A Study to Investigate the Safety and Preliminary Efficacy of GSK5460025 Alone or in Combination … (NCT07213609) | Clinical Trial Compass
RecruitingPhase 1/2
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
United States, Canada, Japan47 participantsStarted 2025-10-20
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Has a histologically diagnosed advanced (unresectable, metastatic or recurrent) solid tumor
* Has a known dMMR/MSI-H status as determined by a certified local laboratory at the time of Pre-screening or has an unknown Mismatch repair (MMR)/ Microsatellite Instability (MSI) status at the time of Pre-screening and MMR/MSI status will be determined by central reference laboratory
* Provides an archival or fresh (preferred) formalin fixed, paraffin embedded (FFPE) sample
* Intends to receive GSK5460025 as next treatment
* Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
* Is expected to have a minimum of 3 months life expectancy
* Has adequate organ function, as defined in the protocol
Part 1 inclusion criteria:
• Has histologically diagnosed advanced (unresectable, metastatic or recurrent) solid tumor and has exhausted all standard of care treatment options
Part 2 inclusion criteria:
* Has histologically diagnosed advanced (unresectable, metastatic or recurrent) Colorectal cancer (CRC) or Endometrial cancer (EC)
* Has received at least 1 but no more than 3 lines of systemic anticancer therapy for their advanced (unresectable, metastatic or recurrent) disease including at least one line of Immune checkpoint inhibitors (ICI) therapy
* Has measurable disease (i.e., at least 1 target lesion) during the Screening period per RECIST 1.1, as determined by the investigator
Exclusion Criteria:
* Has not recovered (i.e., to Grade ≤1 or …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this is a Phase 1/Phase 2 trial and the first part is mainly focused on finding a safe dose by tracking serious side effects and dose-limiting toxicities, what does that mean for my personal safety if I were to consider enrolling?
2The trial is testing GSK5460025 both alone and in combination with other anti-cancer agents — do you know which combination might be relevant to my specific tumor type, and how does that affect the risk profile compared to taking it on its own?
3Given that the Phase 1 portion is still figuring out the right dose, and dose adjustments due to side effects are being closely tracked, how would my treatment be monitored and adjusted if I experienced a serious adverse event?
4Would it make more sense for me to try a standard approved treatment first before considering an early-phase trial like this one, or is there a reason this study might be a better fit for where I am right now in my treatment journey?
5The Phase 2 part measures objective response rate — how confident are you in the early signals for my cancer type, and what is the realistic chance that this drug could work for me based on what's known so far?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Part 1: Number of participants with dose limiting toxicities (DLTs) per dose level
Timeframe: Up to 28 days
2
Part 1: Number of participants with treatment emergent serious adverse events (TESAEs) and treatment emergent adverse events (TEAEs) by severity per dose level
Timeframe: Up to approximately 33 months
3
Part 1: Number of participants with TESAEs and TEAEs by severity per dose level during DLT observation period
Timeframe: Up to 28 days
4
Part 1: Number of participants with dosage modifications due to TEAEs per dose level