jRCT2041260049尚未招募不适用
A Phase 1 Study of JNJ-89402638 for Unresectable Metastatic Colorectal Cancer and Other Gastrointestinal Malignancies
未提供0 个研究点目标入组 260 人开始时间: 待定
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 260
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
入排标准
- 年龄范围
- 18age old over 至 No limit（—）
- 性别
- All
入选标准
- •For Part 1 (dose escalation), Part 2 (Arm A [JNJ-89402638 monotherapy]):
- •Have histologically or cytologically confirmed diagnosis of colorectal adenocarcinoma (CRC) progressing after 2 or more prior lines of standard therapy in the metastatic/unresectable setting;
- •For Part 2 Arm B (JNJ-89402638 + bevacizumab or biosimilar):
- •Have histologically or cytologically confirmed diagnosis of CRC progressing after 2 or more prior lines of standard therapy in the metastatic/unresectable setting;
- •For Part 2 Arm C (JNJ-89402638 + FOLFOX/bevacizumab or biosimilar):
- •Have histologically or cytologically confirmed diagnosis of microsatellite stable (MSS) or proficient mismatch repair (pMMR) CRC progressing after 1 or more prior line of standard therapy in the metastatic/unresectable setting. Must not have received oxaliplatin previously for metastatic disease;
- •For Part 2 Arm D (JNJ-89402638 + FOLFIRI/bevacizumab or biosimilar):
- •Have histologically or cytologically confirmed diagnosis of MSS or pMMR CRC progressing after 1 prior line of standard therapy in the metastatic/unresectable setting. Must not have received irinotecan previously for metastatic disease;
- •For Part 2 Arm E (JNJ-89402638 monotherapy in mGAC): Have histologically or cytologically confirmed diagnosis of gastric adenocarcinoma or gastroesophageal junction adenocarcinoma progressing after 1 or more prior lines of standard therapy in the metastatic/unresectable setting
- •Have evaluable or measurable disease per response evaluation criteria in solid tumors (RECIST) version 1.1
- •(a) Part 1: Must have either measurable or evaluable disease
- •(b) Part 2: Must have at least 1 measurable lesion
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
- •Have an estimated or measured glomerular filtration rate (GFR) greater than or equal to (>=) 30 milliliter per minute (mL/min) based on modification of diet in renal disease (MDRD) 4-variable formula
排除标准
- •Active (new or progressive) brain metastases, leptomeningeal disease, or untreated spinal cord compression
- •Toxicity from prior anticancer therapy that has not resolved to Grade less than or equal to (<=)1 (except alopecia, vitiligo, Grade <= 2 peripheral neuropathy,or endocrinopathies that are stable on hormone replacement). For Part 2 Arm C:Grade 2 or higher peripheral neuropathy is considered exclusionary
- •Has a prior or concurrent second malignancy (other than the disease under study) unless natural history or treatment is unlikely to interfere with any study endpoints of safety or the efficacy of the study treatment
- •Received glucocorticoids (doses >10 mg/day prednisone or equivalent) within 7 days prior to the first dose of study drug
- •Received or plans to receive any live, attenuated vaccine within 4 weeks before the first dose of study treatment or within 4 weeks after the last dose of study treatment
研究者
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