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正在招募I 期编号 NCT06131840

A Study of SGN-CEACAM5C in Adults With Advanced Solid Tumors

报名条件（概要）

  • 年龄：18 Years – 不限
  • 性别：不限
  • 健康志愿者：不接受

完整入排标准请以官方页面为准。

开展国家/地区

United States、Canada、China、France、Israel、Japan、Netherlands、Spain、Sweden、United Kingdom

药品与企业信息

PF-08046050药物

其他名称：SAR445953; SGN-CEACAM5C

Given into the vein (IV; intravenous)

bevacizumab药物

Given into the vein (IV; intravenous)

5-Fluorouracil (5-FU)药物

Given into the vein (IV; intravenous)

Oxaliplatin药物

Given into the vein (IV; intravenous)

Leucovorin (LV)药物

Given into the vein (IV; intravenous)

研发企业

Seagen, a wholly owned subsidiary of Pfizer企业

试验官方登记的主要申办方；研究机构申办时会显示相应机构名称。

生产企业

公开药品批准资料或正式说明书暂未提供明确的生产企业信息。

合作机构

  • Sanofi企业

研发企业与生产企业可能不是同一家。研究阶段药品可能尚未公布生产企业；生产企业仅取自美国上市原研药说明书所列企业（不含仿制药），不作推测；仅在其他国家上市的药品暂无法显示。

研究简介（原文）

This clinical trial is studying advanced solid tumors. Solid tumors are cancers that start in a part of your body like your lungs or liver instead of your blood. Once tumors have grown bigger in one place but haven't spread, they're called locally advanced. If your cancer has spread to other parts of your body, it's called metastatic. When a cancer has gotten so big it can't easily be removed or has spread to other parts of the body, it is called unresectable. These types of cancer are harder to treat. Participants in this study must have cancer that has come back or did not get better with treatment. Participants must have a solid tumor cancer that can't be treated with standard of care drugs. This clinical trial uses an experimental drug called PF-08046050. PF-08046050 is a type of antibody-drug conjugate or ADC. ADCs are designed to stick to cancer cells and kill them. They may also stick to some normal cells. This study will test the safety of PF-08046050 in participants with solid tumors that are hard to treat or have spread throughout the body. This study has 5 different study parts. Part A and Part B of the study will find out how much PF-08046050 should be given to participants. Part C will use the information from Parts A and B to see if PF-08046050 is safe and if it works to treat certain solid tumor cancers. Part D and E of the study, together with information from Parts A and B, will find out how much PF-08046050 should be given in combination with other anti-cancer agents. Part E will use the information from Parts A, B, and D to see if PF-08046050 is safe in combination with other anti-cancer agents and if it works to treat a certain solid tumor.

适应症

Colorectal NeoplasmsCarcinoma, Non-Small-Cell LungStomach NeoplasmsPancreatic Ductal AdenocarcinomaGastroesophageal Junction AdenocarcinomaSmall Cell Lung Carcinoma

主动联系研究团队

总联系人（申办方／研究总部）

问自己是否符合条件、如何预筛

我的病情档案

管理档案

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英文版（发给研究团队）

Dear Study Team,

I am a patient in China and I am interested in participating in your clinical trial:

Study Title: A Study of SGN-CEACAM5C in Adults With Advanced Solid Tumors
ClinicalTrials.gov Identifier: NCT06131840
Sponsor: Seagen, a wholly owned subsidiary of Pfizer
Investigational product: PF-08046050, bevacizumab, 5-Fluorouracil (5-FU), Oxaliplatin, Leucovorin (LV)

About me:
- Age: (please fill in)
- Sex: (please fill in)
- Confirmed diagnosis and stage: (please fill in)
- Biomarkers / genetic testing: not available
- Prior and current treatments: (please fill in)
- Performance status (ECOG): not assessed
- Current location: China
- Travel ability: (please fill in)

Could you please let me know:
1. Whether I might be eligible for this study;
2. Which site would be closest and most practical for me, and whether remote pre-screening is possible;
3. What documents (medical records, pathology or imaging reports, recent labs) I should prepare for pre-screening.

I can provide English translations of my medical records. Thank you very much for your time and help.

Kind regards,
(your name)
(your email / phone with country code)

中文对照（供您核对）

尊敬的研究团队：

我是一位来自中国的患者，希望咨询参加以下临床试验的可能：

研究名称：A Study of SGN-CEACAM5C in Adults With Advanced Solid Tumors
试验编号：NCT06131840
申办方：Seagen, a wholly owned subsidiary of Pfizer
研究药物：PF-08046050、bevacizumab、5-Fluorouracil (5-FU)、Oxaliplatin、Leucovorin (LV)

我的基本情况：
- 年龄：（请填写）
- 性别：（请填写）
- 确诊疾病与分期：（请填写）
- 基因／标志物检测：暂无
- 既往及当前治疗：（请填写）
- 体能状态（ECOG）：未评估
- 目前所在城市：中国
- 可前往范围：（请填写）

想请教三个问题：
1. 我是否可能符合本研究的入组标准？
2. 哪个中心对我最方便可行？能否远程预筛？
3. 预筛需要准备哪些资料（病历、病理、影像、近期化验）？

我可以提供英文翻译版病历。感谢您的时间与帮助。

顺祝安康
（您的姓名）
（您的邮箱／带国际区号的电话）
用邮件客户端发送给 ClinicalTrials.gov_Inquiries@pfizer.com

提示：请与主治医生一起发信——由医生署名的申请，回复率远高于患者单独发信。首封邮件不要附身份证号等敏感信息。研究团队通常在 3–10 个工作日内回复，两周无回音可礼貌追问一次。

下一步怎么做？

  1. 把本页信息带给您的主治医生，评估是否适合参加。
  2. 点击下方按钮打开官方注册页，查看研究中心联系方式。
  3. 直接联系研究团队咨询报名事宜（通常有中文同声翻译服务可协助沟通）。
在 ClinicalTrials.gov 查看官方页面