NCT07823322尚未招募2 期
A Phase 2 Study of INCA33890 in the Treatment of Circulating Tumor DNA-Positive Stage II/III Microsatellite Stable Colorectal Cancer After Curative Resection and Chemotherapy (NEXERA-204)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 40
- 主要终点
- Circulating tumor DNA (ctDNA) clearance
研究概览
简要总结
The purpose of this study is to evaluate INCA33890 in the treatment of circulating tumor DNA-positive stage II/III microsatellite stable colorectal cancer after curative resection and chemotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Received curative-intent (R0) resection of histologically confirmed Stage II or III colorectal adenocarcinoma.
- •Completed all neoadjuvant and/or adjuvant chemotherapy, including at least 3 months of fluoropyrimidine-based chemotherapy.
- •Has minimal residual disease (MRD), defined as ctDNA positive by the Signatera™ assay (whole exome sequencing [WES] or whole genome sequencing [WGS]) in a blood sample collected between:
- •2 weeks and 12 months after completion of adjuvant chemotherapy or
- •4 weeks and 12 months after curative resection following total neoadjuvant therapy.
- •Note: If the participant received any investigational therapy for MRD, ctDNA positivity must be confirmed in a blood sample collected at least 4 weeks after completion of that investigational therapy and within the applicable 12-month window described above.
- •Has no clinical or radiographic evidence of disease confirmed by chest, abdominal, and pelvic PET-CT scan and by brain imaging (MRI or CT scan with contrast) within 4 weeks prior to C1D1 study drug administration.
- •ECOG performance status of 0 or
- •Adequate organ function determined by laboratory results.
排除标准
- •History of metastatic (Stage IV) colorectal adenocarcinoma, including oligometastatic disease or metastatic recurrence, even if all metastatic sites and the primary tumor were completely resected and the patient is currently without evidence of disease.
- •MSI-H/dMMR per historical data in the medical record.
- •History of other malignancy within 2 years.
- •Treatment with an anti-PD-(L)1 or anti-CTLA-4 for any indication within the last 3 years.
- •Active autoimmune disease that has required systemic treatment in the past 2 years.
- •Significant concurrent and/or uncontrolled medical condition.
- •History of organ transplant, including allogeneic stem cell transplantation.
- •Other protocol-defined inclusion/exclusion criteria apply.
研究组 & 干预措施
INCA33890
Experimental
INCA33890 will be administered at the protocol-defined dose.
干预措施: INCA33890 (Drug)
结局指标
主要结局
Circulating tumor DNA (ctDNA) clearance
时间窗: 3 months
Defined as ctDNA positive at baseline and change to ctDNA negative at 3 months.
次要结局
- ctDNA clearance by visit(Up to approximately 19 months)
- Absolute change from baseline in ctDNA levels at each visit(Up to approximately 19 months)
- Percent change from baseline in ctDNA levels at each visit(Up to approximately 19 months)
- Disease-free survival (DFS)(Up to approximately 19 months)
- Treatment Emergent Adverse Events (TEAEs)(Up to approximately 19 months)
- TEAEs leading to dose interruptions, dose delays or discontinuation of study treatment(Up to approximately 19 months)
研究者
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