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Brief Title: Study of CTX-471 as a Monotherapy or in Combination With Pembrolizumab in Patients Post PD-1/PD-L1 Inhibitors in Metastatic or Locally Advanced Malignancies
Official Title: A Phase 1, Open-Label, Multiple-Ascending Dose Study of the Safety and Tolerability of CTX-471 Administered Either as a Monotherapy or in Combination With Pembrolizumab in Patients With Inadequate Responses to PD-1/PD-L1 Checkpoint Inhibitors in Metastatic or Locally Advanced Malignancies
Study ID: NCT03881488
Brief Summary: This is a Phase 1, open-label, first-in-human study of CTX-471 administered as a monotherapy or in combination with pembrolizumab in patients with metastatic or locally advanced malignancies that have progressed while receiving an approved PD-1 or PD-L1 inhibitor. The study will be conducted in 2 treatment arms (Monotherapy Arm 1 and Combination Arm 2). Each arm will have two parts: Part 1 Dose Escalation and Part 2 Dose Expansion.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Ocala Oncology Center, Ocala, Florida, United States
Hematology Oncology Associates Of The Treasure Coast, Port Saint Lucie, Florida, United States
Massachusetts General Hospital, Boston, Massachusetts, United States
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
Washington University School of Medicine, Siteman Cancer Center, Saint Louis, Missouri, United States
Hackensack University Medical Center, Hackensack, New Jersey, United States
Mt Sinai, New York, New York, United States
Duke University School of Medicine, Durham, North Carolina, United States
Institute for Translational Oncology Research (ITOR), Greenville, South Carolina, United States
Mary Crowley Cancer Research, Dallas, Texas, United States
Name: Thomas Scheutz, MD, PhD
Affiliation: Compass Therapeutics
Role: STUDY_DIRECTOR