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

2 november 2026 uppdaterad av: 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.

Studieöversikt

Status

Rekrytering

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Beräknad)

280

Fas

  • Fas 1

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Icke-randomiserad
  • Interventionsmodell: Sekventiell tilldelning
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Part 1 Dose Escalation

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

IV infusion
Experimentell: Part 2 Dose Expansion

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

IV infusion
Experimentell: Part 2 Dose Optimization

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

IV infusion

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Incidence of Adverse Events (AEs)
Tidsram: 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)
Tidsram: 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
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Objective Response Rate (ORR)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Pfizer

Utredare

  • Studierektor: Pfizer CT.gov Call Center, Pfizer

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Användbara länkar

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Beräknad)

29 oktober 2026

Primärt slutförande (Beräknad)

26 januari 2031

Avslutad studie (Beräknad)

26 januari 2032

Studieregistreringsdatum

Först inskickad

12 oktober 2026

Först inskickad som uppfyllde QC-kriterierna

22 oktober 2026

Första postat (Faktisk)

29 oktober 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

3 november 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

2 november 2026

Senast verifierad

1 november 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • C6261001
  • CEACAM5 EC4V (Annan identifierare: Alias Study Number)
  • 2026-527660-32-00 (Registeridentifierare: CTIS (EU))

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

IPD-planbeskrivning

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.

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Ja

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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