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Pancreatic Ductal AdenocarcinomaPhase 1NCT07903415

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

A Phase 1 study testing PF-08098488 in people with Pancreatic Ductal Adenocarcinoma and Esophageal Cancer, run by Pfizer at 2 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
PF-08098488
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
280 participants
Where
2 sitesUnited States
Study dates
29 Oct 2026to 26 Jan 2032
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 9Show fewer
  • 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

Who cannot join

  • 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.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Pfizer CT.gov Call Center contact

1-800-718-1021

ClinicalTrials.gov_Inquiries@pfizer.com

United States2 sites, 2 recruiting

  • START Midwest, LLC

    Grand Rapids, Michigan, 49546

    Recruiting

  • START San Antonio, LLC

    San Antonio, Texas, 78229

    Recruiting

Other trials in United States

About this study

Official title: 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:

Read more
  • 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.

Being tested
PF-08098488
Keywords
NSCLC, Pancreatic Cancer, Stomach Cancer, Gastric Cancer, Esophageal Cancer, metastatic cancer, advanced cancer, solid tumors, Lung Cancer
Medical subject headings
Esophageal Neoplasms, Carcinoma, Carcinoma, Non-Small-Cell Lung, Stomach Neoplasms, Pancreatic Neoplasms, Neoplasm Metastasis, Lung Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PF-08098488Drug

    IV infusion

Study groups in NCT07903415
Study groupRoleWhat they receive
Part 1 Dose EscalationExperimentalDifferent groups of participants will receive different doses and/or schedules of the study drug
Receives: Drug: PF-08098488
Part 2 Dose ExpansionExperimentalParticipants in tumor-specific groups will receive 1 dosing regimen deemed to be safe in Part 1
Receives: Drug: PF-08098488
Part 2 Dose OptimizationExperimentalParticipants will be assigned to one of two dosing regimens deemed to be safe in Part 1
Receives: Drug: PF-08098488

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Start of study treatment to 30 days after the last dose of study drug administration or start of new anticancer therapy (whichever occurs first)

  2. Part 1: Recommended Monotherapy Dose(s) for Expansion (RDEM)

    Measured: From first dose through completion of Part 1, an average of 1 year

  3. Part 2: Recommended Monotherapy Dose for Further Development

    Measured: From first dose through completion of Part 2, an average of 2 years

Secondary outcomes (8)

  1. 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.

    Measured: From baseline until first documented disease progression, death, or start of new anticancer therapy, whichever occurs first, up to approximately 3 years

  2. 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.

    Measured: From the date of first objective response until disease progression or death due to any cause, whichever occurs first, up to approximately 3 years

  3. Progression Free Survival (PFS)

    PFS as defined per RECIST 1.1.

    Measured: From first dose until disease progression or death due to any cause, whichever occurs first, up to approximately 3 years

  4. Overall Survival (OS)

    Time in weeks from the start of study treatment to date of death due to any cause.

    Measured: From first dose until death due to any cause, up to approximately 3 years

  5. Maximum Observed Serum Concentration (Cmax)

    Measured: From first dose through End of Treatment (EOT), up to approximately 3 years

  6. Area under the concentration-time curve (AUC)

    Measured: From first dose through End of Treatment (EOT), up to approximately 3 years

  7. Time to Maximum Observed Serum Concentration (Tmax)

    Measured: From first dose through End of Treatment (EOT), up to approximately 3 years

  8. Number of Participants With Anti-drug Antibody (ADA) against PF-08098488

    Measured: Start of study treatment to 30 days after last dose of study drug administration

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Oct 2026
  2. Study start29 Oct 2026 (estimated)
  3. Primary completion26 Jan 2031 (estimated)
  4. Study completion26 Jan 2032 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
280 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07903415
Sponsor's protocol ID
C6261001
Other IDs
CEACAM5 EC4V, 2026-527660-32-00
Status last verified
Oct 2026
First submitted
12 Oct 2026
Last updated
29 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
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.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing PF-08098488 in people with Pancreatic Ductal Adenocarcinoma and Esophageal Cancer, run by Pfizer at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Pfizer CT.gov Call Center (1-800-718-1021, ClinicalTrials.gov_Inquiries@pfizer.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Adverse Events (AEs) (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)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07903415.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.

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