此页面是自动翻译的，不保证翻译的准确性。请参阅 英文版 对于源文本。

A Study to Learn About the Study Medicine Called PF-08098488 in People With Advanced Solid Tumors.

2026年11月2日 更新者：Pfizer

A PHASE 1, OPEN-LABEL STUDY TO INVESTIGATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND ANTITUMOR ACTIVITY OF PF-08098488 IN ADULT PARTICIPANTS WITH ADVANCED SOLID TUMORS.

The purpose of this clinical study is to learn about the safety and effects of the study medicine (called PF-08098488) in people with advanced solid tumors (cancer that cannot be removed with surgery or has spread to other parts of the body). PF-08098488 is being studied as a possible treatment for certain types of cancer. These include non-small cell lung cancer, pancreatic cancer, stomach or gastroesophageal junction cancer, and esophageal cancer. This study will also help researchers learn how the study medicine moves through and affects the body.

This study is seeking adults who:

  • Have advanced non-small cell lung cancer, pancreatic cancer, stomach or gastroesophageal junction cancer, or esophageal cancer.
  • Have received at least 1 previous treatment for their cancer.
  • Have cancer that has grown, returned, or is no longer responding to available treatments.

All participants in this study will receive PF-08098488 as an IV infusion (given directly into a vein) at the study clinic. Researchers will study different dose levels and dosing schedules to find the dose that is safe and may work best. Participants will be monitored closely during treatment, especially after their first infusion. They may continue receiving the study medicine as long as their cancer is not getting worse and they are tolerating treatment.

The study includes a screening period of up to 28 days. Participants will have regular visits to the study clinic for treatment and health assessments. These assessments include scans to monitor the cancer and blood sample collection. Tumor tissue samples will also be collected when available or medically feasible. After treatment ends, participants will have a follow-up visit about 1 month later. They will then be contacted about every 12 weeks to check on their health.

研究概览

地位

招聘中

条件

干预/治疗

研究类型

介入性

注册 (估计的)

280

阶段

  • 阶段1

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

学习地点

  • 美国
    • Michigan
      • Grand Rapids、Michigan、美国、49546
        • 招聘中
        • START Midwest, LLC
    • Tennessee
      • Nashville、Tennessee、美国、37203
        • 招聘中
        • Sarah Cannon Research Institute - Pharmacy
      • Nashville、Tennessee、美国、37203
        • 招聘中
        • SCRI Oncology Partners
    • Texas
      • San Antonio、Texas、美国、78229
        • 招聘中
        • START San Antonio, LLC

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • 18 years of age or older
  • Advanced non-small cell lung cancer, pancreatic ductal adenocarcinoma, gastric cancer (including gastroesophageal junction carcinoma), or esophageal cancer.
  • Eastern Cooperative Oncology Group (ECOG) Performance status 0-1
  • Measurable disease
  • Must have received at least 1 prior approved systemic therapy:
  • Part 1: progression or relapse following standard treatments and have no other appropriate standard of care option.
  • Part 2: maximum of 2 prior lines of systemic therapy in the advanced setting.
  • Resolution of acute effects of prior anticancer therapy to baseline or Grade 1
  • Consent to submit required pre-treatment tumor tissue as medically feasible

Exclusion Criteria:

  • Received prior treatment with an antibody drug conjugate with an auristatin or microtubule inhibitor payload.
  • Unacceptable renal, hepatic, hematologic, cardiologic, pulmonary, or abnormalities as defined by the protocol.
  • Pre-existing sensory or motor neuropathy.
  • Uncontrolled diabetes mellitus.
  • Clinically significant and/ or symptomatic eye disease meeting protocol exclusion criteria.
  • Pulmonary (lung) disease meeting protocol exclusion criteria.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：非随机化
  • 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：Part 1 Dose Escalation

Different groups of participants will receive different doses and/or schedules of the study drug
药品：PF-08098488

IV infusion
实验性的：Part 2 Dose Expansion

Participants in tumor-specific groups will receive 1 dosing regimen deemed to be safe in Part 1
药品：PF-08098488

IV infusion
实验性的：Part 2 Dose Optimization

Participants will be assigned to one of two dosing regimens deemed to be safe in Part 1
药品：PF-08098488

IV infusion

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Incidence of Adverse Events (AEs)
大体时间：Start of study treatment to 30 days after the last dose of study drug administration or start of new anticancer therapy (whichever occurs first)

Number of participants with AEs, characterized by type, frequency, severity, seriousness, and relationship to study intervention during the AE evaluation period.
Start of study treatment to 30 days after the last dose of study drug administration or start of new anticancer therapy (whichever occurs first)
Part 1: Recommended Monotherapy Dose(s) for Expansion (RDEM)
大体时间：From first dose through completion of Part 1, an average of 1 year
From first dose through completion of Part 1, an average of 1 year
Part 2: Recommended Monotherapy Dose for Further Development
大体时间：From first dose through completion of Part 2, an average of 2 years
From first dose through completion of Part 2, an average of 2 years

次要结果测量

结果测量
措施说明
大体时间
Objective Response Rate (ORR)
大体时间：From baseline until first documented disease progression, death, or start of new anticancer therapy, whichever occurs first, up to approximately 3 years

Percentage of participants with a confirmed complete response (CR) or partial response (PR) according to RECIST v1.1 as assessed by the investigator.
From baseline until first documented disease progression, death, or start of new anticancer therapy, whichever occurs first, up to approximately 3 years
Duration of Response (DOR)
大体时间：From the date of first objective response until disease progression or death due to any cause, whichever occurs first, up to approximately 3 years

Time in weeks/months from the first documentation of objective tumor response to objective tumor progression or death due to any cancer.
From the date of first objective response until disease progression or death due to any cause, whichever occurs first, up to approximately 3 years
Progression Free Survival (PFS)
大体时间：From first dose until disease progression or death due to any cause, whichever occurs first, up to approximately 3 years

PFS as defined per RECIST 1.1.
From first dose until disease progression or death due to any cause, whichever occurs first, up to approximately 3 years
Overall Survival (OS)
大体时间：From first dose until death due to any cause, up to approximately 3 years

Time in weeks from the start of study treatment to date of death due to any cause.
From first dose until death due to any cause, up to approximately 3 years
Maximum Observed Serum Concentration (Cmax)
大体时间：From first dose through End of Treatment (EOT), up to approximately 3 years
From first dose through End of Treatment (EOT), up to approximately 3 years
Area under the concentration-time curve (AUC)
大体时间：From first dose through End of Treatment (EOT), up to approximately 3 years
From first dose through End of Treatment (EOT), up to approximately 3 years
Time to Maximum Observed Serum Concentration (Tmax)
大体时间：From first dose through End of Treatment (EOT), up to approximately 3 years
From first dose through End of Treatment (EOT), up to approximately 3 years
Number of Participants With Anti-drug Antibody (ADA) against PF-08098488
大体时间：Start of study treatment to 30 days after last dose of study drug administration
Start of study treatment to 30 days after last dose of study drug administration

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Pfizer

调查人员

  • 研究主任：Pfizer CT.gov Call Center、Pfizer

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

有用的网址

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年10月29日

初级完成 (估计的)

2031年1月26日

研究完成 (估计的)

2032年1月26日

研究注册日期

首次提交

2026年10月12日

首先提交符合 QC 标准的

2026年10月22日

首次发布 (实际的)

2026年10月29日

研究记录更新

最后更新发布 (实际的)

2026年11月3日

上次提交的符合 QC 标准的更新

2026年11月2日

最后验证

2026年11月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • C6261001
  • CEACAM5 EC4V (其他标识符：Alias Study Number)
  • 2026-527660-32-00 (注册表标识符：CTIS (EU))

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

IPD 计划说明

Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

是的

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

订阅