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Clinical Trials in the USA / NCT06004245
Recruiting Phase 1

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

NCT06004245 · tracked via the Priya Life Science USA tracker
Sponsor
Vividion Therapeutics, Inc.
Phase
Phase 1
Started
2024-01-25
Last updated
2026-09-18

Condition(s) studied

Advanced Solid TumorsColorectal Cancer

Investigational drug(s) / intervention(s)

VVD-133214PembrolizumabBevacizumab

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.

Bevacizumab: Bevacizumab will be administered by intravenous (IV) infusion at a fixed dose of 7.5 mg/kg on Day 1 of each 21-day cycle.

Study 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

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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 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 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 * 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 Additional Exclusion Criteria for the Combination with Bevacizumab Only: * 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) Additional Exclusion Criteria for the Combination with Pembrolizumab Only: * 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

Primary outcome measure(s)

Trial sites (47)

FacilityCityRegionStatus
University of Arizona Cancer Center Tucson Arizona Not Yet Recruiting
City of Hope Cancer Center Duarte California Recruiting
City of Hope at Irvine Lennar Irvine California Recruiting
START Los Angeles Los Angeles California Recruiting
Emory University School of Medicine Atlanta Georgia Recruiting
University of Chicago Chicago Illinois Not Yet Recruiting
Norton Cancer Institute - MDC Louisville Kentucky Recruiting
University of Michigan Ann Arbor Michigan Recruiting
START Midwest Grand Rapids Michigan Recruiting
Rutgers Cancer Institute of New Jersey New Brunswick New Jersey Recruiting
Duke University Durham North Carolina Completed
Oklahoma University Health Sciences Center Oklahoma City Oklahoma Active Not Recruiting
SCRI Oncology Partners Nashville Tennessee Recruiting
MD Anderson Cancer Center Houston Texas Recruiting
START San Antonio San Antonio Texas Recruiting
START Mountain Region West Valley City Utah Recruiting
St Vincents Sydney Darlinghurst New South Wales Recruiting
Alfred Hospital Melbourne Victoria Recruiting
UZ Leuven Gasthuisberg Leuven Belgium Recruiting
BCCA-Vancouver Cancer Centre Vancouver British Columbia Completed
Princess Margaret Cancer Center Toronto Ontario Recruiting
Zhejiang Cancer Hospital Hangzhou Zhejiang Not Yet Recruiting
Beijing Cancer Hospital Beijing China Recruiting
The Sixth Hospital, affiliated with Sun Yat-sen University Guangzhou China Not Yet Recruiting
Rigshospitalet København Ø Denmark Recruiting
CLCC Leon Berard Lyon Lyon France Completed
Gustave Roussy Villejuif France Recruiting
Sarawak Public Hospital Kuching Sarawak Recruiting
Kyungpook National University Chilgok Hospital Daegu South Korea Not Yet Recruiting
National Cancer Center Gyeonggi-do South Korea Not Yet Recruiting
Seoul National University Bundang Hospital Seongnam-si South Korea Recruiting
Seoul National University Hospital Seoul South Korea Recruiting
Asan Medical Center Seoul South Korea Active Not Recruiting
Samsung Medical Center Seoul South Korea Recruiting
Severance Hospital Seoul South Korea Recruiting
Vall d'Hebron Institute of Oncology (VHIO), Barcelona Barcelona BARCELONA Recruiting
Clinica Universidad de Navarra Madrid Madrid Madrid Recruiting
START Madrid. Centro Integral Oncologico Clara Campal Madrid Madrid Recruiting
Clinica Universitaria de Navarra Pamplona Navarre Recruiting
Hospital Clinico Universitario de Valencia Valencia Valencia Recruiting

+ 7 more sites — see the full list on the official registry below.

On this site

📄 Keytruda (pembrolizumab) drug profile → 📄 Avastin (bevacizumab) drug profile →

More Vividion Therapeutics, Inc. trials in the USA

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06004245 on ClinicalTrials.gov ↗ ← All trials in the USA