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

2 november 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Geschat)

280

Fase

  • Fase 1

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

  • Verenigde Staten
    • Michigan
      • Grand Rapids, Michigan, Verenigde Staten, 49546
        • Werving
        • START Midwest, LLC
    • Tennessee
      • Nashville, Tennessee, Verenigde Staten, 37203
        • Werving
        • Sarah Cannon Research Institute - Pharmacy
      • Nashville, Tennessee, Verenigde Staten, 37203
        • Werving
        • SCRI Oncology Partners
    • Texas
      • San Antonio, Texas, Verenigde Staten, 78229
        • Werving
        • START San Antonio, LLC

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Niet-gerandomiseerd
  • Interventioneel model: Sequentiële toewijzing
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Part 1 Dose Escalation

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

IV infusion
Experimenteel: Part 2 Dose Expansion

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

IV infusion
Experimenteel: Part 2 Dose Optimization

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

IV infusion

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Incidence of Adverse Events (AEs)
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Objective Response Rate (ORR)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Pfizer

Onderzoekers

  • Studie directeur: Pfizer CT.gov Call Center, Pfizer

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Nuttige links

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

29 oktober 2026

Primaire voltooiing (Geschat)

26 januari 2031

Studie voltooiing (Geschat)

26 januari 2032

Studieregistratiedata

Eerst ingediend

12 oktober 2026

Eerst ingediend dat voldeed aan de QC-criteria

22 oktober 2026

Eerst geplaatst (Werkelijk)

29 oktober 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

3 november 2026

Laatste update ingediend die voldeed aan QC-criteria

2 november 2026

Laatst geverifieerd

1 november 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • C6261001
  • CEACAM5 EC4V (Andere identificatie: Alias Study Number)
  • 2026-527660-32-00 (Register-ID: CTIS (EU))

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Beschrijving IPD-plan

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.

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Ja

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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