Health TrialsbyHealthPanel

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

ConditionsNeoplasms, ColorectalNeoplasms
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorGlaxoSmithKline

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Sequential

Treatments tested in this trial

  • GSK5460025

    Drug

    GSK5460025 will be administered

Treatment groups

47 Participants
are divided into 2 treatment groups
Group A: Part 1: Dose escalation of GSK5460025 monotherapyExperimental treatment 1 intervention
Group B: Part 2: Dose expansion of GSK5460025 monotherapyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Part 1: Number of participants with dose limiting toxicities (DLTs) per dose level

Time frame
Up to 28 days
2

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
3

Part 1: Number of participants with TESAEs and TEAEs by severity per dose level during DLT observation period

Time frame
Up to 28 days
4

Part 1: Number of participants with dosage modifications due to TEAEs per dose level

Time frame
Up to approximately 33 months

Secondary outcomes

1

Part 1: Plasma concentrations for GSK5460025

Time frame
Up to approximately 36 months
2

Part 1: Area under the concentration-time curve (AUC) for GSK5460025

Time frame
Up to approximately 36 months
3

Part 1: Maximum concentration (Cmax) for GSK5460025

Time frame
Up to approximately 36 months
4

Part 1: Time to maximum concentration (Tmax) for GSK5460025

Time frame
Up to approximately 36 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

GlaxoSmithKline

Lead sponsor

Source ClinicalTrials.gov
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