Recruiting
Phase 1

PF-08098488

Sponsor:

Pfizer

Code:

NCT07903415

Conditions

Pancreatic Ductal Adenocarcinoma

Esophageal Cancer

Carcinoma, Non-Small-Cell Lung (NSCLC)

Gastric Carcinoma

Gastroesophageal Junction Adenocarcinoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

PF-08098488

Study Details

Brief 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). 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.

Conditions

Pancreatic Ductal Adenocarcinoma

Esophageal Cancer

Carcinoma, Non-Small-Cell Lung (NSCLC)

Gastric Carcinoma

Gastroesophageal Junction Adenocarcinoma

Study ID

NCT07903415

Start date

Oct 29, 2026

Status verified date

Oct, 2026

Completion date

Jan 26, 2032

Anticipated

Primary completion date

Jan 26, 2031

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

280 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Part 1 Dose Escalation

Different groups of participants will receive different doses and/or schedules of the study drug

experimental: Part 2 Dose Expansion

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

experimental: Part 2 Dose Optimization

Participants will be assigned to one of two dosing regimens deemed to be safe in Part 1

Interventions

PF-08098488

IV infusion

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) ]
  • 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 ]

Central Contacts and Locations

Central contacts

Pfizer CT.gov Call Center

1-800-718-1021ClinicalTrials.gov_Inquiries@pfizer.com

Locations

START Midwest, LLC

Recruiting

Grand Rapids, Michigan, United States, 49546

START San Antonio, LLC

Recruiting

San Antonio, Texas, United States, 78229

More Information

Sponsor

Pfizer

Last update posted

Oct 29, 2026

Last verified

Oct, 2026

Keywords

  • NSCLC
  • Pancreatic Cancer
  • Stomach Cancer
  • Gastric Cancer
  • Esophageal Cancer
  • metastatic cancer
  • advanced cancer
  • solid tumors
  • Lung Cancer

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-30. This information was provided to ClinicalTrials.gov by Pfizer on 2026-10-29. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.