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Evaluating VVD-130037 for 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

PHASE1 · Vividion Therapeutics, Inc. · NCT05954312

This study is testing a new drug called VVD-130037 to see if it’s safe and effective for people with advanced solid tumors that haven't responded to other treatments.

Quick facts

PhasePHASE1
Study typeInterventional
Enrollment290 (estimated)
Ages18 Years and up
SexAll
SponsorVividion Therapeutics, Inc. (industry)
Drugs / interventionschemotherapy, immunotherapy, radiation, pembrolizumab
Locations26 sites (Jacksonville, Florida and 25 other locations)
Trial IDNCT05954312 on ClinicalTrials.gov

What this trial studies

This study is a first-in-human dose escalation and expansion trial assessing the safety and tolerability of VVD-130037 in patients with advanced solid tumors. Participants will receive VVD-130037 as a single agent, or in combination with docetaxel or paclitaxel. The study aims to determine the appropriate dosing and evaluate the drug's effects on measurable disease as defined by RECIST criteria. It targets patients who have progressed after standard therapies, focusing on specific tumor types such as squamous non-small cell lung cancer and head and neck squamous cell carcinoma.

Who should consider this trial

Good fit: Ideal candidates include individuals with advanced solid tumors who have progressed on prior therapies and meet specific inclusion criteria.

Not a fit: Patients with early-stage tumors or those who have not yet received standard-of-care treatments may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new treatment option for patients with advanced solid tumors who have limited alternatives.

How similar studies have performed: Other studies have shown promise with similar approaches targeting advanced solid tumors, but this specific drug and combination are novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
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)

Where this trial is running

Jacksonville, Florida and 25 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Advanced Solid Tumors, VVD-130037, First-in-Human, KEAP1, NRF2, Cancer, small molecule, squamous cell histology

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.