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)
Status: Recruiting
Location: See all (43) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
• Have a microsatellite instability (MSI) and/or deficient mismatch repair (dMMR), histologically or cytologically documented advanced (unresectable and/or metastatic) solid tumor; For the combination with bevacizumab only: advanced, or metastatic colorectal adenocarcinoma (CRC) treated with at least 2 but no more than 3 prior lines of systemic therapy for the treatment of advanced CRC; For the combination with pembrolizumab only: Histologically confirmed locally advanced, or metastatic CRC with no prior systemic treatment for metastatic disease and not amenable to surgery
• Have received and then progressed following, or are intolerant to, standard therapy in the advanced setting
• Presence of measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
• Life expectancy of at least (≥)12 weeks
• Availability of formaldehyde-fixed paraffin-embedded (FFPE) archival tumor tissue for submission to Sponsor/central laboratory for retrospective central testing; for participants without archival tissue, a biopsy from either primary or metastatic tumor lesion, deemed medically feasible, must be taken
• Adequate hematologic, end-organ, and cardiovascular function, as defined in the protocol
Locations
United States
Arizona
University of Arizona Cancer Center
NOT_YET_RECRUITING
Tucson
California
City of Hope Cancer Center
RECRUITING
Duarte
City of Hope at Irvine Lennar
RECRUITING
Irvine
START Los Angeles
RECRUITING
Los Angeles
Georgia
Emory University School of Medicine
RECRUITING
Atlanta
Illinois
University of Chicago
NOT_YET_RECRUITING
Chicago
Kentucky
Norton Cancer Institute - MDC
RECRUITING
Louisville
Michigan
University of Michigan
RECRUITING
Ann Arbor
START Midwest
RECRUITING
Grand Rapids
North Carolina
Duke University
COMPLETED
Durham
New Jersey
Rutgers Cancer Institute of New Jersey
RECRUITING
New Brunswick
Oklahoma
Oklahoma University Health Sciences Center
RECRUITING
Oklahoma City
Tennessee
SCRI Oncology Partners
RECRUITING
Nashville
Texas
MD Anderson Cancer Center
RECRUITING
Houston
START San Antonio
RECRUITING
San Antonio
Utah
START Mountain Region
RECRUITING
West Valley City
Other Locations
Australia
St Vincents Sydney
RECRUITING
Darlinghurst
Alfred Hospital
RECRUITING
Melbourne
Belgium
UZ Leuven Gasthuisberg
RECRUITING
Leuven
Canada
Princess Margaret Cancer Center
RECRUITING
Toronto
BCCA-Vancouver Cancer Centre
COMPLETED
Vancouver
China
Beijing Cancer Hospital
NOT_YET_RECRUITING
Beijing
The Sixth Hospital, affiliated with Sun Yat-sen University
NOT_YET_RECRUITING
Guangzhou
Zhejiang Cancer Hospital
NOT_YET_RECRUITING
Hangzhou
Denmark
Rigshospitalet
RECRUITING
København Ø
France
CLCC Leon Berard Lyon
COMPLETED
Lyon
Gustave Roussy
RECRUITING
Villejuif
Malaysia
Sarawak Public Hospital
RECRUITING
Kuching
Republic of Korea
Kyungpook National University Chilgok Hospital
NOT_YET_RECRUITING
Daegu
National Cancer Center
NOT_YET_RECRUITING
Gyeonggi-do
Seoul National University Bundang Hospital
RECRUITING
Seongnam-si
Asan Medical Center
ACTIVE_NOT_RECRUITING
Seoul
Samsung Medical Center
NOT_YET_RECRUITING
Seoul
Seoul National University Hospital
RECRUITING
Seoul
Severance Hospital
NOT_YET_RECRUITING
Seoul
Spain
Vall d'Hebron Institute of Oncology (VHIO), Barcelona
RECRUITING
Barcelona
Clinica Universidad de Navarra Madrid
RECRUITING
Madrid
START Madrid. Centro Integral Oncologico Clara Campal