Recruiting
Phase 1
Phase 2

GSK5460025

Sponsor:

GlaxoSmithKline

Code:

NCT07213609

Conditions

Neoplasms, Colorectal

Neoplasms

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

GSK5460025

Study Details

Brief 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.

Conditions

Neoplasms, Colorectal

Neoplasms

Study ID

NCT07213609

Start date

Oct 20, 2025

Status verified date

Jul, 2026

Completion date

Oct 27, 2028

Anticipated

Primary completion date

Sep 28, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

47 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Part 1: Dose escalation of GSK5460025 monotherapy

Participants will receive GSK5460025 as monotherapy.

experimental: Part 2: Dose expansion of GSK5460025 monotherapy

Participants will receive GSK5460025 as monotherapy.

Interventions

GSK5460025

GSK5460025 will be administered

Primary outcome measure

  • Part 1: Number of participants with dose limiting toxicities (DLTs) per dose level [ Time Frame: 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 [ Time Frame: Up to approximately 33 months ]
  • Part 1: Number of participants with TESAEs and TEAEs by severity per dose level during DLT observation period [ Time Frame: Up to 28 days ]
  • Part 1: Number of participants with dosage modifications due to TEAEs per dose level [ Time Frame: Up to approximately 33 months ]
  • Part 2: Objective Response Rate (ORR) [ Time Frame: Up to approximately 33 months ]

Central Contacts and Locations

Central contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Center

+44 (0) 20 89904466GSKClinicalSupportHD@gsk.com

Locations

GSK Investigational Site

Recruiting

Aurora, Colorado, United States, 80045

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

Jill Alldredge

GSK Investigational Site

Recruiting

Detroit, Michigan, United States, 48201

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

Wasif Saif

GSK Investigational Site

Recruiting

Canton, Ohio, United States, 44718

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

Nashat Gabrail

GSK Investigational Site

Recruiting

Nashville, Tennessee, United States, 37203

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

Deepak Bhamidipati

GSK Investigational Site

Recruiting

Hamilton, Ontario, Canada, L8V 5C2

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

Courtney Coschi

GSK Investigational Site

Recruiting

Toronto, Ontario, Canada, M5G 2M9

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

Abdulazeez Salawu

GSK Investigational Site

Recruiting

Montreal, Quebec, Canada, H4A 3J1

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

Xing Zeng

More Information

Sponsor

GlaxoSmithKline

Last update posted

Jul 21, 2026

Last verified

Jul, 2026

Keywords

  • GSK5460025
  • Solid tumors
  • Colon cancer
  • Rectal cancer
  • Colorectal cancer
  • Endometrial cancer
  • Mismatch repair deficient
  • dMMR
  • microsatellite instability high
  • MSI-H

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by GlaxoSmithKline on 2026-07-21.