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

Pfizer

Status and phase: Enrolling; Phase 1

Conditions: Esophageal Cancer; Gastric Carcinoma; Carcinoma, Non-Small-Cell Lung (NSCLC); Pancreatic Ductal Adenocarcinoma; Gastroesophageal Junction Adenocarcinoma

Treatments: Drug: PF-08098488

Study type: Interventional

Funder types: Industry

Identifiers

NCT07903415

C6261001

2026-527660-32-00 (Registry Identifier)

CEACAM5 EC4V (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 280 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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280 participants in 3 patient groups

Part 1 Dose Escalation

Experimental group

Description:

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

Treatment:

Drug: PF-08098488

Part 2 Dose Expansion

Experimental group

Description:

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

Treatment:

Drug: PF-08098488

Part 2 Dose Optimization

Experimental group

Description:

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

Treatment:

Drug: PF-08098488