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Clinical Trials in the USA / NCT07213609
Recruiting Phase 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

NCT07213609 · tracked via the Priya Life Science USA tracker
Sponsor
GlaxoSmithKline
Phase
Phase 1/2
Started
2025-10-20
Last updated
2026-09-16

Condition(s) studied

Neoplasms, ColorectalNeoplasms

Investigational drug(s) / intervention(s)

GSK5460025

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

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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 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. * Is unable to swallow and retain orally administered study treatment * Has untreated or progressed metastases in brain or CNS * 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

Primary outcome measure(s)

Trial sites (27)

FacilityCityRegionStatus
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 the USA

Other trials for the same condition

Official registry record

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 the USA