A Phase 1 Open-label Study to Investigate PF-08046876 in Adult Participants With Advanced Solid Tumors.

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
Texas
NEXT Oncology
RECRUITING
San Antonio
Other Locations
Puerto Rico
Pan American Center for Oncology Trials, LLC
RECRUITING
Rio Piedras
Contact Information
Primary
Pfizer CT.gov Call Center
ClinicalTrials.gov_Inquiries@pfizer.com
1-800-718-1021
Time Frame
Start Date: 2025-08-20
Estimated Completion Date: 2029-07-08
Participants
Target number of participants: 310
Treatments
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
Sponsors
Leads: Pfizer

This content was sourced from clinicaltrials.gov

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