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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 | Clinical Trials | Clareo Health

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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

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 With Pembrolizumab in Participants With Advanced Solid Tumors Harboring Microsatellite Instability (MSI) and/or Deficient Mismatch Repair (dMMR)

NCT06004245•Vividion Therapeutics, Inc.

View on ClinicalTrials.gov

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 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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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 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

•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
+8 more criteria

Locations (25)

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

Key Dates

Start Date

January 25, 2024

Primary Completion Date

May 31, 2027

Completion Date

May 31, 2027

Last Updated

February 17, 2026

Enrollment

295

ESTIMATED participants

Conditions

Advanced Solid Tumors

Interventions

VVD-133214

DRUG

Pembrolizumab

DRUG

Contacts

Vividion Clinical Trial Call Center

CONTACT

1+ 858-345-9752 (U.S. Only)clinicaltrials@vividion.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 17, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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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

Inclusion Criteria

Exclusion Criteria

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