Dysautonomia International

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	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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.