A Study to Evaluate the Safety, Pharmacokinetics, and Anti-Tumor Activity of VVD-133214 as Monotherapy and in Combination With Pembrolizumab in Participants With Advanced Solid Tumors
NCT ID: NCT06004245
Last Updated: 2025-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
295 participants
INTERVENTIONAL
2024-01-25
2027-05-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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VVD-133214 Dose Escalation
VVD-133214
VVD-133214 will be administered orally and once daily (QD) in 3-week cycles.
VVD-133214 Monotherapy Expansion
VVD-133214
VVD-133214 will be administered orally and once daily (QD) in 3-week cycles.
VVD-133214 + Pembrolizumab Expansion
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 pembrolizumab only: Histologically confirmed locally advanced, or metastatic colorectal adenocarcinoma (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
Exclusion Criteria
* Malabsorption syndrome or other condition that would interfere with enteral absorption
* Known hypersensitivity or intolerance to ingredients from the study drug formulation including patients with rare genetic disorders such as galactosaemia, glucose-galactose intolerance or congenital lactase deficiency
* Known uncontrolled central nervous system (CNS) metastases (progressing or requiring anticonvulsants or corticosteroids for symptomatic control) and/or carcinomatous meningitis
* Known active or uncontrolled bacterial, viral, fungal, mycobacterial (including but not limited to tuberculosis and atypical mycobacterial disease), parasitic, or other infection (excluding fungal infections of nail beds), or any major episode of infection requiring treatment with intravenous antibiotics or hospitalization within 2 weeks prior to the start of drug administration (related to the completion of the course of antibiotics, except if for tumor fever) or 6 months for any intracranial abscess
* Has a positive test at screening for hepatitis B virus, hepatitis C virus, or for human immodeficiency virus (HIV), per local diagnostic standard and in accordance with local laws and regulations
* Uncontrolled diabetes or symptomatic hyperglycemia (i.e., well controlled defined as a screening hemoglobin A1c \<8% and no urinary ketoacidosis)
* Significant cardiovascular/cerebrovascular disease within 6 months prior to Day 1 of study drug administration
* Alcohol or drug dependence or abuse
* Patients with known Werner (WRN) syndrome
* Prior treatment with any WRN helicase inhibitor
* Treatment with moderate or strong CYP3A4 inducers within 14 days prior to initiation of study treatment
* Treatment with moderate or strong CYP3A4 or P-glycoprotein inhibitors within 14 days prior to initiation of study treatment
* Pregnancy, breastfeeding, or intention of becoming pregnant during the study
* Active or history of autoimmune disease or immune deficiency with some exceptions
* History of interstitial lung disease or pneumonitis
* Treatment with systemic immunosuppressive medication (such as corticosteroids) within 2 weeks prior to initiation of study treatment with some exceptions
* Treatment with organ transplant/graft tissue
18 Years
ALL
No
Sponsors
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Vividion Therapeutics, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Vividion Therapeutics
Locations
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City of Hope Cancer Center
Duarte, California, United States
City of Hope - Santa Clarita
Valencia, California, United States
Norton Cancer Institute - MDC
Louisville, Kentucky, 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
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
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
Countries
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Central Contacts
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Vividion Clinical Trial Call Center
Role: CONTACT
Phone: 1+ 858-345-9752 (U.S. Only)
Email: [email protected]
Other Identifiers
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2023-503170-20-01
Identifier Type: REGISTRY
Identifier Source: secondary_id
VVD-133214-01
Identifier Type: -
Identifier Source: org_study_id