ACTIVE_NOT_RECRUITING

A Clinical Trial of PF-08046037 Alone or With Sasanlimab in Patients With Advanced or Metastatic Malignancies

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of this study is to learn about the safety and the effects of PF-08046037 alone or with sasanlimab for the treatment of certain advanced or metastatic malignancies. This study is seeking participants who: * have advanced or metastatic non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), melanoma, or pancreatic ductal adenocarcinoma (PDAC); * are able to provide tumor tissue samples; * have measurable disease. All participants will receive while at the clinic PF-08046037 alone as an intravenous (IV) infusion (given directly into a vein) or with sasanlimab as a subcutaneous (SQ) injection (given under the skin) once every 3 weeks. Participants will continue to take the study drug(s) until their cancer is no longer responding or if the patient cannot safely take them. The study team will monitor how each participant is doing with the study treatment during regular visits at the study clinic.

Official Title

AN OPEN-LABEL PHASE 1 STUDY TO EVALUATE PF-08046037 AS MONOTHERAPY AND PART OF COMBINATION THERAPY IN PARTICIPANTS WITH ADVANCED MALIGNANCIES

Quick Facts

Study Start:2025-05-06
Study Completion:2026-04-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06974734

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Principal Investigator

Pfizer CT.gov Call Center
STUDY_DIRECTOR
Pfizer

Study Locations (Sites)

Presbyterian/ St. Lukes Medical Center
Denver, Colorado, 80218
United States
Sarah Cannon Research Institute at HealthONE
Denver, Colorado, 80218
United States
Smilow Cancer Hospital - Yale New Haven Health
New Haven, Connecticut, 06510
United States
Yale - New Haven Hospital - Yale Cancer Center
New Haven, Connecticut, 06510
United States
Smilow Cancer Hospital Phase 1 Unit
New Haven, Connecticut, 06511
United States
Smilow Cancer Hospital - Trumbull
Trumbull, Connecticut, 06611
United States
Community Health Network, Inc
Indianapolis, Indiana, 46219
United States
Community Health Network, Inc.
Indianapolis, Indiana, 46227
United States
Community Health Network, Inc.
Indianapolis, Indiana, 46250
United States
Community Health Network, Inc.
Indianapolis, Indiana, 46256
United States
START Midwest
Grand Rapids, Michigan, 49546
United States
UPMC Vision Center
Pittsburgh, Pennsylvania, 15219
United States
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232
United States
UPMC Presbyterian Shadyside Hospital
Pittsburgh, Pennsylvania, 15232
United States
Sarah Cannon Research Institute - Pharmacy
Nashville, Tennessee, 37203
United States
SCRI Oncology Partners
Nashville, Tennessee, 37203
United States
Tristar Centennial Medical Center
Nashville, Tennessee, 37203
United States
Methodist Hospital
San Antonio, Texas, 78229
United States
START San Antonio
San Antonio, Texas, 78229
United States

Collaborators and Investigators

Sponsor: Pfizer

  • Pfizer CT.gov Call Center, STUDY_DIRECTOR, Pfizer

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-05-06
Study Completion Date2026-04-30

Study Record Updates

Study Start Date2025-05-06
Study Completion Date2026-04-30

Terms related to this study

Keywords Provided by Researchers

  • Advanced solid tumors
  • NSCLC
  • PDAC
  • HNSCC
  • ISAC
  • ADC
  • PD-L1 inhibitor

Additional Relevant MeSH Terms

  • Carcinoma, Non Small Cell Lung
  • Carcinoma, Pancreatic Ductal
  • Malignant Melanoma
  • Squamous Cell Carcinoma of the Head and Neck (SCCHN)