A Study to Evaluate the Safety and Activity of GDC-7035 With Anti-Cancer Therapies in Participants With KRAS G12D-Mutated Unresectable Advanced or Metastatic Colorectal Cancer or Pancreatic Ductal Adenocarcinoma
A Phase Ib, Multicenter, Randomized Study Evaluating the Safety and Activity of GDC-7035 With Anti-Cancer Therapies as First-Line Treatment in Patients With KRAS G12D-Mutated Unresectable Advanced or Metastatic Colorectal Cancer or Pancreatic Ductal Adenocarcinoma
The primary purpose of this study is to evaluate the safety of GDC-7035 as a single agent and in combination with other anti-cancer therapies in participants with KRAS G12D-mutated metastatic colorectal cancer (CRC) or pancreatic ductal adenocarcinoma (PDAC). The study consists of a safety run-in period followed by a randomized/expansion period.
調査の概要
状態
研究の種類
入学 (推定)
段階
- フェーズ 1
連絡先と場所
研究連絡先
- 名前：Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry
研究連絡先のバックアップ
- 名前：Reference Study ID Number: GO46205 https://forpatients.roche.com/ No attachments to email below.
- 電話番号：888-662-6728 (U.S. Only)
- メール：global-roche-genentech-trials@gene.com
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Confirmed presence of the Kirsten rat sarcoma viral oncogene homolog (KRAS) G12D mutation as documented through central laboratory testing or prior local laboratory testing
- Agreement to adhere to the contraception requirements described in the protocol for participants of childbearing potential and participants who produce sperm
Exclusion Criteria:
- Malabsorption syndrome or other conditions that would interfere with enteral absorption
- Known and untreated, or active central nervous system (CNS) metastases
- Known clinically significant liver disease
- History of or active clinically significant cardiovascular dysfunction
Other protocol-defined inclusion/exclusion criteria may apply.
研究計画
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：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 |
|---|---|
|
実験的：Group A: GDC-7035 + mFOLFOX6 + Panitumumab
Participants with CRC will receive GDC-7035 in combination with modified (levo)leucovorin, 5-fluorouracil (5-FU), oxaliplatin (mFOLFOX6) and panitumumab as per the schedule specified in the protocol during the safety run-in period. Participants in the randomized or expansion period will also receive GDC-7035 in combination with mFOLFOX6 and panitumumab at doses determined to be safe in the safety run-in period. |
Participants will receive GDC-7035 as per the schedule specified in the protocol.
他の名前：
Participants will receive panitumumab in accordance with the local prescribing information. Participants will receive mFOLFOX6 in accordance with the local prescribing information. |
|
実験的：Group B: GDC-7035 + FOLFIRI + Panitumumab
Participants with CRC will receive GDC-7035 in combination with leucovorin, 5-FU, irinotecan (FOLFIRI), and panitumumab as per the schedule specified in the protocol during the safety run-in period. Participants in the randomized or expansion period will also receive GDC-7035 in combination with FOLFIRI and panitumumab at doses determined to be safe in the safety run-in period. |
Participants will receive GDC-7035 as per the schedule specified in the protocol.
他の名前：
Participants will receive panitumumab in accordance with the local prescribing information. Participants will receive FOLFIRI in accordance with the local prescribing information. |
|
実験的：Group C: GDC-7035 + mFOLFIRINOX or GDC-7035 Monotherapy
Participants with PDAC will receive GDC-7035 in combination with modified leucovorin, 5-FU, irinotecan, oxaliplatin (mFOLFIRINOX) as per the schedule specified in the protocol during the safety run-in period. Participants in the randomized or expansion period will also receive GDC-7035 as a single agent or in combination with mFOLFIRINOX at doses determined to be safe in the safety run-in period. |
Participants will receive GDC-7035 as per the schedule specified in the protocol.
他の名前：
Participants will receive mFOLFIRINOX in accordance with the local prescribing information. |
|
実験的：Group D: GDC-7035 + Gem-nabP or GDC-7035 Monotherapy
Participants with PDAC will receive GDC-7035 in combination with gemcitabine and nab-paclitaxel (Gem-nabP) as per the schedule specified in the protocol during the safety run-in period. Participants in the randomized or expansion period will also receive GDC-7035 as a single agent or in combination with Gem-nabP at doses determined to be safe in the safety run-in period. |
Participants will receive GDC-7035 as per the schedule specified in the protocol.
他の名前：
Participants will receive Gem-nabP in accordance with the local prescribing information. |
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 |
|---|---|
|
Number of Participants With Adverse Events (AEs)
時間枠：Up to approximately 30 months
|
Up to approximately 30 months
|
|
Number of Participants With Key Treatment-Emergent Adverse Events (TEAEs)
時間枠：Up to Day 28
|
Up to Day 28
|
二次結果の測定
結果測定 |
時間枠 |
|---|---|
|
応答期間 (DOR)
時間枠：最長約30ヶ月
|
最長約30ヶ月
|
|
客観的な回答率（ORR）
時間枠：約30か月まで
|
約30か月まで
|
|
Progression-free Survival (PFS) After Randomization
時間枠：Up to approximately 30 months
|
Up to approximately 30 months
|
協力者と研究者
スポンサー
捜査官
- スタディディレクター：Clinical Trials、Hoffmann-La Roche
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- GO46205
- 2026-525460-17-00 (Ctis)
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?
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
米国FDA規制機器製品の研究
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。