A Phase I, Open-Label,II-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

Study Identifier:
VVD-130850-01
CT.gov Identifier:
NCT06188208
EudraCT Identifier:
202351000000
EU Trial (CTIS) Number:
2023-508386-32-00
Study Contact Information:
(210) 593-5651 or [email protected]
Recruitment Complete

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Study 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.

To evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary anti-tumor activity of VVD-130850 in patients with advanced solid and hematologic tumors as a single-agent and in combination with immune checkpoint inhibition

Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
  • Solid Tumor
  • Hematological Cancer
    • Phase
    The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
    I
    Sex
    Female & Male
    Age
    18+ years
    Study Drug
  • Drug: Experimental: Dose Escalation
    • Read More
  • Drug: Experimental: Dose Expansion
    • Study Status
    Indicates the current recruitment status or the expanded access status
    Recruitment Complete

    Requirements information
    Inclusion criteria
    • Key
    • 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).

    Clinical Study Information for Healthcare Providers

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    Study Locations

    Location
    Investigator
    Status
    Condition(s) Treated at Site
    Location
    START Barcelona
    Barcelona, Spain, 08023
    Investigator
    Tatiana Hernandez Guerrero
    Status
    Recruitment Complete
    Condition(s) Treated at Site
    Solid Tumor
    Hematological Cancer