VVD-130850-01
A Phase 1, Open-Label, 2-Part, Multicenter, First-in-Human Dose Escalation and Dose Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Anti-Tumor Activity of the STAT3 Inhibitor VVD-130850 as Single Agent and in Combination With Checkpoint Inhibition in Participants With Advanced Solid and Hematologic Tumors
Trial 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 solid and hematologic tumors.
Receptor status / problem studied:
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:
|— a) Serine/threonine kinase 11/ liver kinase B1 (STK11/LKB1) mutated non-small cell lung cancer (NSCLC) as assessed by historical (local) test.
|— b) 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.
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:
|— a) Known hypersensitivity or contraindication to pembrolizumab or any of its components.
|— b) 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).
Trial Title
VVD-130850-01
Diagnosis
Advanced solid tumours
Type of trial
Pharmaceutical
Type of treatement
Medical Oncology
Phase
I