OncoMatch/Clinical Trials/NCT05954312
A First-in-Human (FIH) Study to Evaluate the Safety and Tolerability of VVD-130037 in Participants With Advanced Solid Tumors
Is NCT05954312 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including VVD-130037 and Docetaxel for advanced solid tumors.
Treatment: VVD-130037 · Docetaxel · Paclitaxel · Pembrolizumab — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Tumor Agnostic
Biomarker criteria
Excluded: KEAP1 nonsense mutation
KEAP1 nonsense mutation (any position)
Excluded: KEAP1 frameshift mutation
KEAP1 frameshift mutation (any position)
Allowed: NFE2L2 mutation
with or without nuclear factor erythroid 2-related factor 2 (NRF2 [NFE2L2]) and/or cullin 3 (CUL3) mutations
Allowed: CUL3 mutation
with or without nuclear factor erythroid 2-related factor 2 (NRF2 [NFE2L2]) and/or cullin 3 (CUL3) mutations
Allowed: EGFR activating mutation
Participants with a known driver mutation, including activating epidermal growth factor receptor mutations ... should have progressed after appropriate targeted treatment
Allowed: ALK rearrangement
Participants with a known driver mutation, including ... anaplastic lymphoma kinase rearrangements, should have progressed after appropriate targeted treatment
Allowed: HER2 (ERBB2) overexpression
Participants with known human epidermal growth factor receptor 2 overexpression should have progressed after appropriate targeted treatment
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: standard-of-care therapies — metastatic
Have progressed on or after all prior standard-of-care therapies for metastatic disease
Must have received: platinum-based chemotherapy — metastatic
must be refractory to or have progressed on or after a platinum-based doublet regimen
Must have received: immune checkpoint inhibitor — metastatic
must be refractory to or have progressed on or after ... an immune checkpoint inhibitor
Must have received: anti-EGFR therapy — metastatic
must have received prior treatment with ... an anti-epidermal growth factor receptor agent
Cannot have received: anti-epileptic medications
Current or prior treatment with anti-epileptic medications for the treatment or prophylaxis of seizures
Lab requirements
Blood counts
Adequate organ and marrow function as defined in the protocol
Kidney function
Adequate organ and marrow function as defined in the protocol
Liver function
Adequate organ and marrow function as defined in the protocol
Cardiac function
Risk factors for abnormal heart rhythm/QT prolongation as defined in the protocol; history of cardiac diseases (NYHA >II, unstable angina, new onset angina within past 6 months, MI within past 6 months, clinically significant arrhythmias within past 6 months)
Adequate organ and marrow function as defined in the protocol. Risk factors for abnormal heart rhythm/QT prolongation as defined in the protocol. History of the following cardiac diseases: i) congestive heart failure (NYHA >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.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Mayo Clinic Jacksonville · Jacksonville, Florida
- Florida Cancer Specialists · Sarasota, Florida
- Moffitt Cancer Center · Tampa, Florida
- Mayo Clinic Rochester · Rochester, Minnesota
- Sarah Cannon Research Institute · Nashville, Tennessee
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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