A Study to Learn About the Study Medicine Called PF-08046876 in People With Advanced Solid Tumors

Pfizer

Status and phase: Enrolling; Phase 1

Conditions: Esophageal Cancer; Pancreatic Adenocarcinoma; Urothelial Carcinoma; Advanced/Metastatic Solid Tumors; Advanced Non-Small Cell Lung Cancer; Carcinoma, Non Small Cell Lung; Bladder Cancer; Esophageal Squamous Cell Carcinoma; Esophageal Adenocarcinoma; Head and Neck Cancer; Gastroesophageal Junction Adenocarcinoma; Carcinoma, Squamous Cell of Head and Neck; Pancreatic Cancer

Treatments: Drug: PF-08046876

Study type: Interventional

Funder types: Industry

Identifiers

NCT07090499

C5951001

2025-521729-33-00 (Registry Identifier)

Details and patient eligibility

About

The purpose of the study is to explore the safety and effects of the study drug (PF-08046876) in people diagnosed with advanced cancer of the bladder, lung, head and neck, esophagus, or pancreas. PF-08046876 is an investigational anticancer therapy called an 'antibody drug conjugate' or 'ADC'. ADCs are anticancer drugs designed to stick to cancer cells and kill them.

The study drug will be given to participants through a needle in a vein (intravenous infusion). This study includes multiple parts. In the first part of the study, there will be different groups of people receiving different doses of the study drug. The study may also test different schedules.

Enrollment: 310 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 18 years of age or older
• Advanced cancer of the bladder, lung, head and neck, esophagus, or pancreas
• Measurable disease
• ECOG Performance status 0-1
• Part 1: progression or relapse following standard treatments
• 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 a camptothecin-class payload (e.g. sacituzumab govitecan, trastuzumab deruxtecan )
• Active anorexia, nausea or vomiting, and/or signs of intestinal obstruction meeting protocol exclusion
• Pulmonary disease meeting protocol exclusion
• Other unacceptable abnormalities as defined by protocol

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Sequential Assignment

Masking: None (Open label)

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310 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-08046876

Part 2 Dose Optimization

Experimental group

Description:

Participants will be randomized to 2 dosing regimens deemed to be safe in Part 1

Treatment:

Drug: PF-08046876

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-08046876