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RECRUITING
NCT06004245
PHASE1

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

Sponsor: 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 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.

Official title: 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)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

280

Start Date

2024-01-25

Completion Date

2027-05-31

Last Updated

2026-04-07

Healthy Volunteers

No

Interventions

DRUG

VVD-133214

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

DRUG

Pembrolizumab

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

DRUG

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.

Locations (29)

City of Hope Cancer Center

Duarte, California, United States

City of Hope at Irvine Lennar

Irvine, California, United States

Emory University School of Medicine

Atlanta, Georgia, United States

Norton Cancer Institute - MDC

Louisville, Kentucky, 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

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

Rigshospitalet

København Ø, Denmark

CLCC Leon Berard Lyon

Lyon, France

Gustave Roussy

Villejuif, France

Sarawak Public Hospital

Kuching, Sarawak, Malaysia

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