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

Purpose

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.

Conditions

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

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
N/A
Intervention Model
Sequential Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Part 1 Dose Escalation 		Different groups of participants will receive different doses and/or schedules of the study drug
  • Drug: PF-08046876
    Intravenous administration
Experimental
Part 2 Dose Optimization 		Participants will be randomized to 2 dosing regimens deemed to be safe in Part 1
  • Drug: PF-08046876
    Intravenous administration
Experimental
Part 2 Dose Expansion 		Participants in tumor-specific groups will receive 1 dosing regimen deemed to be safe in Part 1
  • Drug: PF-08046876
    Intravenous administration

Recruiting Locations

NEXT Oncology
San Antonio 4726206, Texas 4736286 78229

Pan American Center for Oncology Trials, LLC
Rio Piedras 4829037, Puerto Rico 00935

More Details

Status
Recruiting
Sponsor
Pfizer

Study Contact

Pfizer CT.gov Call Center
1-800-718-1021
ClinicalTrials.gov_Inquiries@pfizer.com