RECRUITING

A Study to Evaluate the Safety, Pharmacokinetics, and Anti-Tumor Activity of VVD-133214 as Monotherapy and in Combination With Pembrolizumab 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

This is a first-in-human, Phase I, open-label, multicenter, dose-escalation and dose expansion study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of VVD-133214 monotherapy, and in combination with pembrolizumab, in participants with microsatellite instability (MSI) and/or deficient mismatch repair (dMMR) advanced solid tumors. VVD-133214 is an oral drug that acts on a protein called Werner (WRN), which may promote the growth of cancers that are MSI and/or dMMR. By acting on WRN, VVD-133214 may be able to block the growth of these types of cancer.

Official Title

A Phase I, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Anti-Tumor Activity of VVD-133214 as Monotherapy and in Combination With Pembrolizumab in Participants With Advanced Solid Tumors Harboring Microsatellite Instability (MSI) and/or Deficient Mismatch Repair (dMMR)

Quick Facts

Study Start:2024-01-25
Study Completion:2027-05-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06004245

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. * Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
  2. * Have a microsatellite instability (MSI) and/or deficient mismatch repair (dMMR), histologically or cytologically documented advanced (unresectable and/or metastatic) solid tumor; for the combination with pembrolizumab only: Histologically confirmed locally advanced, or metastatic colorectal adenocarcinoma (CRC) with no prior systemic treatment for metastatic disease and not amenable to surgery
  3. * Have received and then progressed following, or are intolerant to, standard therapy in the advanced setting
  4. * Presence of measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
  5. * Life expectancy of at least (≥)12 weeks
  6. * Availability of formaldehyde-fixed paraffin-embedded (FFPE) archival tumor tissue for submission to Sponsor/central laboratory for retrospective central testing; for participants without archival tissue, a biopsy from either primary or metastatic tumor lesion, deemed medically feasible, must be taken
  7. * Adequate hematologic, end-organ, and cardiovascular function, as defined in the protocol
  1. * Inability or unwillingness to swallow pills
  2. * Malabsorption syndrome or other condition that would interfere with enteral absorption
  3. * Known hypersensitivity or intolerance to ingredients from the study drug formulation including patients with rare genetic disorders such as galactosaemia, glucose-galactose intolerance or congenital lactase deficiency
  4. * Known uncontrolled central nervous system (CNS) metastases (progressing or requiring anticonvulsants or corticosteroids for symptomatic control) and/or carcinomatous meningitis
  5. * Known active or uncontrolled bacterial, viral, fungal, mycobacterial (including but not limited to tuberculosis and atypical mycobacterial disease), parasitic, or other infection (excluding fungal infections of nail beds), or any major episode of infection requiring treatment with intravenous antibiotics or hospitalization within 2 weeks prior to the start of drug administration (related to the completion of the course of antibiotics, except if for tumor fever) or 6 months for any intracranial abscess
  6. * Has a positive test at screening for hepatitis B virus, hepatitis C virus, or for human immodeficiency virus (HIV), per local diagnostic standard and in accordance with local laws and regulations
  7. * Uncontrolled diabetes or symptomatic hyperglycemia (i.e., well controlled defined as a screening hemoglobin A1c \<8% and no urinary ketoacidosis)
  8. * Significant cardiovascular/cerebrovascular disease within 6 months prior to Day 1 of study drug administration
  9. * Alcohol or drug dependence or abuse
  10. * Patients with known Werner (WRN) syndrome
  11. * Prior treatment with any WRN helicase inhibitor
  12. * Treatment with moderate or strong CYP3A4 inducers within 14 days prior to initiation of study treatment
  13. * Treatment with moderate or strong CYP3A4 or P-glycoprotein inhibitors within 14 days prior to initiation of study treatment
  14. * Pregnancy, breastfeeding, or intention of becoming pregnant during the study
  15. * Active or history of autoimmune disease or immune deficiency with some exceptions
  16. * History of interstitial lung disease or pneumonitis
  17. * Treatment with systemic immunosuppressive medication (such as corticosteroids) within 2 weeks prior to initiation of study treatment with some exceptions
  18. * Treatment with organ transplant/graft tissue

Contacts and Locations

Study Contact

Vividion Clinical Trial Call Center
CONTACT
1+ 858-345-9752 (U.S. Only)
clinicaltrials@vividion.com

Principal Investigator

Clinical Trials
STUDY_DIRECTOR
Vividion Therapeutics

Study Locations (Sites)

City of Hope Cancer Center
Duarte, California, 91010
United States
City of Hope - Santa Clarita
Valencia, California, 91355-9512
United States
Norton Cancer Institute - MDC
Louisville, Kentucky, 40202
United States
Duke University
Durham, North Carolina, 27705
United States
Oklahoma University Health Sciences Center
Oklahoma City, Oklahoma, 73170
United States
SCRI Oncology Partners
Nashville, Tennessee, 37203
United States
MD Anderson Cancer Center
Houston, Texas, 77030
United States

Collaborators and Investigators

Sponsor: Vividion Therapeutics, Inc.

  • Clinical Trials, STUDY_DIRECTOR, Vividion Therapeutics

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 Date2024-01-25
Study Completion Date2027-05-31

Study Record Updates

Study Start Date2024-01-25
Study Completion Date2027-05-31

Terms related to this study

Keywords Provided by Researchers

  • Deficient mismatch repair
  • dMMR
  • Microsatellite instability
  • MSI

Additional Relevant MeSH Terms

  • Advanced Solid Tumors