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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.

調査の概要

状態

募集

条件

介入・治療

研究の種類

介入

入学 (推定)

280

段階

  • フェーズ 1

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。

研究連絡先

研究場所

  • アメリカ
    • Michigan
      • Grand Rapids、Michigan、アメリカ、49546
        • 募集
        • START Midwest, LLC
    • Tennessee
      • Nashville、Tennessee、アメリカ、37203
        • 募集
        • Sarah Cannon Research Institute - Pharmacy
      • Nashville、Tennessee、アメリカ、37203
        • 募集
        • SCRI Oncology Partners
    • Texas
      • San Antonio、Texas、アメリカ、78229
        • 募集
        • START San Antonio, LLC

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

受講資格のある性別

全て

説明

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.

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
実験的：Part 1 Dose Escalation

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

IV infusion
実験的：Part 2 Dose Expansion

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

IV infusion
実験的：Part 2 Dose Optimization

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

IV infusion

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
Incidence of Adverse Events (AEs)
時間枠：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)
時間枠：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
時間枠：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

二次結果の測定

結果測定
メジャーの説明
時間枠
Objective Response Rate (ORR)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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
時間枠：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

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。

スポンサー

Pfizer

捜査官

  • スタディディレクター：Pfizer CT.gov Call Center、Pfizer

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。

便利なリンク

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 (推定)

2026年10月29日

一次修了 (推定)

2031年1月26日

研究の完了 (推定)

2032年1月26日

試験登録日

最初に提出

2026年10月12日

QC基準を満たした最初の提出物

2026年10月22日

最初の投稿 (実際)

2026年10月29日

学習記録の更新

投稿された最後の更新 (実際)

2026年11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11月2日

最終確認日

2026年11月1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

  • C6261001
  • CEACAM5 EC4V (その他の識別子：Alias Study Number)
  • 2026-527660-32-00 (レジストリ識別子：CTIS (EU))

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?

いいえ

IPD プランの説明

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.

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。

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