Study of Petosemtamab Plus Chemotherapy Versus Cetuximab Plus Chemotherapy in RAS and BRAF Wild-type, Unresectable or Metastatic, Left-sided Colorectal Cancer (LiGeR-CRC1)
2026年9月8日 更新者：Genmab
A Randomized, Open-label, Phase 3 Trial of Petosemtamab in Combination With mFOLFOX6 or FOLFIRI Versus Cetuximab in Combination With mFOLFOX6 or FOLFIRI as First-line Treatment for Participants With RAS and BRAF Wild-type, Unresectable or Metastatic, Left-sided Colorectal Cancer
The purpose of this trial is to evaluate how well petosemtamab in combination with chemotherapy works against colorectal cancer located on the left side of the colon that cannot be safely removed by surgery or has spread to other parts of the body.
Participants will receive either petosemtamab + doctor's choice of chemotherapy (mFOLFOX6 or FOLFIRI) or standard-of-care cetuximab + doctor's choice of chemotherapy (mFOLFOX6 or FOLFIRI). No participants will be given placebo.
The treatment duration will be different for every participant. If a participant's cancer stays the same or gets better, and there are not any serious problems, participants can keep getting study treatment for as long as the study is open.
Participants will be asked to attend 2 visits at the study clinic for each cycle (duration of cycle is 4 weeks). During visits, there will be various tests (such as blood draws) and procedures (such as imaging) to monitor whether the study treatment is safe and effective. The overall study duration (including screening, treatment, and follow-up) will be different for every participant.
研究概览
详细说明
This Phase 3, randomized, open-label, global trial is designed to assess the efficacy and safety of petosemtamab plus investigator's choice (IC) chemotherapy (fluorouracil + leucovorin (calcium folinate) + oxaliplatin [mFOLFOX6] or fluorouracil + leucovorin (calcium folinate) + irinotecan [FOLFIRI]) versus standard of care (SOC) (ie, cetuximab + IC chemotherapy [mFOLFOX6 or FOLFIRI]) as 1L therapy in participants with unresectable or metastatic left-sided colorectal cancer.
研究类型
介入性
注册 (估计的)
960
阶段
- 第三阶段
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Genmab Trial Information
- 电话号码：+4570202728
- 邮箱：clinicaltrials@genmab.com
学习地点
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PR
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Manati、PR、波多黎各、00674
- 招聘中
- PanOncology
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Georgia
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Savannah、Georgia、美国、31405
- 招聘中
- Low Country Cancer Care Associates_Savannah_1
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Warner Robins、Georgia、美国、31088
- 招聘中
- Central Georgia Cancer Care - Warner Robins Office
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Indiana
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Indianapolis、Indiana、美国、46260
- 招聘中
- Hematology-Oncology of Indiana, P.C.
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Missouri
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Springfield、Missouri、美国、65807
- 招聘中
- Oncology Hematology Associates - Springfield_Springfield_2
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Washington
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Olympia、Washington、美国、98502
- 招聘中
- Vista Oncology
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
Key Inclusion Criteria:
- Histologically or cytologically confirmed left-sided colorectal adenocarcinoma that is unresectable or metastatic.
- Must have documented KRAS and NRAS wild type (wt) colorectal cancer (CRC), as determined by medical record of results from local testing or as assessed by central testing. Local testing must have been conducted in accordance with local guidelines using an Food and Drug Administration (FDA)-approved test or a laboratory-developed test that is validated in a Clinical Laboratory Improvement Amendments (CLIA)-certified laboratory (sites in the United States) or an accredited local laboratory (sites outside of the United States). Next-generation sequencing (NGS)-based test results from tumor tissue are required for determining eligibility. Polymerase chain reaction (PCR)-based tests, sanger sequencing, or pyrosequencing test results are not allowed.
- Has not received any prior systemic therapy for unresectable or metastatic CRC.
- Must be eligible for treatment with mFOLFOX6 (if assigned to receive mFOLFOX6) or FOLFIRI (if assigned to receive FOLFIRI) according to local regulatory approvals and SOC guidelines.
Key Exclusion Criteria:
- BRAF mutation, and/or microsatellite instability-high (MSI-H)/deficient mismatch repair (dMMR) and/or protocol specified tumor status as documented by local test results in the medical record or from central testing or known documented activating HRAS mutation identified prior to enrollment from local testing results in the medical record, if available.
- Prior exposure to any agents that target epidermal growth factor receptor (EGFR) (including but not limited to protein products, monoclonal antibodies, tyrosine kinase inhibitors, or antisense oligonucleotide therapy).
- Known complete dihydropyrimidine dehydrogenase (DPD) deficiency or known homozygous/compound heterozygous dihydropyrimidine dehydrogenase gene (DPYD) variants associated with complete loss of DPD activity. Testing for DPD deficiency should be performed per local guidelines.
- For a participant who is to receive FOLFIRI: known to be homozygous for the UGT1A1*28 or *6 alleles or compound or double heterozygous for the UGT1A1*28 and *6 alleles. Testing for UGT1A1 should be done in accordance with local guidelines.
- Participants with non-colorectal adenocarcinomatous disease.
Note: Other protocol-defined Inclusion and Exclusion criteria may apply.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Petosemtamab + IC Chemotherapy
Participants will receive petosemtamab and IC chemotherapy (mFOLFOX6 or FOLFIRI).
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Intravenous infusion
Fluorouracil + leucovorin (calcium folinate) + irinotecan via intravenous infusion.
Fluorouracil + leucovorin (calcium folinate) + oxaliplatin via intravenous infusion.
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有源比较器：Cetuximab + IC Chemotherapy
Participants will receive cetuximab + IC chemotherapy (mFOLFOX6 or FOLFIRI).
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Fluorouracil + leucovorin (calcium folinate) + irinotecan via intravenous infusion.
Fluorouracil + leucovorin (calcium folinate) + oxaliplatin via intravenous infusion.
Intravenous infusion
|
研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
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Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as Assessed by Blinded Independent Central Review (BICR)
大体时间：Up to approximately 35 months
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Up to approximately 35 months
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Objective Response Rate (ORR) per RECIST v1.1 as Assessed by BICR
大体时间：Up to approximately 35 months
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Up to approximately 35 months
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次要结果测量
结果测量 |
大体时间 |
|---|---|
|
Overall Survival (OS)
大体时间：Up to approximately 62 months
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Up to approximately 62 months
|
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Duration of Response (DOR) per RECIST v1.1 as Assessed by BICR
大体时间：Up to approximately 62 months
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Up to approximately 62 months
|
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Disease Control Rate (DCR) per RECIST v1.1 as Assessed by BICR
大体时间：Up to approximately 62 months
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Up to approximately 62 months
|
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Progression-free Survival after First Subsequent Therapy (PFS2)
大体时间：Up to approximately 62 months
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Up to approximately 62 months
|
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Curative Resection (R0) Rate
大体时间：Up to approximately 62 months
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Up to approximately 62 months
|
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Number of Participants with Adverse Events (AEs)
大体时间：Up to approximately 62 months
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Up to approximately 62 months
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Change from Baseline in Symptoms and Functioning, as Measured by European Organisation for Research and Treatment of Cancer (EORTC) Quality-of-life Questionnaire (QLQ)-F17
大体时间：Baseline up to approximately 62 months
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Baseline up to approximately 62 months
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Change from Baseline in Symptoms and Functioning, as Measured by EORTC QLQ-CR29
大体时间：Baseline up to approximately 62 months
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Baseline up to approximately 62 months
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Time to Worsening in Symptoms and Functioning, as Measured by EORTC QLQ-F17
大体时间：Up to approximately 62 months
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Up to approximately 62 months
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Time to Worsening in Symptoms and Functioning, as Measured by EORTC QLQ-CR29
大体时间：Up to approximately 62 months
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Up to approximately 62 months
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Overall Side Effect Burden, as Measured by EORTC Item 168
大体时间：Up to approximately 62 months
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Up to approximately 62 months
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
赞助
调查人员
- 研究主任：Study Official、Genmab
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2026年8月11日
初级完成 (估计的)
2029年7月1日
研究完成 (估计的)
2031年9月1日
研究注册日期
首次提交
2026年7月9日
首先提交符合 QC 标准的
2026年7月9日
首次发布 (实际的)
2026年7月14日
研究记录更新
最后更新发布 (实际的)
2026年9月9日
上次提交的符合 QC 标准的更新
2026年9月8日
最后验证
2026年9月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.