SRK-181 Alone or in Combination With Anti-PD-(L)1 Antibody Therapy in Patients With Locally Advanced or Metastatic Solid Tumors (DRAGON)

Completed · Phase 1

Conditions studied: Cancer

In brief

This was a multi-center, open-label, Phase 1, first-in-human (FIH), dose-escalation, and dose expansion study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and efficacy of SRK-181 administered alone and in combination with anti-PD-(L)1 therapy in adult patients with locally advanced or metastatic solid tumors. The study was divided into 3 treatment parts (Part A1, Part A2, and Part B) and a Long-Term Extension Phase (LTEP).

Key facts

Study ID

NCT04291079

Run by

Scholar Rock, Inc.

People needed

112

Starts

2020-04-23

Expected to finish

2025-04-14

Last updated by the study team

2025-04-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

Where it is running

• St. Jude Crosson Cancer Institute — Fullerton, California, United States
• University of California - San Diego — La Jolla, California, United States
• The Oncology Institute — Los Angeles, California, United States
• Hoag Memorial Hospital Presbyterian — Newport Beach, California, United States
• Advent Health — Celebration, Florida, United States
• Memorial Cancer Institute - South Broward Hospital District — Hollywood, Florida, United States
• H. Lee Moffitt Cancer Center& Research Institute — Tampa, Florida, United States
• University of Chicago — Chicago, Illinois, United States
• Fort Wayne Medical Oncology and Hematology, Inc — Fort Wayne, Indiana, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• University of Michigan — Ann Arbor, Michigan, United States
• Henry Ford Cancer Institute — Detroit, Michigan, United States
• Stony Brook University Cancer Center — Stony Brook, New York, United States
• Tennessee Oncology, Sarah Cannon Research Institute — Nashville, Tennessee, United States
• BUMC Mary Crowley Cancer Research Centers — Dallas, Texas, United States
• The University of Texas - MD Anderson Cancer Center — Houston, Texas, United States
• Medical College of Wisconsin — Milwaukee, Wisconsin, United States
• Korea University Ansan Hospital — Ansan-si, South Korea
• Seoul National University - Bundang Hospital — Seongnam-si, South Korea
• Korea University Anam Hospital — Seoul, South Korea
• Seoul National University Hospital — Seoul, South Korea

Full record on ClinicalTrials.gov

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