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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.

Phase 1RecruitingVividion Therapeutics, Inc.NCT05954312Data as of May 2026

Treatment: VVD-130037 · Docetaxel · Paclitaxel · PembrolizumabA 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.

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Extracted 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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