A Study to Evaluate the Safety, Pharmacokinetics, and Anti-Tumor Activity of VVD-133214 as Monotherapy and in Combination in Participants With Advanced Solid Tumors
Start Date
1/25/2024
Completion Date
5/31/2027
Summary
This is a first-in-human, Phase I, open-label, multicenter, dose-escalation and dose expansion study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of VVD-133214 monotherapy, and in combination with bevacizumab or pembrolizumab, in participants with microsatellite instability (MSI) and/or deficient mismatch repair (dMMR) advanced solid tumors. VVD-133214 is an oral drug that acts on a protein called Werner (WRN), which may promote the growth of cancers that are MSI and/or dMMR. By acting on WRN, VVD-133214 may be able to block the growth of these types of cancer.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
VVD-133214
Pembrolizumab
Bevacizumab
Conditions
Locations
City of Hope Cancer Center
Duarte, California 91010
United States
City of Hope at Irvine Lennar
Irvine, California 91355
United States
START Los Angeles
Los Angeles, California 90025
United States
Emory University School of Medicine
Atlanta, Georgia 30322
United States
Norton Cancer Institute - MDC
Louisville, Kentucky 40202
United States
University of Michigan
Ann Arbor, Michigan 48109
United States
START Midwest
Grand Rapids, Michigan 49546
United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey 08901
United States
Duke University
Durham, North Carolina 27705
United States
Oklahoma University Health Sciences Center
Oklahoma City, Oklahoma 73170
United States
SCRI Oncology Partners
Nashville, Tennessee 37203
United States
MD Anderson Cancer Center
Houston, Texas 77030
United States
START San Antonio
San Antonio, Texas 78229
United States
START Mountain Region
West Valley City, Utah 84119
United States
St Vincents Sydney
Darlinghurst, New South Wales 2010
Australia
Alfred Hospital
Melbourne, Victoria 3181
Australia
UZ Leuven Gasthuisberg
Leuven, 3000
Belgium
BCCA-Vancouver Cancer Centre
Vancouver, British Columbia V5Z 4E6
Canada
Princess Margaret Cancer Center
Toronto, Ontario M5G 2M9
Canada
Rigshospitalet
København Ø, 2100
Denmark
CLCC Leon Berard Lyon
Lyon, 69008
France
Gustave Roussy
Villejuif, 94805
France
Sarawak Public Hospital
Kuching, Sarawak 93586
Malaysia
Kyungpook National University Chilgok Hospital
Daegu, 41404
South Korea
National Cancer Center
Gyeonggi-do, 10408
South Korea
Seoul National University Bundang Hospital
Seongnam-si, 13620
South Korea
Seoul National University Hospital
Seoul, 03080
South Korea
Asan Medical Center
Seoul, 05505
South Korea
Samsung Medical Center
Seoul, 06355
South Korea
Severance Hospital
Seoul, 33732
South Korea
Vall d'Hebron Institute of Oncology (VHIO), Barcelona
Barcelona, BARCELONA 08035
Spain
Clinica Universidad de Navarra Madrid
Madrid, Madrid 28027
Spain
START Madrid. Centro Integral Oncologico Clara Campal
Madrid, Madrid 28050
Spain
Clinica Universitaria de Navarra
Pamplona, Navarre 31008
Spain
Hospital Clinico Universitario de Valencia
Valencia, Valencia 46010
Spain
Sarah Cannon Research Institute
London, W1G 6AD
United Kingdom
The Christie
Manchester, M20 4BX
United Kingdom
Royal Marsden Hospital (Sutton)
Sutton, SM2 5PT
United Kingdom