RECRUITING

A First-in-Human (FIH) Study to Evaluate the Safety and Tolerability of VVD-130037 in Participants With Advanced Solid 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 dose escalation and dose expansion study to evaluate VVD-130037 in participants with advanced solid tumors as a single agent, and in combination with docetaxel, paclitaxel, or pembrolizumab.

Official Title

A Phase 1, Open-label, Multicenter, First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Anti-tumor Activity of VVD-130037, a Kelch-like ECH Associated Protein 1 (KEAP1) Activator, in Participants With Advanced Solid Tumors

Quick Facts

Study Start:2023-07-28
Study Completion:2031-02-28
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05954312

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. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

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

Study Locations (Sites)

Mayo Clinic Jacksonville
Jacksonville, Florida, 32224
United States
Florida Cancer Specialists
Sarasota, Florida, 34232
United States
Moffitt Cancer Center
Tampa, Florida, 33612
United States
Mayo Clinic Rochester
Rochester, Minnesota, 55905
United States
Sarah Cannon Research Institute
Nashville, Tennessee, 37203
United States
MDACC
Houston, Texas, 77030
United States
NEXT Dallas
Irving, Texas, 75039
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 Date2023-07-28
Study Completion Date2031-02-28

Study Record Updates

Study Start Date2023-07-28
Study Completion Date2031-02-28

Terms related to this study

Keywords Provided by Researchers

  • VVD-130037
  • First-in-Human
  • KEAP1
  • NRF2
  • Cancer
  • small molecule
  • squamous cell histology
  • esophageal adenocarcinoma

Additional Relevant MeSH Terms

  • Advanced Solid Tumors