RecruitingPhase 1NCT06004245

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

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


Sponsor

Vividion Therapeutics, Inc.

Enrollment

280 participants

Start Date

Jan 25, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Bevacizumab, a drug called Pembrolizumab, and others for people with advanced solid tumors and colorectal, cancer. The study is currently recruiting participants at 29 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGVVD-133214

VVD-133214 will be administered orally and once daily (QD) in 3-week cycles.

DRUGPembrolizumab

Pembrolizumab will be administered by intravenous (IV) infusion at a fixed dose of 200 mg on Day 1 of each 21-day cycle.

DRUGBevacizumab

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.


Locations(47)

University of Arizona Cancer Center

Tucson, Arizona, United States

City of Hope Cancer Center

Duarte, California, United States

City of Hope at Irvine Lennar

Irvine, California, United States

START Los Angeles

Los Angeles, California, United States

Emory University School of Medicine

Atlanta, Georgia, United States

University of Chicago

Chicago, Illinois, United States

Norton Cancer Institute - MDC

Louisville, Kentucky, United States

University of Michigan

Ann Arbor, Michigan, United States

START Midwest

Grand Rapids, Michigan, United States

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, 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

START San Antonio

San Antonio, Texas, United States

START Mountain Region

West Valley City, Utah, United States

St Vincents Sydney

Darlinghurst, New South Wales, Australia

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

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

Beijing Cancer Hospital

Beijing, China

The Sixth Hospital, affiliated with Sun Yat-sen University

Guangzhou, China

Rigshospitalet

København Ø, Denmark

CLCC Leon Berard Lyon

Lyon, France

Gustave Roussy

Villejuif, France

Sarawak Public Hospital

Kuching, Sarawak, Malaysia

Kyungpook National University Chilgok Hospital

Daegu, South Korea

National Cancer Center

Gyeonggi-do, South Korea

Seoul National University Bundang Hospital

Seongnam-si, South Korea

Seoul National University Hospital

Seoul, South Korea

Asan Medical Center

Seoul, South Korea

Samsung Medical Center

Seoul, South Korea

Severance Hospital

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

NEXT Oncology - Barcelona

Barcelona, Spain

START Barcelona

Barcelona, Spain

Start Madrid-FJD, Hospital Fundacion Jimenez Diaz

Madrid, Spain

NEXT Oncology-Hospital Universitario Quironsalud Madrid

Madrid, Spain

Sarah Cannon Research Institute

London, United Kingdom

The Christie

Manchester, United Kingdom

Royal Marsden Hospital (Sutton)

Sutton, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT06004245


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