Status:
ACTIVE_NOT_RECRUITING
A First-in-Human (FIH) Study to Evaluate the Safety and Tolerability of VVD-130850 in Participants With Advanced Solid and Hematologic Tumors
Lead Sponsor:
Vividion Therapeutics, Inc.
Conditions:
Advanced Solid Tumors
Advanced Hematologic Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
A FIH study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of VVD-130850, as single agent and in combination with checkpoint inhibition, in participants with advanced soli...
Eligibility Criteria
Inclusion
- Key
- Histologically or cytologically confirmed metastatic or unresectable solid tumor or advanced non-Hodgkin's lymphoma (NHL).
- Eastern Cooperative Oncology Group (ECOG) performance status ≤1.
- Adequate organ and bone marrow function as defined in the protocol.
- 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.
- Measurable disease by RECIST version 1.1 as assessed by the Investigator.
- Key
Exclusion
- Have a diagnosis of immunodeficiency or are receiving systematic steroid therapy or any other form of immunosuppressive therapy.
- Prior allogeneic transplantation.
- History of cardiac diseases as defined in detail in the protocol.
- Clinically significant infection or any eye infection.
- Active central nervous system (CNS) malignancies (previously treated CNS malignancies are not exclusionary).
- 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).
Key Trial Info
Start Date :
January 5 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2027
Estimated Enrollment :
125 Patients enrolled
Trial Details
Trial ID
NCT06188208
Start Date
January 5 2024
End Date
January 1 2027
Last Update
October 16 2025
Active Locations (20)
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1
California Research Institute
Los Angeles, California, United States, 90027
2
Florida Cancer Specialists
Sarasota, Florida, United States, 34232
3
Sarah Cannon Research Institute
Nashville, Tennessee, United States, 37203
4
NEXT Austin
Austin, Texas, United States, 78758