. These cut-off values will be communicated, in writing, to each site prior to initiation of cohort expansion.
排除标准
- •Key Exclusion Criteria:
- •* Patients with more than a single brain metastasis, a single brain metastasis > 1 cm in size, or a single brain metastasis *1 cm size but not stable for 4 weeks or longer
- •* Current or previous interstitial lung disease evident on imaging
- •* Requirement of regular drainage of ascites and/or pleural effusion
- •* Treatment with monoclonal antibodies (except for denosumab) or other immunotherapy within 28 days prior to first receipt of study drug
- •* Prior treatment with other excluded therapies
- •* Patients with clinically significant (as determined by the investigator) acute or chronic infection or infection occurring during the 14 days prior to first receipt of study drug
- •* Patients with known human immunodeficiency virus
- •* Hepatitis B virus (HBV) surface antigen, HBV core antibody and hepatitis C (HCV) core antibody will be tested at screening. Patients with active (HBV, and/or active HCV infection or any other known active virus infection considered to be clinically relevant by the investigator.
- •* Major surgery within 28 days prior to first receipt of study drug
- •* Patients with allergic reactions attributed to components of the formulated study drug, corticosteroids or anti-histamines
- •* Patients with another invasive malignancy in the last 2 years (with the exception of basal cell carcinoma and tumors deemed by the investigator to have a low likelihood for recurrence).
- •Exclusion Criteria Unique to Dose Escalation
- •* Subjects with histologically confirmed lung cancer and hepatocellular carcinoma (HCC) will be excluded from the fixed dose cohorts. These subjects can be enrolled into the individual dose titration cohort.
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