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

Conditions

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

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• PF-08046876 — DRUG
  Intravenous administration

Study Details

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.

Key Dates

Start date

Aug 20, 2025

Status verified

Apr 2026

Primary completion

Jul 8, 2028

Completion

Jul 8, 2029

Study Design

Enrollment

310 participants (estimated)

Allocation

NA

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

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 Optimization
  Participants will be randomized to 2 dosing regimens deemed to be safe in Part 1
• Experimental: Part 2 Dose Expansion
  Participants in tumor-specific groups will receive 1 dosing regimen deemed to be safe in Part 1

Primary Outcome Measure

Incidence of Treatment Emergent Adverse Events (TEAEs) estimated during the Adverse Events (AE) evaluation [ Time Frame: Start of treatment up to 30 days after last dose or start of new anticancer therapy (whichever occurs first) ]

Central Contacts

• Pfizer CT.gov Call Center
  1-800-718-1021
  [email protected]

Locations (21)

Find similar trials in Duarte, CA

Related Studies

• Identification and Characterization of Novel Proteins and Genes in Head and Neck Cancer
  Recruiting · Stanford University · Stanford, California
• Identification of Secreted Markers for Tumor Hypoxia in Patients With Head and Neck or Lung Cancers
  Recruiting · Stanford University · Stanford, California
• Tissue Sample Collection From Patients With Head and Neck Cancer and From Healthy Participants
  Recruiting · Vanderbilt University Medical Center · Nashville, Tennessee
• Gastrointestinal Biomarkers in Tissue and Biological Fluid Samples From Colorectal Cancer Patients
  Recruiting · Vanderbilt University Medical Center · Nashville, Tennessee