A First-in-Human (FIH) Study to Evaluate the Safety and Tolerability of VVD-130037 in Participants With Advanced Solid Tumors

Launched by VIVIDION THERAPEUTICS, INC. · Jul 12, 2023

Keywords

ClinConnect Summary

This clinical trial is testing a new treatment called VVD-130037 for people with advanced solid tumors, which are types of cancer that have spread and can’t be surgically removed. The main goal of the study is to see how safe this new treatment is, how it works in the body, and whether it might help patients whose cancer has not improved with standard therapies. If you or a loved one has a confirmed diagnosis of a metastatic or unresectable solid tumor and has tried all other standard treatments without success, you might be eligible to participate in this trial.

Participants should generally be between the ages of 65 and 74 and need to have good overall health, meaning they can perform daily activities with little difficulty. During the trial, participants will receive the treatment and will be monitored closely for any side effects or changes in their condition. It’s important to note that certain medical conditions, such as a history of seizures or specific heart problems, may prevent someone from joining the study. If you think this trial might be a good option, discussing it with a healthcare provider could be a helpful next step.

Gender

ALL

Eligibility 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.