Phase 1Recruiting
A Study to Learn About the Study Medicine Called PF-08046876 in People With Advanced Solid Tumors
A Phase 1 Open-label Study to Investigate PF-08046876 in Adult Participants With Advanced Solid Tumors.
- Sponsor
- Pfizer (Industry)
- Enrolment
- 540 planned
- 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
- Interventions
- PF-08046876; Pembrolizumab; Cisplatin; Carboplatin
- Ages
- adults, older adults
- Registry
- NCT07090499
From the registry
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. In the second part of the study, groups of people will receive the study drug in dosing regimens deemed to be safe in Part 1. In the third part of the study, people will receive the study drug together with other anti-cancer medicines.
Primary outcomes
- Incidence of Treatment Emergent Adverse Events (TEAEs) estimated during the Adverse Events (AE) evaluation
- Part 1: Number of Participants With Dose-limiting Toxicities (DLTs): Monotherapy
- Part 1: Recommended Monotherapy Dose for Expansion
- Part 2: Recommended Monotherapy Phase 2 Dose