Study of VVD-133214 for Advanced Solid Tumors
This study is testing a new oral drug called VVD-133214, by itself and in combination with other approved cancer medicines (Pembrolizumab or Bevacizumab), for people with advanced solid tumors. VVD-133214 works by targeting a protein called Werner (WRN) that may help certain cancers grow. The study is looking at how safe these treatments are, how your body handles VVD-133214, and if they can shrink tumors. To join, you must have advanced solid tumors with specific genetic markers called microsatellite instability (MSI) and/or deficient mismatch repair (dMMR). For the combination with Bevacizumab, you must have advanced colorectal cancer. The main goals are to track side effects and see how well the treatments are tolerated.
- Study design
- This is a Phase 1, open-label study, meaning both you and your doctors will know which treatment you are receiving. It aims to enroll about 280 participants.
- What's involved
- VVD-133214 is taken by mouth once daily in 3-week cycles. Pembrolizumab and Bevacizumab are given through an IV infusion on Day 1 of each 21-day cycle.
- Compensation
- Not stated in the trial record.
- Follow-up
- You will be monitored for side effects for at least 30 days after your last dose of VVD-133214, or 90 days after your last dose of Pembrolizumab or Bevacizumab.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT06004245
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
Recruiting
PHASE1Ages 18+InterventionalTreatmentVividion Therapeutics, Inc.
~280 participants
Updated 2026-08-17 on ClinicalTrials.gov
What's tested:VVD-133214PembrolizumabBevacizumab
At a glance
Recruiting sites
28 of 43 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of Adverse Events, with Severity Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0 (NCI CTCAE v5.0)
Measured over From first dose of study drug(s) until 30 days after the final dose of VVD-133214 or 90 days after last dose of bevacizumab or pembrolizumab
+1 more outcome measured
Conditions
Where it's being run
43 sites across 28 statesSouth Korea7
California3
United Kingdom3
Michigan2
Texas2
China2
France2
Madrid2
Study leadership
- Clinical Trials · STUDY_DIRECTOR · Vividion Therapeutics
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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
Exclusion
Inability or unwillingness to swallow pills
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
Had major surgery within 4 weeks prior to study drug administration
Deep venous thrombosis (DVT) or pulmonary embolism (PE) within 12 weeks prior to study drug administration
Known coagulopathy that increases the risk of bleeding
Patients with Grade 2+ proteinuria (exception: if 24-hour urinary protein is less than 1.0 gm/24 hours)
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
What this trial measures
- Incidence of Adverse Events, with Severity Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0 (NCI CTCAE v5.0)From first dose of study drug(s) until 30 days after the final dose of VVD-133214 or 90 days after last dose of bevacizumab or pembrolizumab
- Incidence of Dose-Limiting ToxicitiesCycle 1 (1 cycle is 3 weeks)