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Brief Title: Study to Test the Safety and Tolerability of PF-07209960 in Advanced or Metastatic Solid Tumors
Official Title: A PHASE 1 DOSE ESCALATION AND EXPANSION STUDY TO EVALUATE SAFETY, TOLERABILITY, PHARMACOKINETIC, PHARMACODYNAMIC, AND ANTI-TUMOR ACTIVITY OF PF-07209960 IN PARTICIPANTS WITH ADVANCED OR METASTATIC SOLID TUMORS
Study ID: NCT04628780
Brief Summary: This is a first-in-human, Phase 1, open label, multicenter, multiple dose, dose escalation and dose expansion study intended to evaluate the safety, pharmacokinetic, pharmacodynamic, and potential clinical benefit of PF-07209960, an anti-PD-1 targeting IL-15 fusion protein, in participants with selected locally advanced or metastatic solid tumors for whom no standard therapy is available, or would not be an appropriate option in the opinion of the participant and their treating physician, or participants who have refused standard therapy. The study contains 2 parts, single agent Dose Escalation (Part 1) to determine the recommended dose of PF-07209960, followed by Dose Expansion (Part 2) in selected tumor types at the recommended dose.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
City of Hope Investigational Drug Service (IDS), Duarte, California, United States
City of Hope, Duarte, California, United States
Ronald Reagan UCLA Medical Center, Los Angeles, California, United States
UCLA Hematology/Oncology, Los Angeles, California, United States
Santa Monica UCLA Medical Center & Orthopaedic Hospital, Santa Monica, California, United States
UCLA Hematology Oncology - Santa Monica, Santa Monica, California, United States
Tennessee Oncology PLLC, Nashville, Tennessee, United States
The Sarah Cannon Research Institute/Tennessee Oncology, Nashville, Tennessee, United States
TriStar Centennial Medical Center, Nashville, Tennessee, United States
The University of Texas MD Anderson Cancer Center- Investigational Pharmacy, Houston, Texas, United States
The University of Texas MD Anderson Cancer Center, Houston, Texas, United States
Christus Santa Rosa Hospital, San Antonio, Texas, United States
NEXT Oncology, San Antonio, Texas, United States
Name: Pfizer CT.gov Call Center
Affiliation: Pfizer
Role: STUDY_DIRECTOR