RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2024-01-05
Study Completion:2027-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06188208

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Histologically or cytologically confirmed metastatic or unresectable solid tumor or advanced non-Hodgkin's lymphoma (NHL).
  2. 2. Eastern Cooperative Oncology Group (ECOG) performance status ≤1.
  3. 3. Adequate organ and bone marrow function as defined in the protocol.
  4. 4. For Combination Therapy Expansion:
  5. * Serine/threonine kinase 11/ liver kinase B1 (STK11/LKB1) mutated non-small cell lung cancer (NSCLC) as assessed by historical (local) test.
  6. * 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.
  7. 5. Measurable disease by RECIST version 1.1 as assessed by the Investigator.
  1. 1. Have a diagnosis of immunodeficiency or are receiving systematic steroid therapy or any other form of immunosuppressive therapy.
  2. 2. Prior allogeneic transplantation.
  3. 3. History of cardiac diseases as defined in detail in the protocol.
  4. 4. Clinically significant infection or any eye infection.
  5. 5. Active central nervous system (CNS) malignancies (previously treated CNS malignancies are not exclusionary).
  6. 6. Combination Therapy Expansion:
  7. * Known hypersensitivity or contraindication to pembrolizumab or any of its components.
  8. * 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).

Contacts and Locations

Study Contact

Vividion Clinical Trial Call Center
CONTACT
(858) 345-9752
clinicaltrials@vividion.com

Study Locations (Sites)

Florida Cancer Specialists
Sarasota, Florida, 34232
United States
Sarah Cannon Research Institute
Nashville, Tennessee, 37203
United States
NEXT Austin
Austin, Texas, 78758
United States
MDACC
Houston, Texas, 77030
United States
NEXT Dallas
Irving, Texas, 75039
United States
NEXT San Antonio
San Antonio, Texas, 78299
United States
University of Utah Huntsman Cancer Institute
Salt Lake City, Utah, 84112
United States
NEXT Virginia
Fairfax, Virginia, 22031
United States

Collaborators and Investigators

Sponsor: Vividion Therapeutics, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-01-05
Study Completion Date2027-12

Study Record Updates

Study Start Date2024-01-05
Study Completion Date2027-12

Terms related to this study

Keywords Provided by Researchers

  • VVD-130850
  • Phase I
  • First in Human
  • Cancer
  • small molecule
  • STAT3
  • NSCLC
  • STK11
  • LKB1
  • immunosuppression
  • Checkpoint inhibitor
  • PD-1

Additional Relevant MeSH Terms

  • Advanced Solid Tumors
  • Advanced Hematologic Tumors