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Brief Title: Phase I Dose Escalation Study for VIP152 in Patients With Advanced Cancer
Official Title: An Open-label, Multicenter Phase I Dose Escalation Study to Characterize Safety, Tolerability, Preliminary Anti-tumor Activity, Pharmacokinetics and Maximum Tolerated Dose of VIP152 (BAY 1251152) as Monotherapy or Combination Therapy in Subjects With Advanced Cancer.
Study ID: NCT02635672
Brief Summary: Determine the safety, tolerability, pharmacokinetics, maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of VIP152 (BAY 1251152) as monotherapy or in combination in patients with solid tumors and aggressive non-hodgkin's lymphoma (NHL).
Detailed Description: Part 2 VIP152 Monotherapy (Global). Part 3 dose escalation with VIP152 in combination with pembrolizumab (US only). Part 4 dose expansion with VIP152 in combination with pembrolizumab (US only).
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Highlands Oncology Group, Springdale, Arkansas, United States
Norton Cancer Institute, Louisville, Kentucky, United States
Maryland Oncology Hematology, Silver Spring, Maryland, United States
John Theurer Cancer Center, Hackensack, New Jersey, United States
Memorial Sloan Kettering Cancer Center, New York, New York, United States
University of Cincinnati Medical Center, Cincinnati, Ohio, United States
Willamette Valley Cancer Institute, Eugene, Oregon, United States
Oregon Health and Science University, Portland, Oregon, United States
Avera Health, Sioux Falls, South Dakota, United States
Sarah Cannon Research Institute, Nashville, Tennessee, United States
NEXT Oncology, Austin, Texas, United States
University of Texas MD Anderson Cancer Center, Houston, Texas, United States
NEXT Oncology, San Antonio, Texas, United States
Centro de Investigaciones Clínicas Viña del Mar, Viña Del Mar, Valparaíso, Chile
Oncocentro, Viña del Mar, , Chile
START Madrid- Fundación Jiménez Diaz, Madrid, , Spain
Name: Vincerx Study Director
Affiliation: Vincerx Pharma, Inc.
Role: STUDY_DIRECTOR