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

Description

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.

Conditions

Advanced Solid Tumors, Advanced Hematologic Tumors

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Advanced Solid Tumors
Intervention / Treatment

-

Contacts and Locations

Sarasota

Florida Cancer Specialists, Sarasota, Florida, United States, 34232

Nashville

Sarah Cannon Research Institute, Nashville, Tennessee, United States, 37203

Austin

NEXT Austin, Austin, Texas, United States, 78758

Houston

MDACC, Houston, Texas, United States, 77030

Irving

NEXT Dallas, Irving, Texas, United States, 75039

San Antonio

NEXT San Antonio, San Antonio, Texas, United States, 78299

Salt Lake City

University of Utah Huntsman Cancer Institute, Salt Lake City, Utah, United States, 84112

Fairfax

NEXT Virginia, Fairfax, Virginia, United States, 22031

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • 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).

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Vividion Therapeutics, Inc.,

Study Record Dates

2027-12