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
Condition(s) studied
Investigational drug(s) / intervention(s)
GSK4418959: GSK4418959 will be administered.
PD-1 inhibitor: PD-1 inhibitor will be administered.
Study summary
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.
Eligibility
Primary outcome measure(s)
- Part 1: Number of participants with dose limiting toxicities (DLTs) during DLT observation period — Up to 21 days
- Part 3: Number of participants with dose limiting toxicities (DLTs) during DLT observation period — Up to 21 days
- Part 1: Number of participants with treatment emergent adverse events (TEAEs) during DLT observation period — Up to 21 days
- Part 3: Number of participants with treatment emergent adverse events (TEAEs) during DLT observation period — Up to 21 days
- Part 1: Number of participants with dosage interruptions, dose reductions, and drug discontinuations for TEAEs during DLT observation period — Up to 21 days
- Part 3: Number of participants with dosage interruptions, dose reductions, and drug discontinuations for TEAEs during DLT observation period — Up to 21 days
- Part 2: Objective Response Rate (ORR) — Up to approximately 26 months
ORR is defined as percentage of participants with confirmed complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1) by investigator assessment.
Trial sites (22)
| Facility | City | Region | Status |
|---|---|---|---|
| GSK Investigational Site | Los Angeles | California | |
| GSK Investigational Site | Denver | Colorado | |
| GSK Investigational Site | Detroit | Michigan | |
| GSK Investigational Site | New York | New York | |
| GSK Investigational Site | Philadelphia | Pennsylvania | |
| GSK Investigational Site | Philadelphia | Pennsylvania | |
| GSK Investigational Site | Melbourne | Victoria | |
| GSK Investigational Site | Brussels | Belgium | |
| GSK Investigational Site | Ghent | Belgium | |
| GSK Investigational Site | Leuven | Belgium | |
| GSK Investigational Site | Chiba | Japan | |
| GSK Investigational Site | Shizuoka | Japan | |
| GSK Investigational Site | Tokyo | Japan | |
| GSK Investigational Site | Tokyo | Japan | |
| GSK Investigational Site | Amsterdam | Netherlands | |
| GSK Investigational Site | Daegu | South Korea | |
| GSK Investigational Site | Gyeonggi-do | South Korea | |
| GSK Investigational Site | Seoul | South Korea | |
| GSK Investigational Site | Barcelona | Spain | |
| GSK Investigational Site | Barcelona | Spain | |
| GSK Investigational Site | Madrid | Spain | |
| GSK Investigational Site | Málaga | Spain |
More GlaxoSmithKline trials in Belgium
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06710847 on ClinicalTrials.gov ↗ ← All trials in Belgium