A First-in-Human (FIH) Study to Evaluate the Safety and Tolerability of VVD-130037 in Participants With Advanced Solid Tumors
Trial Status: active
A FIH dose escalation and dose expansion study to evaluate VVD-130037 in participants with advanced solid tumors as a single agent, in combination with docetaxel, and in combination with paclitaxel.
Inclusion 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.
Additional locations may be listed on ClinicalTrials.gov for NCT05954312.
Locations matching your search criteria
United States
Florida
Jacksonville
Mayo Clinic in Florida
Status: Active
Name Not AvailableTampa
Moffitt Cancer Center
Status: Active
Name Not AvailableMinnesota
Rochester
Mayo Clinic in Rochester
Status: Active
Name Not AvailableTexas
Houston
M D Anderson Cancer Center
Status: Active
Name Not AvailableTrial PhasePhase I
Trial Typetreatment
Lead OrganizationVividion Therapeutics, Inc.
- Primary IDVVD-130037-001
- Secondary IDsNCI-2024-00249, 2023-506199-28-00
- ClinicalTrials.gov IDNCT05954312