ACTIVE_NOT_RECRUITING

A Study to Investigate the Safety, Pharmacokinetics, and Preliminary Effectiveness of GSK4418959 Alone or in Combination With Other Anti-cancer Agents in Participants With 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

Solid tumours are abnormal lumps of tissue that can occur in different parts of the body. The tumours involved in this study have specific genetic characteristics that can make them more aggressive and challenging to treat. The study will test whether GSK4418959 alone or in combination with a PD-1 inhibitor agent can decrease tumor size, is safe, well-tolerated, and how amounts of the study drug decrease in the body over time.

Official Title

A Phase 1/2 First-Time-in-Human, Open-label, Multicenter, Dose Escalation and Expansion Study of the Oral DNA Helicase Werner Inhibitor (WRNi) GSK4418959 Alone or in Combination With Other Anti-cancer Agents in Adult Participants With Mismatch Repair-deficient (dMMR) or Microsatellite Instability-High (MSI-H) Solid Tumors (SYLVER)

Quick Facts

Study Start:2024-12-13
Study Completion:2026-06-22
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06710847

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 Locations (Sites)

GSK Investigational Site
Los Angeles, California, 90095
United States
GSK Investigational Site
Denver, Colorado, 80218
United States
GSK Investigational Site
Detroit, Michigan, 48201
United States
GSK Investigational Site
New York, New York, 10016
United States
GSK Investigational Site
Philadelphia, Pennsylvania, 19104
United States
GSK Investigational Site
Philadelphia, Pennsylvania, 19107
United States

Collaborators and Investigators

Sponsor: GlaxoSmithKline

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 Date2024-12-13
Study Completion Date2026-06-22

Study Record Updates

Study Start Date2024-12-13
Study Completion Date2026-06-22

Terms related to this study

Keywords Provided by Researchers

  • GSK4418959
  • DNA Helicase Werner Inhibitor (WRNi)
  • PD-1 inhibitor
  • Solid tumors
  • Colon cancer
  • Rectal cancer
  • Colorectal cancer
  • Endometrial cancer
  • Mismatch repair deficient
  • dMMR
  • microsatellite instability high
  • MSI-H

Additional Relevant MeSH Terms

  • Neoplasms, Colorectal
  • Solid Tumor
  • Colon Cancer
  • Rectal Cancer
  • Endometrial Cancer