NCT07321106招募中1 期
A Phase 1, First-in-human (FIH), Dose-Escalation and Dose-Optimization Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Anti-tumor Activity of CBI-1214 T Cell Engager in Participants With Advanced or Metastatic Microsatellite Stable (MSS)/Microsatellite Instability Low (MSI-L) Colorectal Cancer
Cartography Biosciences10 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2026年1月15日最近更新:
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 10
- 主要终点
- To evaluate the safety and tolerability of CBI-1214 at increasing dose levels and optimized dose levels in participants with advanced or metastatic MSS/MSI-L CRC
研究概览
简要总结
This study will investigate the safety, tolerability, pharmacokinetics, and anti-tumor activity of CBI-1214 in participants with advanced or metastatic Microsatellite Stable (MSS)/Microsatellite Instability Low (MSI-L) Colorectal Cancer
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •The main inclusion criteria include but are not limited to the following:
- •Participant with MSS/MSI-L CRC, who has exhausted at least one prior line of standard systemic therapy for their current malignancy.
- •Participant with genomic aberrations, including but not limited to BRAFV600E mutations and HER2 amplifications, for which FDA-approved targeted therapies are available, must:
- •Have received prior treatment with applicable FDA-approved targeted therapies AND
- •Either have experienced disease progression, be refractory, or be intolerant to directed molecular therapy.
- •Participant able to provide archival tissue sample or fresh biopsy tissue sample
排除标准
- •The main exclusion criteria include but are not limited to the following:
- •Participant whose CRC tumor tissues have been identified as dMMR or MSI-H
- •Known history of solid organ or tissue transplant; history of interstitial lung disease or non-infectious pneumonitis.
- •Untreated central nervous system (CNS) metastatic disease.
- •Active autoimmune disease that has required systemic treatment within the past 2 years (participants with hormone replacement therapy for adequately controlled endocrinopathy are allowed in the study).
- •History of recent infection (within 4 weeks of C1D1) considered to be caused by one of the pathogens: HSV1, HSV2, VZV, EBV, CMV, measles, Influenza A, Zika virus, Chikungunya virus, mycoplasma pneumonia, Campylobacter jejuni, or enterovirus D
- •Known seropositive for human immunodeficiency virus, hepatitis B surface antigen, or antibody to hepatitis C virus with confirmatory testing and requiring anti-viral therapy.
- •History of Steven's Johnson's syndrome or toxic epidermal necrolysis syndrome.
- •Significant medical comorbidities, including uncontrolled hypertension (diastolic blood pressure >115 mm Hg), unstable angina, congestive heart failure (greater than New York Heart Association class II), severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia, poorly controlled diabetes, severe chronic pulmonary disease, coronary angioplasty, or myocardial infarction within 6 months prior to screening, or uncontrolled atrial or ventricular cardiac arrhythmias.
- •Congenital long QT syndrome or a corrected QT interval (QTc) ≥480 ms at screening (unless secondary to pacemaker or bundle branch block).
- •Active second primary malignancy within 3 years of Screening other than non-melanoma skin cancers, nonmetastatic prostate cancer, in situ cervical cancer, or ductal or lobular carcinoma in situ of the breast
研究组 & 干预措施
Dose escalation and optimization trial of CBI-1214
Experimental
Participants will be assigned sequentially to escalating doses of CBI-1214. Once dose escalation is completed, a recommended expansion dose will be proposed for the dose-expansion stage of the trial.
干预措施: CBI-1214 (Biological)
结局指标
主要结局
To evaluate the safety and tolerability of CBI-1214 at increasing dose levels and optimized dose levels in participants with advanced or metastatic MSS/MSI-L CRC
时间窗: Approximately 48 months
Incidence and severity of TEAEs, TRAEs, and TESAEs; changes in vital signs, physical examinations, and clinical laboratory parameters per NCI-CTCAE v5.0.
To determine the MTD and/or OBD and select the recommended dose(s) of CBI-1214 for dose optimization
时间窗: Approximately 48 months
Incidence of DLTs observed during the first treatment cycle
次要结局
- Overall Survival (OS)(Approximately 48 months)
- To characterize the Serum Concentration of CBI-1214.(Approximately 48 months)
- Overall Response Rate (ORR)(Approximately 48 months)
- Duration of Response (DOR)(Approximately 48 months)
- Time to Response (TTR)(Approximately 48 months)
- Progression Free Survival (PFS)(Approximately 48 months)
- Clinical Benefit Rate (CBR)(Approximately 48 months)
研究者
研究点 (10)
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