NL-OMON48866已完成不适用
An Open-Label, Dose Escalation, Phase 1, First-in-Human Study of TAK-164, an Antibody-Drug Conjugate, in Patients with Advanced Gastrointestinal Cancers Expressing Guanylyl Cyclase C - Research of TAK-164 in patients with gastrointestinal cancers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
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
- •* Histologically or cytologically confirmed measurable advanced and/or
- •metastatic solid GI tumor that expresses GCC protein (H-score *10), for which
- •standard treatment is no longer effective or for whom there is no available
- •standard therapy. For the escalation part of the study (part A), GI
- •malignancies include, but are not limited to, mCRC, gastric carcinoma,
- •esophageal carcinoma, small intestine cancer, and pancreatic cancer. The
- •expansion part of the study (part B) is limited to patients with CRC expressing
- •a high-level GCC (H-score *150) and gastric carcinoma expressing GCC (H-score
- •*10). Part C includes patients with CRC and gastric carcinoma expressing GCC
- •(H-score *10).
- •* The expansion part of the study (part B) will be limited to patients with 2
- •or 3 prior lines of systemic
- •standard of care therapy.
- •* Voluntary written consent must be obtained from the patient prior to
- •enrollment in the study with the understanding that consent may be withdrawn by
- •the patient at any time without consequences on receiving future medical care.
- •* Male or female patients 18 years or older.
- •* Adequate bone marrow function, defined as an absolute neutrophil count of
- •*1.5 × 109/L, platelet count *100 × 109/L, and hemoglobin *9 g/dL. Receiving
- •transfusions or hematopoietic growth factors to meet enrollment criteria are
- •not allowed within 14 days preceding the first dose of study drug.
- •* Adequate hepatic function with:
- •* Total bilirubin *1.5 * upper limit of normal (ULN).
- •* Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST)
- •must be *2.5 * ULN (AST and ALT may be elevated up to 3 * ULN if the elevation
- •can be reasonably ascribed to the presence of metastatic disease in liver).
- •* Serum albumin *3.0 g/dL.
- •* Adequate renal function as defined by creatinine clearance *60 mL/min.
- •* Eastern Cooperative Oncology Group performance score of 0 or 1.
- •* Life expectancy of at least 12 weeks.
- •* Completion of prior chemotherapy, biologic therapy, immunotherapy, or
- •radiation therapy at least 4 weeks prior to enrollment.
- •* Resolution of all toxic effects of prior treatments (except alopecia) to
- •Grade *1 by National Cancer Institute
- •Common Terminology Criteria for Adverse Events, version 5.
- •* A portion of patients should have tumors amendable for serial biopsy and a
- •willingness to provide consent for pharmacodynamic assessment.
- •Additionally, for part C (imaging substudy), patients must fulfill the
- •following criteria:
- •* At least 1 extrahepatic metastatic lesion *2 cm in the longest diameter.
排除标准
- •* Female patients who are lactating and breastfeeding or have a positive serum
- •pregnancy test during the screening period, or male or female patients of
- •reproductive potential who are not employing an effective method of birth
- •* Serious preexisting medical or psychiatric conditions that, in the opinion of
- •the investigator, would preclude participation in the study.
- •* Chronic or active infection requiring systemic therapy, as well as a history
- •of symptomatic viral infection which has not been fully cured (eg, HIV or viral
- •hepatitis B or C).
- •* Symptomatic central nervous system (CNS) malignancy or metastasis. Screening
- •of asymptomatic patients without history of CNS metastases is not required.
- •* History of congestive heart failure with New York Heart Association class
- •greater than 2 (Class 1 and 2 are eligible), unstable angina (within 3 months
- •prior to study enrollment), recent myocardial infarction (within 6 months of
- •study enrollment), transient ischemic attacks, stroke, arterial or venous
- •vascular disease, or clinically significant symptomatic arrhythmia despite
- •anti-arrhythmic therapy.
- •* Corrected QT by Fridericia method interval >470 msec.
- •* Treatment with anticancer chemotherapy or biologic therapy or with an
- •experimental anticancer agent within 28 days of the initial dose of study drug.
- •* Patient has a history of severe allergic or anaphylactic reactions to
- •recombinant proteins or excipients used in TAK-164 or 89Zr-TAK-164 formulation.
- •* Patient has concurrent alcohol abuse or a history of drug-induced liver
- •injury (DILI).
研究者
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