A Phase 1 interventional study of PF-08098488 in Pancreatic Ductal Adenocarcinoma, Esophageal Cancer and Carcinoma, Non-Small-Cell Lung (NSCLC), sponsored by Pfizer. Recruiting at 4 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-03.
Sponsored by Pfizer · Phase 1, Interventional, and Treatment
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:
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.
1,635 studies on the registry are indexed under Esophageal Neoplasms; 469 are open to participants now.
This study's planned enrollment of 280 is above the median of 60 across 1,201 interventional studies indexed under Esophageal Neoplasms.
Browse Esophageal Neoplasms studies →Pfizer is the lead sponsor of 3,331 studies on the registry; 148 are open to participants now.
Of its 600 completed or terminated interventional studies of FDA-regulated products, 391 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Different groups of participants will receive different doses and/or schedules of the study drug
Drug: PF-08098488
Participants in tumor-specific groups will receive 1 dosing regimen deemed to be safe in Part 1
Drug: PF-08098488
Participants will be assigned to one of two dosing regimens deemed to be safe in Part 1
Drug: PF-08098488
IV infusion
Incidence of Adverse Events (AEs)
Number of participants with AEs, characterized by type, frequency, severity, seriousness, and relationship to study intervention during the AE evaluation period.
Time frame: 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)
Time frame: From first dose through completion of Part 1, an average of 1 year
Part 2: Recommended Monotherapy Dose for Further Development
Time frame: From first dose through completion of Part 2, an average of 2 years
Objective Response Rate (ORR)
Percentage of participants with a confirmed complete response (CR) or partial response (PR) according to RECIST v1.1 as assessed by the investigator.
Time frame: 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)
Time in weeks/months from the first documentation of objective tumor response to objective tumor progression or death due to any cancer.
Time frame: 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)
PFS as defined per RECIST 1.1.
Time frame: From first dose until disease progression or death due to any cause, whichever occurs first, up to approximately 3 years
Overall Survival (OS)
Time in weeks from the start of study treatment to date of death due to any cause.
Time frame: From first dose until death due to any cause, up to approximately 3 years
Maximum Observed Serum Concentration (Cmax)
Time frame: From first dose through End of Treatment (EOT), up to approximately 3 years
Area under the concentration-time curve (AUC)
Time frame: From first dose through End of Treatment (EOT), up to approximately 3 years
Time to Maximum Observed Serum Concentration (Tmax)
Time frame: From first dose through End of Treatment (EOT), up to approximately 3 years
Number of Participants With Anti-drug Antibody (ADA) against PF-08098488
Time frame: Start of study treatment to 30 days after last dose of study drug administration
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Plan to share: No — 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.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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