A Study to Learn About the Study Medicine Called PF-08046876 in People With Advanced Solid Tumors
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. 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.
Eligibility
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
- Part 3: advanced cancer of the lung or bladder, prior treatment requirements vary by combination therapy group
- 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
- Part 3: Meet contraindications of combination products per protocol and/or local labels
Join this Trial
- Rachel Andes
- UCLA Santa Monica