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.
調査の概要
詳細な説明
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.
研究の種類
介入
入学 (推定)
960
段階
- フェーズ 3
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Genmab Trial Information
- 電話番号：+4570202728
- メール：clinicaltrials@genmab.com
研究場所
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Georgia
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Savannah、Georgia、アメリカ、31405
- 募集
- Low Country Cancer Care Associates_Savannah_1
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Warner Robins、Georgia、アメリカ、31088
- 募集
- Central Georgia Cancer Care - Warner Robins Office
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Indiana
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Indianapolis、Indiana、アメリカ、46260
- 募集
- Hematology-Oncology of Indiana, P.C.
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Missouri
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Springfield、Missouri、アメリカ、65807
- 募集
- Oncology Hematology Associates - Springfield_Springfield_2
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Washington
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Olympia、Washington、アメリカ、98502
- 募集
- Vista Oncology
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PR
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Manati、PR、プエルトリコ、00674
- 募集
- PanOncology
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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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アクティブコンパレータ：Cetuximab + IC Chemotherapy
Participants will receive cetuximab + IC chemotherapy (mFOLFOX6 or FOLFIRI).
|
Fluorouracil + leucovorin (calcium folinate) + irinotecan via intravenous infusion.
Fluorouracil + leucovorin (calcium folinate) + oxaliplatin via intravenous infusion.
Intravenous infusion
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
時間枠 |
|---|---|
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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)
時間枠：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
時間枠：Up to approximately 35 months
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Up to approximately 35 months
|
二次結果の測定
結果測定 |
時間枠 |
|---|---|
|
Overall Survival (OS)
時間枠：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
時間枠：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
時間枠：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)
時間枠：Up to approximately 62 months
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Up to approximately 62 months
|
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Curative Resection (R0) Rate
時間枠：Up to approximately 62 months
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Up to approximately 62 months
|
|
Number of Participants with Adverse Events (AEs)
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：Up to approximately 62 months
|
Up to approximately 62 months
|
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Overall Side Effect Burden, as Measured by EORTC Item 168
時間枠：Up to approximately 62 months
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Up to approximately 62 months
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- スタディディレクター：Study Official、Genmab
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2026年8月11日
一次修了 (推定)
2029年7月1日
研究の完了 (推定)
2031年9月1日
試験登録日
最初に提出
2026年7月9日
QC基準を満たした最初の提出物
2026年7月9日
最初の投稿 (実際)
2026年7月14日
学習記録の更新
投稿された最後の更新 (実際)
2026年9月9日
QC基準を満たした最後の更新が送信されました
2026年9月8日
最終確認日
2026年9月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- GCT1158-08
- 2026-525883-17 (その他の識別子：EU CT Number)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
いいえ
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
はい
米国FDA規制機器製品の研究
いいえ
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。