Clinical Trial 22540

• Overview

  Study Title:

  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

  Summary:

  A FIH study to evaluate the safety, pharmacokinetics, pharmacodynamics, and preliminary efficacy of VVD-130037 in participants with advanced solid tumors.

  Objective:

  Primary To determine the maximum tolerated dose (MTD) or the maximum administered dose (MAD) of VVD-130037. Secondary To determine the recommended dose(s) for expansion (RDE[s]) in subsequent development. To characterize the PK of VVD-130037. To investigate the effect of VVD-130037 on cardiac repolarization (QT/QTc).

• Treatments

  Therapies:

  Chemotherapy (NOS); Immunotherapy; KEAP1 activator; Therapy (NOS)

  Medications:

  Pembrolizumab (Keytruda); Taxol (paclitaxel); Taxotere (docetaxel); VVD-130037 (); docetaxel (); paclitaxel ()

• Inclusion Criteria

  Inclusion Criteria:
  • 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 of 1 or less.
  • Adequate organ and marrow function as defined in the protocol.
  • Other criteria apply

• Exclusion Criteria

  Exclusion Criteria:
  • Participant is known to have a mutation that has no expectation of benefit from VVD-130037. Current such mutations include the following: KEAP1 nonsense mutation (any position) KEAP1 frameshift mutation (any position)
  • Any unresolved toxicity Grade or more 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.
  • Uncontrolled arterial hypertension despite optimal medical management.
  • History of inflammatory bowel disease or any malabsorption syndrome or any conditions that would interfere with enteral absorption and/or may interfere with the conduct of the study.
  • Known human immunodeficiency virus (HIV), except as noted in protocol.
  • Active hepatitis B infection (positive for hepatitis B surface antigen and hepatitis B virus DNA).
  • Active hepatitis C infection (positive anti-hepatitis C virus antibody and quantitative hepatitis C virus ribonucleic acid results greater than the lower limits of detection of the assay).
  • Participant has known allergies or hypersensitivity to the study drug or study drug excipients
  • Other criteria apply

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