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Recruiting NCT07213609

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

Phase I / Phase II Interventional Neoplasms, Colorectal Neoplasms

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: GSK5460025.
Who it may be relevant to
Registry conditions: Neoplasms, Colorectal, Neoplasms. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Canada, Denmark, Japan, Netherlands +2
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Drug GSK5460025
    GSK5460025 will be administered

Primary outcome measures

  • 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]
Secondary outcome measures (11)
  • Part 1: Plasma concentrations for GSK5460025 [Time frame: Up to approximately 36 months]
  • Part 1: Area under the concentration-time curve (AUC) for GSK5460025 [Time frame: Up to approximately 36 months]
  • Part 1: Maximum concentration (Cmax) for GSK5460025 [Time frame: Up to approximately 36 months]
  • Part 1: Time to maximum concentration (Tmax) for GSK5460025 [Time frame: Up to approximately 36 months]
  • Part 1: Number of participants with clinically important changes in laboratory parameters, Electrocardiogram (ECGs), and vital signs per dose level [Time frame: Up to approximately 36 months]
  • Part 2: Number of participants with TESAEs and TEAEs by severity [Time frame: Up to approximately 36 months]
  • Part 2: Number of participants with TEAEs leading to dosage modifications [Time frame: Up to approximately 36 months]
  • Part 2: Number of participants with clinically important changes in laboratory parameters, ECGs, and vital signs [Time frame: Up to approximately 36 months]
  • Part 2: Progression-free Survival (PFS) [Time frame: Up to approximately 36 months]
  • Part 2: Duration of Response (DoR) [Time frame: Up to approximately 36 months]
  • Part 2: Plasma concentration of GSK5460025 [Time frame: Up to approximately 36 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Sequential
Masking
Open label
Primary purpose
Treatment

Study locations

Spain · 5 centers
  • GSK Investigational Site — Barcelona
  • GSK Investigational Site — Madrid
  • GSK Investigational Site — Madrid
  • GSK Investigational Site — Madrid
  • GSK Investigational Site — Madrid
United States · 4 centers
  • GSK Investigational Site — Aurora
  • GSK Investigational Site — Detroit
  • GSK Investigational Site — Canton
  • GSK Investigational Site — Nashville
Japan · 4 centers
  • GSK Investigational Site — Chiba
  • GSK Investigational Site — Osaka
  • GSK Investigational Site — Tokyo
  • GSK Investigational Site — Tokyo
Canada · 3 centers
  • GSK Investigational Site — Hamilton
  • GSK Investigational Site — Toronto
  • GSK Investigational Site — Montreal
Sweden · 3 centers
  • GSK Investigational Site — Lund
  • GSK Investigational Site — Stockholm
  • GSK Investigational Site — Uppsala
Netherlands · 2 centers
  • GSK Investigational Site — Amsterdam
  • GSK Investigational Site — Utrecht
Denmark · 1 center
  • GSK Investigational Site — Copenhagen

Identifiers

NCT: NCT07213609 · 224035 · 2025-522318-21

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗