Actively Recruiting
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
Led by Vividion Therapeutics, Inc. · Updated on 2026-05-08
280
Participants Needed
29
Research Sites
174 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
- Microsatellite instability (MSI) and/or deficient mismatch repair (dMMR) advanced solid tumor confirmed by biopsy
- For bevacizumab combination: advanced or metastatic colorectal adenocarcinoma treated with 2-3 prior systemic therapies
- For pembrolizumab combination: locally advanced or metastatic colorectal cancer with no prior metastatic systemic treatment and not suitable for surgery
- Previous progression or intolerance to standard therapy for advanced cancer
- Presence of measurable disease per RECIST version 1.1
- Life expectancy of at least 12 weeks
- Availability of archival tumor tissue or feasible biopsy for testing
- Adequate blood, organ, and heart function as defined in the protocol
You will not qualify if you...
- Unable or unwilling to swallow pills
- Conditions affecting absorption of oral medication
- Known allergy or intolerance to study drug ingredients, including rare genetic disorders like galactosaemia
- Uncontrolled central nervous system metastases or carcinomatous meningitis
- Active or uncontrolled infections requiring recent intravenous antibiotics or hospitalization
- Positive test for hepatitis B, hepatitis C, or HIV at screening
- Uncontrolled diabetes or symptomatic high blood sugar
- Significant cardiovascular or cerebrovascular disease within 6 months prior to study start
- Alcohol or drug dependence or abuse
- Known Werner (WRN) syndrome
- Previous treatment with any WRN helicase inhibitor
- Treatment with moderate or strong CYP3A4 inducers or inhibitors within 14 days before study start
- Pregnancy, breastfeeding, or planning pregnancy during the study
- For bevacizumab group: major surgery within 4 weeks prior to study drug, recent deep vein thrombosis or pulmonary embolism, bleeding risk disorders, or Grade 2+ proteinuria except if urinary protein is less than 1.0 gm/24 hours
- For pembrolizumab group: active or past autoimmune disease or immune deficiency with exceptions, history of interstitial lung disease or pneumonitis, recent systemic immunosuppressive treatment with exceptions, or organ transplant history
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 29 locations
1
City of Hope Cancer Center
Duarte, California, United States, 91010
Actively Recruiting
2
City of Hope at Irvine Lennar
Irvine, California, United States, 91355
Actively Recruiting
3
Emory University School of Medicine
Atlanta, Georgia, United States, 30322
Actively Recruiting
4
Norton Cancer Institute - MDC
Louisville, Kentucky, United States, 40202
Actively Recruiting
5
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States, 08901
Actively Recruiting
6
Duke University
Durham, North Carolina, United States, 27705
Completed
7
Oklahoma University Health Sciences Center
Oklahoma City, Oklahoma, United States, 73170
Actively Recruiting
8
SCRI Oncology Partners
Nashville, Tennessee, United States, 37203
Actively Recruiting
9
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
10
St Vincents Sydney
Darlinghurst, New South Wales, Australia, 2010
Active, Not Recruiting
11
Alfred Hospital
Melbourne, Victoria, Australia, 3181
Actively Recruiting
12
UZ Leuven Gasthuisberg
Leuven, Belgium, 3000
Active, Not Recruiting
13
BCCA-Vancouver Cancer Centre
Vancouver, British Columbia, Canada, V5Z 4E6
Completed
14
Princess Margaret Cancer Center
Toronto, Ontario, Canada, M5G 2M9
Active, Not Recruiting
15
Rigshospitalet
København Ø, Denmark, 2100
Active, Not Recruiting
16
CLCC Leon Berard Lyon
Lyon, France, 69008
Completed
17
Gustave Roussy
Villejuif, France, 94805
Active, Not Recruiting
18
Sarawak Public Hospital
Kuching, Sarawak, Malaysia, 93586
Active, Not Recruiting
19
Seoul National University Bundang Hospital
Seongnam-si, South Korea, 13620
Active, Not Recruiting
20
Seoul National University Hospital
Seoul, South Korea, 03080
Active, Not Recruiting
21
Asan Medical Center
Seoul, South Korea, 05505
Active, Not Recruiting
22
Vall d'Hebron Institute of Oncology (VHIO), Barcelona
Barcelona, BARCELONA, Spain, 08035
Active, Not Recruiting
23
Clinica Universidad de Navarra Madrid
Madrid, Madrid, Spain, 28027
Active, Not Recruiting
24
START Madrid. Centro Integral Oncologico Clara Campal
Madrid, Madrid, Spain, 28050
Active, Not Recruiting
25
Clinica Universitaria de Navarra
Pamplona, Navarre, Spain, 31008
Active, Not Recruiting
26
Hospital Clinico Universitario de Valencia
Valencia, Valencia, Spain, 46010
Active, Not Recruiting
27
Sarah Cannon Research Institute
London, United Kingdom, W1G 6AD
Actively Recruiting
28
The Christie
Manchester, United Kingdom, M20 4BX
Active, Not Recruiting
29
Royal Marsden Hospital (Sutton)
Sutton, United Kingdom, SM2 5PT
Active, Not Recruiting
Research Team
V
Vividion Clinical Trial Call Center
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
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