難治性マイクロサテライト安定転移性結腸直腸癌に対するセツキシマブおよびペムブロリズマブによるALX148の研究
2026年8月12日 更新者：University of Colorado, Denver
難治性マイクロサテライト安定転移性結腸直腸癌患者における ALX148 とセツキシマブおよびペムブロリズマブの併用の第 II 相試験（安全性の導入を伴う）
この第 2 相臨床試験では、ALX148 をセツキシマブおよびペムブロリズマブと併用して、難治性マイクロサテライト安定転移性結腸直腸癌に対して評価します
調査の概要
詳細な説明
これは、少なくとも 2 日間進行した転移性マイクロサテライト安定型結腸直腸癌患者を対象に、ALX148、セツキシマブ、ペムブロリズマブの併用を評価する非盲検、多施設共同、単群第 II 相臨床試験 (安全性の導入を伴う) です。全身療法のライン。
患者のサブセットは、研究関連の生検を受けます。
安全な慣らし段階があり、その後に用量拡大段階が続きます。
両方の段階の患者は、RECIST v1.1に従って疾患が進行するまで研究療法を受け続けます。
研究の種類
介入
入学 (実際)
19
段階
- フェーズ2
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。
研究場所
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Arizona
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Tucson、Arizona、アメリカ、85724
- University of Arizona Cancer Center
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Colorado
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Aurora、Colorado、アメリカ、80045
- University Of Colorado Cancer Center
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New Jersey
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New Brunswick、New Jersey、アメリカ、08903
- Rutgers Cancer insititute
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Virginia
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Fairfax、Virginia、アメリカ、22031
- Inova Schar Cancer Institute
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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
18年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
説明
包含基準:
この研究に参加する資格を得るには、個人は次の基準をすべて満たす必要があります。
- -切除不能/転移性疾患に対する少なくとも2つの治療法で以前に治療された転移性結腸直腸癌の診断を受けている
- マイクロサテライト安定疾患を有する
- -適切な血液学的機能および末端臓器機能
除外基準:
以下の基準のいずれかを満たす個人は、この研究への参加から除外されます。
- -既知のMSI-highステータスまたは既知のミスマッチ修復欠損症（dMMR）の患者
- ミスマッチ修復とマイクロサテライト安定状態の両方が不明な患者
- -重度のアレルギー、アナフィラキシー、またはその他の過敏反応の病歴 治験薬またはそのクラスのいずれか
- EGFR阻害剤未投与の左側（脾屈曲部またはその遠位）RAS/BRAF野生型転移性結腸直腸がん。
- -抗PD-1、抗PD-L1、抗PD L2、抗CD47、または抗SIRPα剤、または別の刺激性または共抑制性T細胞受容体（例、CTLA- 4、OX 40、CD137)
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：非ランダム化
- 介入モデル：順次割り当て
- 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：Stage 1: Safety run-in evaluating evorpacept at 15 mg/kg weekly
Doses:
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IV QW
他の名前：
IV Q3W
他の名前：
IV QW
他の名前：
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実験的：Stage 1: Safety run-in evaluating evorpacept at 10 mg/kg weekly
Doses:
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IV QW
他の名前：
IV Q3W
他の名前：
IV QW
他の名前：
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実験的：Stage 2: Expansion cohort using recommended dose (RD) of evorpacept
Doses:
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IV QW
他の名前：
IV Q3W
他の名前：
IV QW
他の名前：
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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 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Objective Response Rate (ORR)
時間枠：The duration of time during which tumor assessments were performed for each individual patient. Per protocol, assessments will continue until disease progression. The latest assessment was performed at Cycle 21, Day 15 (14.5 mo after informed consent)
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A patient is considered to be an objective responder if their best overall response (BOR) of their follow-up tumor assessments was assessed to be complete response (CR) or partial response (PR) per RECIST v1.1.
ORR is defined as the proportion of patients who were classified as objective responders.
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The duration of time during which tumor assessments were performed for each individual patient. Per protocol, assessments will continue until disease progression. The latest assessment was performed at Cycle 21, Day 15 (14.5 mo after informed consent)
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Determine the Recommended Dose (RD) of Evorpacept (ALX148) in Combination With Cetuximab and Pembrolizumab
時間枠：During the safety run-in, each patient must have completed at least the 1st cycle (3 weeks) of treatment.
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The recommended dose (RD) of evorpacept was determined by evaluating the totality of the first-cycle clinical data.
Rules to determine the RD based on the number of patients experiencing a dose-limiting toxicity (DLT) were defined in the protocol.
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During the safety run-in, each patient must have completed at least the 1st cycle (3 weeks) of treatment.
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Duration Of Response (DOR)
時間枠：From date of 1st response (CR or PR) until either progression (PD or death) or censoring date
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DOR is defined as the length of time (months) from the 1st response (CR or PR per RECIST v1.1) until either the first observation of progressive disease (PD) or death from any cause.
Patients who did not experience PD or die are considered to be censored at the latest date they are confirmed to be alive, which is the most recent of their discontinuation date or latest follow-up date.
This is a subgroup analysis, consisting of all patients who experienced response (CR or PR per RECIST v1.1)
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From date of 1st response (CR or PR) until either progression (PD or death) or censoring date
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Progression-Free Survival (PFS)
時間枠：For each subject, from enrollment until the end of their months-to-progression (as defined above)
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Months-to-Progression is defined as the length of time (in months) from enrollment until either the first observation of progressive disease (PD) using RECIST v1.1 or death from any cause.
Patients who did not have PD or die will be considered to be censored at the latest date they are confirmed to be alive, which is the most recent of their discontinuation date or latest follow-up date.
PFS is a survival analysis involving both the binary endpoint of whether or not each patient progressed or not (i.e. were censored), and the months-to-progression times for each patient.
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For each subject, from enrollment until the end of their months-to-progression (as defined above)
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Overall Survival (OS)
時間枠：For each subject, from enrollment until the end of their months-to-death time (as defined above)
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Months-to-death is defined as the number of months from enrollment until death from any cause.
Subjects who did not die will be considered to be censored at the latest date they are confirmed to be alive, which is the most recent of their discontinuation date or latest follow-up date.
OS is a survival analysis involving both the binary endpoint of whether or not each patient died or not, and the months-to-death times for each patient.
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For each subject, from enrollment until the end of their months-to-death time (as defined above)
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Disease Control Rate (DCR)
時間枠：The duration of time during which tumor assessments were performed for each individual patient. Per protocol, assessments will continue until disease progression. The latest assessment was performed at Cycle 21, Day 15 (14.5 mo after informed consent).
|
A patient is classified as 'Disease Controlled' if their best overall response (BOR) of their follow-up tumor assessments was assessed to be complete response (CR), partial response (PR), or stable disease (SD) per RECIST v1.1.
DCR is defined as the proportion of patients who were classified as 'Disease Controlled'.
|
The duration of time during which tumor assessments were performed for each individual patient. Per protocol, assessments will continue until disease progression. The latest assessment was performed at Cycle 21, Day 15 (14.5 mo after informed consent).
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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PFS - Response-Evaluable Population
時間枠：For each subject, from enrollment until the end of their months-to-progression (as defined above)
|
Months-to-Progression is defined as the length of time (in months) from enrollment until either the first observation of progressive disease (PD) using RECIST v1.1 or death from any cause.
Patients who did not have PD or die will be considered to be censored at the latest date they are confirmed to be alive, which is the most recent of their discontinuation date or latest follow-up date.
PFS is a survival analysis involving both the binary endpoint of whether or not each patient progressed or not (i.e. were censored), and the months-to-progression times for each patient.
|
For each subject, from enrollment until the end of their months-to-progression (as defined above)
|
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OS - Response-Evaluable Population
時間枠：For each subject, from enrollment until the end of their months-to-death time (as defined above)
|
Months-to-death is defined as the number of months from enrollment until death from any cause.
Subjects who did not die will be considered to be censored at the latest date they are confirmed to be alive, which is the most recent of their discontinuation date or latest follow-up date.
OS is a survival analysis involving both the binary endpoint of whether or not each patient died or not, and the months-to-death times for each patient.
|
For each subject, from enrollment until the end of their months-to-death time (as defined above)
|
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ORR - Response-Evaluable Population
時間枠：The duration of time during which tumor assessments were performed for each patient, until they experience disease progression. The latest timepoint an assessment was performed was at Cycle 21 Day 15 (14.5 mo after informed consent).
|
A patient is considered to be an objective responder if their best overall response (BOR) of their follow-up tumor assessments was assessed to be complete response (CR) or partial response (PR) per RECIST v1.1.
ORR is defined as the proportion of patients who were classified as objective responders.
|
The duration of time during which tumor assessments were performed for each patient, until they experience disease progression. The latest timepoint an assessment was performed was at Cycle 21 Day 15 (14.5 mo after informed consent).
|
|
DCR - Response-Evaluable Population
時間枠：The duration of time during which tumor assessments were performed for each individual patient. Per protocol, assessments will continue until disease progression. The latest assessment was performed at Cycle 21, Day 15 (14.5 mo after informed consent).
|
A patient is classified as 'Disease Controlled' if their best overall response (BOR) of their follow-up tumor assessments was assessed to be complete response (CR), partial response (PR), or stable disease (SD) per RECIST v1.1.
DCR is defined as the proportion of patients who were classified as 'Disease Controlled'.
|
The duration of time during which tumor assessments were performed for each individual patient. Per protocol, assessments will continue until disease progression. The latest assessment was performed at Cycle 21, Day 15 (14.5 mo after informed consent).
|
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。
協力者
捜査官
- 主任研究者：Wells Messersmith, MD、University of Colorado, Denver
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
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)
2022年7月28日
一次修了 (実際)
2024年10月30日
研究の完了 (実際)
2024年10月30日
試験登録日
最初に提出
2021年9月27日
QC基準を満たした最初の提出物
2021年12月9日
最初の投稿 (実際)
2021年12月22日
学習記録の更新
投稿された最後の更新 (実際)
2026年9月3日
QC基準を満たした最後の更新が送信されました
2026年8月12日
最終確認日
2026年8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
- 22-0110.cc
- AGICC-ALX148 21CRC01 (その他の識別子：AGICC)
- NCI-2022-02019 (その他の助成金/資金番号：CTRP)
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。