Actively Recruiting
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
Led by GlaxoSmithKline · Updated on 2026-03-23
47
Participants Needed
9
Research Sites
157 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Has a histologically diagnosed advanced (unresectable, metastatic or recurrent) solid tumor
- Has a known dMMR/MSI-H status or will have this status determined by a central laboratory
- Provides an archival or fresh formalin fixed, paraffin embedded (FFPE) sample
- Plans to receive GSK5460025 as next treatment
- Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- Has an expected life expectancy of at least 3 months
- Has adequate organ function as defined in the protocol
- Part 1: Has advanced solid tumor and exhausted all standard treatment options
- Part 2: Has advanced colorectal or endometrial cancer
- Part 2: Has received 1 to 3 lines of systemic anticancer therapy including immune checkpoint inhibitors
- Part 2: Has measurable disease during screening per RECIST 1.1 criteria
You will not qualify if you...
- Has not recovered to Grade 1 or baseline from prior anticancer therapy side effects
- Has previously been treated with a Werner (WRN) inhibitor or Nucleotide Excision Repair Targeting agent
- Cannot swallow or retain oral study treatment
- Has untreated or progressing brain or central nervous system metastases
- Has another cancer that progressed or needed treatment within 2 years, except certain skin or in situ carcinomas that were fully removed
- Has gastrointestinal problems that affect drug absorption
- Has cirrhosis or unstable liver or biliary disease
- Has known allergy to the study treatments or their ingredients
AI-Screening
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Trial Site Locations
Total: 9 locations
1
GSK Investigational Site
Canton, Ohio, United States, 44718
Actively Recruiting
2
GSK Investigational Site
Nashville, Tennessee, United States, 37203
Actively Recruiting
3
GSK Investigational Site
Hamilton, Ontario, Canada, L8V 5C2
Actively Recruiting
4
GSK Investigational Site
Toronto, Ontario, Canada, M5G 2M9
Actively Recruiting
5
GSK Investigational Site
Montreal, Quebec, Canada, H4A 3J1
Actively Recruiting
6
GSK Investigational Site
Chiba, Japan, 277-8577
Actively Recruiting
7
GSK Investigational Site
Osaka, Japan, 573-1191
Actively Recruiting
8
GSK Investigational Site
Tokyo, Japan, 104-0045
Actively Recruiting
9
GSK Investigational Site
Tokyo, Japan, 135-8550
Actively Recruiting
Research Team
U
US GSK Clinical Trials Call Center
CONTACT
E
EU GSK Clinical Trials Call Center
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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