A First-in-Human (FIH) Study to Evaluate the Safety and Tolerability of VVD-130850 in Participants With Advanced Solid and Hematologic Tumors

Launched by VIVIDION THERAPEUTICS, INC. · Dec 31, 2023

Keywords

ClinConnect Summary

This clinical trial is testing a new treatment called VVD-130850 for patients with advanced solid tumors (like some types of cancer) and advanced blood cancers (called hematologic tumors). The main goal of the study is to see if this treatment is safe and if patients can tolerate it well. The trial will also look at how the body processes the drug and how it affects the tumors when given alone or alongside another treatment that helps the immune system fight cancer.

To participate, patients need to have certain types of cancer that have spread or cannot be removed by surgery. They should be generally well and able to carry out daily activities, as determined by a simple performance scale. The trial is open to adults aged 65-74. Participants will undergo regular check-ups to monitor their health and the effects of the treatment. It's important to note that certain health conditions or previous treatments may exclude someone from joining, so potential participants should discuss their medical history with their doctor to see if they qualify.

Gender

ALL

Eligibility criteria

• Key Inclusion Criteria:
• • 1. Histologically or cytologically confirmed metastatic or unresectable solid tumor or advanced non-Hodgkin's lymphoma (NHL).
• • 2. Eastern Cooperative Oncology Group (ECOG) performance status ≤1.
• • 3. Adequate organ and bone marrow function as defined in the protocol.
• 4. For Combination Therapy Expansion:
• • Serine/threonine kinase 11/ liver kinase B1 (STK11/LKB1) mutated non-small cell lung cancer (NSCLC) as assessed by historical (local) test.
• • Must be refractory to or have progressed on or after a platinum-based doublet regimen and an immune checkpoint inhibitor (CPI). These therapies could have been given in the same line of therapy or different lines of therapy.
• • 5. Measurable disease by RECIST version 1.1 as assessed by the Investigator.
• Key Exclusion Criteria:
• • 1. Have a diagnosis of immunodeficiency or are receiving systematic steroid therapy or any other form of immunosuppressive therapy.
• • 2. Prior allogeneic transplantation.
• • 3. History of cardiac diseases as defined in detail in the protocol.
• • 4. Clinically significant infection or any eye infection.
• • 5. Active central nervous system (CNS) malignancies (previously treated CNS malignancies are not exclusionary).
• 6. Combination Therapy Expansion:
• • Known hypersensitivity or contraindication to pembrolizumab or any of its components.
• • Any prior toxicity (Grade 3 or 4) related to immunotherapy leading to treatment discontinuation with the exception of the history of immunotherapy-related endocrinopathy controlled with ongoing medical management (e.g., hypothyroidism, adrenal insufficiency, diabetes).