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New drug hopes to shrink Hard-to-Treat tumors

NCT ID NCT05954312

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 290 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2023

Expected to finish

Feb 2031

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    26 sites in 3 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Asan Medical Center

    RECRUITING

    Seoul, South Korea

  • Clinica Universitaria de Navarra

    RECRUITING

    Pamplona, Spain

  • Florida Cancer Specialists

    RECRUITING

    Sarasota, Florida, 34232, United States

  • Gachon University Gil Medical Center

    RECRUITING

    Incheon, South Korea

  • Hospital Clinico Universitario de Valencia

    RECRUITING

    Valencia, Spain

  • Hospital Universitario 12 de Octubre

    RECRUITING

    Madrid, Spain

  • Hospital Universitario Ramon y Cajal

    RECRUITING

    Madrid, Spain

  • Hospital Vall d'Hebron

    RECRUITING

    Barcelona, Spain

  • MDACC

    RECRUITING

    Houston, Texas, 77030, United States

  • Mayo Clinic Jacksonville

    RECRUITING

    Jacksonville, Florida, 32224, United States

  • Mayo Clinic Rochester

    RECRUITING

    Rochester, Minnesota, 55905, United States

  • Moffitt Cancer Center

    RECRUITING

    Tampa, Florida, 33612, United States

  • NEXT Dallas

    RECRUITING

    Irving, Texas, 75039, United States

  • NEXT Madrid

    RECRUITING

    Madrid, Spain

  • NEXT Virginia

    RECRUITING

    Fairfax, Virginia, 22031, United States

  • National Cancer Center

    RECRUITING

    Goyang, South Korea

  • START Barcelona Hospital HM Nou Delfos

    RECRUITING

    Barcelona, Spain

  • START Madrid CIOCC

    RECRUITING

    Madrid, Spain

  • Samsung Medical Center

    RECRUITING

    Seoul, South Korea

  • Sarah Cannon Research Institute

    RECRUITING

    Nashville, Tennessee, 37203, United States

  • Seoul National University Hospital

    RECRUITING

    Seoul, South Korea

  • Seoul National University; Bundang Hospital

    RECRUITING

    Seongnam, South Korea

  • Severance Hospital; Yonsei University Health System

    RECRUITING

    Seoul, South Korea

  • Start Madrid-FJD, Hospital Fundacion Jimenez Diaz

    RECRUITING

    Madrid, Spain

  • The Catholic University of Korea, St. Vincent's Hospital

    RECRUITING

    Goyang, South Korea

  • The Catholic University of Korea, St. Vincent's Hospital

    RECRUITING

    Suwon, South Korea

More trials for these conditions

Other studies related to the condition(s) this trial covers.