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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
Sponsor: Vividion Therapeutics, Inc.
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.
Official title: A Phase I, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Anti-Tumor Activity of VVD-133214 as Monotherapy and in Combination in Participants With Advanced Solid Tumors Harboring Microsatellite Instability (MSI) and/or Deficient Mismatch Repair (dMMR)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
280
Start Date
2024-01-25
Completion Date
2027-05-31
Last Updated
2026-04-07
Healthy Volunteers
No
Conditions
Interventions
VVD-133214
VVD-133214 will be administered orally and once daily (QD) in 3-week cycles.
Pembrolizumab
Pembrolizumab will be administered by intravenous (IV) infusion at a fixed dose of 200 mg on Day 1 of each 21-day cycle.
Bevacizumab
Bevacizumab will be administered by intravenous (IV) infusion at a fixed dose of 7.5 mg/kg on Day 1 of each 21-day cycle.
Locations (29)
City of Hope Cancer Center
Duarte, California, United States
City of Hope at Irvine Lennar
Irvine, California, United States
Emory University School of Medicine
Atlanta, Georgia, United States
Norton Cancer Institute - MDC
Louisville, Kentucky, United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States
Duke University
Durham, North Carolina, United States
Oklahoma University Health Sciences Center
Oklahoma City, Oklahoma, United States
SCRI Oncology Partners
Nashville, Tennessee, United States
MD Anderson Cancer Center
Houston, Texas, United States
St Vincents Sydney
Darlinghurst, New South Wales, Australia
Alfred Hospital
Melbourne, Victoria, Australia
UZ Leuven Gasthuisberg
Leuven, Belgium
BCCA-Vancouver Cancer Centre
Vancouver, British Columbia, Canada
Princess Margaret Cancer Center
Toronto, Ontario, Canada
Rigshospitalet
København Ø, Denmark
CLCC Leon Berard Lyon
Lyon, France
Gustave Roussy
Villejuif, France
Sarawak Public Hospital
Kuching, Sarawak, Malaysia
Seoul National University Bundang Hospital
Seongnam-si, South Korea
Seoul National University Hospital
Seoul, South Korea
Asan Medical Center
Seoul, South Korea
Vall d'Hebron Institute of Oncology (VHIO), Barcelona
Barcelona, BARCELONA, Spain
Clinica Universidad de Navarra Madrid
Madrid, Madrid, Spain
START Madrid. Centro Integral Oncologico Clara Campal
Madrid, Madrid, Spain
Clinica Universitaria de Navarra
Pamplona, Navarre, Spain
Hospital Clinico Universitario de Valencia
Valencia, Valencia, Spain
Sarah Cannon Research Institute
London, United Kingdom
The Christie
Manchester, United Kingdom
Royal Marsden Hospital (Sutton)
Sutton, United Kingdom