A First-in-Human (FIH) Study to Evaluate the Safety and Tolerability of VVD-130037 in Participants With Advanced Solid Tumors
A Phase 1, Open-label, Multicenter, First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Anti-tumor Activity of VVD-130037, a Kelch-like ECH Associated Protein 1 (KEAP1) Activator, in Participants With Advanced Solid Tumors
A FIH dose escalation and dose expansion study to evaluate VVD-130037 in participants with advanced solid tumors as a single agent, and in combination with docetaxel, paclitaxel, or pembrolizumab.
Eligibility
Min Age: 18 Years
Plain Language Summary
Simplified for easier understanding
This early-phase study is testing a new experimental cancer drug called VVD-130037 in people with advanced solid tumors that have not responded to standard treatments. This is the first time this drug is being tested in humans, so the study focuses primarily on safety and finding the right dose.
**You may be eligible if...**
- You have confirmed advanced or metastatic solid tumor that has progressed on all prior standard treatments
- You have at least one measurable tumor on imaging
- Your overall health is adequate (ECOG ≤1) with good organ function
- For certain cohorts: You may need to have squamous cell lung cancer, head and neck cancer, or esophageal squamous cell cancer with specific prior treatments
**You may NOT be eligible if...**
- You have specific genetic mutations (KEAP1 nonsense or frameshift mutations) that are expected to prevent benefit from this drug
- You are on anti-epileptic medications or have a history of seizures
- Your cancer has spread to the brain or spinal cord
- You have had a recent heart attack, congestive heart failure, or serious irregular heartbeat in the past 6 months
- You have unresolved significant toxicity from prior cancer treatment
Talk to your doctor to see if this trial is right for you.
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-130037
Oral tablets
DRUGDocetaxel
IV infusion
DRUGPaclitaxel
IV infusion
DRUGPembrolizumab
IV infusion
Locations(26)
Mayo Clinic Jacksonville
Jacksonville, Florida, United States
Florida Cancer Specialists
Sarasota, Florida, United States
Moffitt Cancer Center
Tampa, Florida, United States
Mayo Clinic Rochester
Rochester, Minnesota, United States
Sarah Cannon Research Institute
Nashville, Tennessee, United States
MDACC
Houston, Texas, United States
NEXT Dallas
Irving, Texas, United States
NEXT Virginia
Fairfax, Virginia, United States
National Cancer Center
Goyang, South Korea
The Catholic University of Korea, St. Vincent's Hospital
Goyang, South Korea
Gachon University Gil Medical Center
Incheon, South Korea
Seoul National University; Bundang Hospital
Seongnam, South Korea
Asan Medical Center
Seoul, South Korea
Samsung Medical Center
Seoul, South Korea
Seoul National University Hospital
Seoul, South Korea
Severance Hospital; Yonsei University Health System
Seoul, South Korea
The Catholic University of Korea, St. Vincent's Hospital
Suwon, South Korea
Hospital Vall d'Hebron
Barcelona, Spain
START Barcelona Hospital HM Nou Delfos
Barcelona, Spain
Hospital Universitario 12 de Octubre
Madrid, Spain
Hospital Universitario Ramon y Cajal
Madrid, Spain
NEXT Madrid
Madrid, Spain
START Madrid CIOCC
Madrid, Spain
Start Madrid-FJD, Hospital Fundacion Jimenez Diaz
Madrid, Spain
Clinica Universitaria de Navarra
Pamplona, Spain
Hospital Clinico Universitario de Valencia
Valencia, Spain
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.