Not currently recruiting at University of California Health

A Study to Learn About the Study Medicine Called PF-08046876 in People With Advanced Solid Tumors

a study on Solid Tumor Bladder Cancer Transitional Cell Carcinoma Lung Cancer Non-Small Cell Lung Cancer Head and Neck Squamous Cell Carcinoma Head and Neck Cancer Esophageal Cancer Gastroesophageal Junction Cancer Squamous Cell Carcinoma Pancreatic Cancer Urinary Bladder Tumor Head and Neck Tumor Pancreatic Neoplasms

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCLA
Dates
study started
study ends around

Description

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. 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.

Official Title

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

Keywords

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, B6C, integrin beta 6, ADC, antibody drug conjugate, non-small cell lung cancer, NSCLC, HNSCC, SCCHN, EC, PDAC, lung adenocarcinoma, lung squamous cell carcinoma, integrin alpha-v beta-6 receptor, ITGB6, Urinary Bladder Neoplasms, Transitional Cell Carcinoma, Non-Small-Cell Lung Carcinoma, Squamous Cell Carcinoma of Head and Neck, Head and Neck Neoplasms, Esophageal Neoplasms, Adenocarcinoma Of Esophagus, Pancreatic Neoplasms, Adenocarcinoma of Lung, pembrolizumab, Cisplatin, Carboplatin

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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

You CAN'T join if...

  • 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

Locations

  • Ronald Reagan UCLA Medical Center not yet accepting patients
    Los Angeles California 90095 United States
  • UCLA Department of Medicine-Hematology/Oncology not yet accepting patients
    Los Angeles California 90095 United States
  • Santa Monica UCLA Medical Center & Orthopaedic Hospital not yet accepting patients
    Santa Monica California 90404 United States
  • UCLA Hematology/Oncology - Santa Monica not yet accepting patients
    Santa Monica California 90404 United States
  • City of Hope at Irvine Lennar accepting new patients
    Irvine California 92618 United States
  • City of Hope National Medical Center accepting new patients
    Duarte California 91010 United States

Details

Status
accepting new patients at some sites,
but this study is not currently recruiting here
Start Date
Completion Date
(estimated)
Sponsor
Pfizer
ID
NCT07090499
Phase
Phase 1 research study
Study Type
Interventional
Participants
Expecting 540 study participants
Last Updated