A Study to Investigate the Safety and Preliminary Efficacy of GSK5460025 Alone or in Combination With Other Anti-cancer Agents in Participants With Solid Tumors
Condition(s) studied
Investigational drug(s) / intervention(s)
GSK5460025: GSK5460025 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 GSK5460025 alone or in combination (potential combinations may be included in future amendments to the protocol) with other anti-cancer agents can decrease tumor size, is safe, well-tolerated, and how the drug is processed in the body over time.
Eligibility
Primary outcome measure(s)
- Part 1: Number of participants with dose limiting toxicities (DLTs) per dose level — Up to 28 days
- Part 1: Number of participants with treatment emergent serious adverse events (TESAEs) and treatment emergent adverse events (TEAEs) by severity per dose level — Up to approximately 33 months
- Part 1: Number of participants with TESAEs and TEAEs by severity per dose level during DLT observation period — Up to 28 days
- Part 1: Number of participants with dosage modifications due to TEAEs per dose level — Up to approximately 33 months
- Part 2: Objective Response Rate (ORR) — Up to approximately 33 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 (27)
| Facility | City | Region | Status |
|---|---|---|---|
| GSK Investigational Site | Aurora | Colorado | Recruiting |
| GSK Investigational Site | Detroit | Michigan | Recruiting |
| GSK Investigational Site | Canton | Ohio | Recruiting |
| GSK Investigational Site | Nashville | Tennessee | Recruiting |
| GSK Investigational Site | Hamilton | Ontario | Recruiting |
| GSK Investigational Site | Toronto | Ontario | Recruiting |
| GSK Investigational Site | Montreal | Quebec | Recruiting |
| GSK Investigational Site | København Ø | Capital Region | Recruiting |
| GSK Investigational Site | Lyon | France | Recruiting |
| GSK Investigational Site | Saint-Herblain | France | Recruiting |
| GSK Investigational Site | Villejuif | France | Recruiting |
| GSK Investigational Site | Milan | Italy | Recruiting |
| GSK Investigational Site | Milan | Italy | Recruiting |
| GSK Investigational Site | Chiba | Japan | Recruiting |
| GSK Investigational Site | Osaka | Japan | Recruiting |
| GSK Investigational Site | Tokyo | Japan | Recruiting |
| GSK Investigational Site | Tokyo | Japan | Recruiting |
| GSK Investigational Site | Amsterdam | Netherlands | Recruiting |
| GSK Investigational Site | Utrecht | Netherlands | Recruiting |
| GSK Investigational Site | Barcelona | Spain | Recruiting |
| GSK Investigational Site | Madrid | Spain | Recruiting |
| GSK Investigational Site | Madrid | Spain | Recruiting |
| GSK Investigational Site | Madrid | Spain | Recruiting |
| GSK Investigational Site | Madrid | Spain | Recruiting |
| GSK Investigational Site | Lund | Sweden | Recruiting |
| GSK Investigational Site | Stockholm | Sweden | Recruiting |
| GSK Investigational Site | Uppsala | Sweden | Recruiting |
More GlaxoSmithKline trials in Spain
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 NCT07213609 on ClinicalTrials.gov ↗ ← All trials in Spain