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
| Arm | Description | Assigned Intervention |
|---|---|---|
|
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 |
|
Recruiting Locations
City of Hope National Medical Center
Duarte, California 91010
Duarte, California 91010
City of Hope at Irvine Lennar
Irvine, California 92618
Irvine, California 92618
Smilow Cancer Hospital - Yale New Haven Health
New Haven, Connecticut 06510
New Haven, Connecticut 06510
Yale - New Haven Hospital - Yale Cancer Center
New Haven, Connecticut 06510
New Haven, Connecticut 06510
Smilow Cancer Hospital Phase 1 Unit
New Haven, Connecticut 06511
New Haven, Connecticut 06511
Smilow Cancer Hospital - Trumbull
Trumbull, Connecticut 06611
Trumbull, Connecticut 06611
Brigham and Women's Hospital
Boston, Massachusetts 02115
Boston, Massachusetts 02115
Dana-Farber Cancer Institute
Boston, Massachusetts 02215
Boston, Massachusetts 02215
Dana-Farber Cancer Institute - Chestnut Hill
Newton, Massachusetts 02467
Newton, Massachusetts 02467
Sarah Cannon Research Institute - Pharmacy
Nashville, Tennessee 37203
Nashville, Tennessee 37203
SCRI Oncology Partners
Nashville, Tennessee 37203
Nashville, Tennessee 37203
NEXT Oncology
San Antonio, Texas 78229
San Antonio, Texas 78229
Pan American Center for Oncology Trials, LLC
Rio Piedras, Puerto Rico 00935
Rio Piedras, Puerto Rico 00935
More Details
- Status
- Recruiting
- Sponsor
- Pfizer