Tests GSK5460025 alone or combined with other drugs in solid tumors
Tests the pill GSK5460025 in adults with certain solid tumors that have specific genetic traits.
Plain-language title generated from the registry record
Registry title: 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
Key facts
- Where
- Amsterdam and Utrecht, NetherlandsSee the 2 sites
- Phase
- Phase 1/2
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with advanced solid tumors that have a mismatch repair-deficient (dMMR) or microsatellite instability-high (MSI-H) status. They must plan to take GSK5460025 as their next treatment.
- Age
- 18 years and older
- Sex
- All sexes can join.
- Disease stage
- Advanced solid tumor that cannot be removed by surgery, has spread, or has come back. Part 1: all standard treatment options have been used up. Part 2: colorectal or endometrial cancer with at least 1 measurable tumor.
- Earlier treatment
- Part 2: 1 to 3 earlier lines of cancer drug treatment for the advanced disease, including at least 1 line of immune checkpoint inhibitor treatment. Earlier treatment with a Werner (WRN) inhibitor or a Nucleotide Excision Repair Targeting (NERT) agent is not allowed.
- Biomarker or test result
- Known dMMR/MSI-H tumor status, or unknown status that will be tested by a central laboratory. A tumor tissue sample is needed.
Main reasons for not taking part
- Side effects from earlier cancer treatment have not recovered to Grade 1 or baseline
- Cannot swallow and keep down the study medicine
- Untreated or growing cancer in the brain or central nervous system
- Another cancer that grew or needed treatment in the last 2 years
- Stomach or bowel disease that could change how the drug is absorbed, or cirrhosis or unstable liver or bile duct disease
Read by machine on 9 November 2026.
Where in Netherlands
- AmsterdamHospital not named in the registryTaking people
- UtrechtHospital not named in the registryTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- GlaxoSmithKline
- Trial code
- NCT07213609
- Record updated
- 16 September 2026
- Original 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 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.Read full original descriptionShow less
A Phase 1/2 Open-label, Multicenter Study of Oral GSK5460025 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
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.
Inclusion: 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: Has not recovered (i.e., to Grade ≤1 or to baseline) from prior anticancer therapy-induced Adverse Events (AEs); Has received prior treatment with a Werner (WRN) inhibitor or Nucleotide Excision Repair Targeting (NERT) agent; Has a known additional malignancy that progressed or required active treatment within the last 2 years because reoccurrence of another malignancy would confound interpretation by RECIST 1.1 criteria. Exceptions include basal or squamous cell carcinomas of the skin or in situ carcinomas [e.g., breast, cervix, bladder] that have been resected with no evidence of metastatic disease; Has any impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of study drugs; Has cirrhosis or current unstable liver or biliary disease; Has known hypersensitivity to any of the study interventions or any of their excipients; Is unable to swallow and retain orally administered study treatment; Has untreated or progressed metastases in brain or CNS.