New drug hopes to shrink Hard-to-Treat tumors
NCT ID NCT05954312
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-phase study tests a new drug called VVD-130037 in people with advanced solid tumors that have stopped responding to standard treatments. The drug aims to activate a protein (KEAP1) to fight cancer. Researchers will check safety, side effects, and whether the drug works alone or with other cancer drugs. About 290 participants will take part.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 290 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2023
- Expected to finish
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Feb 2031
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Key Inclusion Criteria for Parts 1 and 2: * Histologically or cytologically confirmed metastatic or unresectable solid tumor. * Measurable disease by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as assessed by the Investigator. * Have progressed on or after all prior standard-of-care therapies for metastatic disease. * Eastern Cooperative Oncology Group (ECOG) performance status ≤1. * Adequate organ and marrow function as defined in the protocol. Additional Key Inclusion Criteria for Part 2: * Participants with squamous non-small cell lung cancer (sqNSCLC) with or without nuclear factor erythroid 2-related factor 2 (NRF2 \[NFE2L2\]) and/or cullin 3 (CUL3) mutations. * Participants with advanced sqNSCLC must be refractory to or have progressed on or after a platinum-based doublet regimen and an immune checkpoint inhibitor. * Participants with advanced head and neck squamous cell carcinoma (HNSCC) must have received prior treatment with platinum-based chemotherapy, an immune checkpoint inhibitor (for tumors with known programmed death-ligand 1 \[PD-L1\] expression, microsatellite instability-high, or mismatch repair deficiency, and an anti-epidermal growth factor receptor agent) (Combination Expansion Cohort). * Participants with advanced esophageal squamous cell carcinoma (ESCC) must have received prior treatment with platinum-based chemotherapy, an immune checkpoint inhibitor (for tumors with known PD-L1 expression) (Combination Expansion Cohort). * Participants with a known driver mutation, including activating epidermal growth factor receptor mutations or anaplastic lymphoma kinase rearrangements, should have progressed after appropriate targeted treatment. * Participants with known human epidermal growth factor receptor 2 overexpression should have progressed after appropriate targeted treatment. Key Exclusion Criteria for Parts 1 and 2: * Participant is known to have a mutation that has no expectation of benefit from VVD-130037. Current such mutations include the following: 1. KEAP1 nonsense mutation (any position) 2. KEAP1 frameshift mutation (any position) * Any unresolved toxicity Grade ≥2 per CTCAE version 5.0 from previous anticancer treatment. * Current or prior treatment with anti-epileptic medications for the treatment or prophylaxis of seizures. * History of seizure or condition that may predispose to seizure. * History or presence of central nervous system (CNS) metastases or spinal cord compression. * Uncontrolled arterial hypertension despite optimal medical management. * Risk factors for abnormal heart rhythm/QT prolongation as defined in the protocol. * History of the following cardiac diseases: i) congestive heart failure (New York Heart Association \[NYHA\] Class \>II), ii) unstable angina, iii) new onset angina within past 6 months, iv) myocardial Infarction within the past 6 months, v) clinically significant arrhythmias within past 6 months. * Any prior toxicity (Grade 3 or 4) related to immunotherapy leading to treatment discontinuation (Combination Expansion Cohort) * Medical history of (noninfectious) pneumonitis/interstitial lung disease (ILD), drug induced ILD, radiation pneumonitis that required steroid treatment, or any evidence of clinically active pneumonitis/ILD (Combination Expansion Cohort)
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
26 sites in 3 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Asan Medical Center
RECRUITINGSeoul, South Korea
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Clinica Universitaria de Navarra
RECRUITINGPamplona, Spain
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Florida Cancer Specialists
RECRUITINGSarasota, Florida, 34232, United States
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Gachon University Gil Medical Center
RECRUITINGIncheon, South Korea
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Hospital Clinico Universitario de Valencia
RECRUITINGValencia, Spain
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Hospital Universitario 12 de Octubre
RECRUITINGMadrid, Spain
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Hospital Universitario Ramon y Cajal
RECRUITINGMadrid, Spain
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Hospital Vall d'Hebron
RECRUITINGBarcelona, Spain
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MDACC
RECRUITINGHouston, Texas, 77030, United States
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Mayo Clinic Jacksonville
RECRUITINGJacksonville, Florida, 32224, United States
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Mayo Clinic Rochester
RECRUITINGRochester, Minnesota, 55905, United States
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Moffitt Cancer Center
RECRUITINGTampa, Florida, 33612, United States
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NEXT Dallas
RECRUITINGIrving, Texas, 75039, United States
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NEXT Madrid
RECRUITINGMadrid, Spain
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NEXT Virginia
RECRUITINGFairfax, Virginia, 22031, United States
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National Cancer Center
RECRUITINGGoyang, South Korea
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START Barcelona Hospital HM Nou Delfos
RECRUITINGBarcelona, Spain
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START Madrid CIOCC
RECRUITINGMadrid, Spain
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Samsung Medical Center
RECRUITINGSeoul, South Korea
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Sarah Cannon Research Institute
RECRUITINGNashville, Tennessee, 37203, United States
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Seoul National University Hospital
RECRUITINGSeoul, South Korea
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Seoul National University; Bundang Hospital
RECRUITINGSeongnam, South Korea
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Severance Hospital; Yonsei University Health System
RECRUITINGSeoul, South Korea
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Start Madrid-FJD, Hospital Fundacion Jimenez Diaz
RECRUITINGMadrid, Spain
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The Catholic University of Korea, St. Vincent's Hospital
RECRUITINGGoyang, South Korea
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The Catholic University of Korea, St. Vincent's Hospital
RECRUITINGSuwon, South Korea
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- New PET tracer aims to light up hidden cancer targets
- Can immunotherapy before surgery stop early oral cancer from returning?
- Custom-Built immune cells take aim at a notorious cancer mutation
- Can a glowing dye show surgeons where head and neck tumors end?
- Experimental drug put to the test against Hard-to-Treat GI cancers
- Experimental injection SHR-7787 put to the test against advanced solid tumors