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.
研究概览
地位
研究类型
注册 (估计的)
阶段
- 阶段1
联系人和位置
学习联系方式
- 姓名：Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry
研究联系人备份
- 姓名：Reference Study ID Number: GO46205 https://forpatients.roche.com/ No attachments to email below.
- 电话号码：888-662-6728 (U.S. Only)
- 邮箱：global-roche-genentech-trials@gene.com
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
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.
学习计划
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：顺序分配
- 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：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.
其他名称：
Participants will receive panitumumab in accordance with the local prescribing information. Participants will receive mFOLFOX6 in accordance with the local prescribing information. |
|
实验性的：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.
其他名称：
Participants will receive panitumumab in accordance with the local prescribing information. Participants will receive FOLFIRI in accordance with the local prescribing information. |
|
实验性的：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.
其他名称：
Participants will receive mFOLFIRINOX in accordance with the local prescribing information. |
|
实验性的：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.
其他名称：
Participants will receive Gem-nabP in accordance with the local prescribing information. |
研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
Number of Participants With Adverse Events (AEs)
大体时间：Up to approximately 30 months
|
Up to approximately 30 months
|
|
Number of Participants With Key Treatment-Emergent Adverse Events (TEAEs)
大体时间：Up to Day 28
|
Up to Day 28
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
|
缓解持续时间 (DOR)
大体时间：最长约 30 个月
|
最长约 30 个月
|
|
客观响应率（ORR）
大体时间：大约30个月
|
大约30个月
|
|
Progression-free Survival (PFS) After Randomization
大体时间：Up to approximately 30 months
|
Up to approximately 30 months
|
合作者和调查者
调查人员
- 研究主任：Clinical Trials、Hoffmann-La Roche
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- GO46205
- 2026-525460-17-00 (克蒂斯)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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