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

Part of paid clinical trials in Detroit, Michigan.

Sponsor
GlaxoSmithKline
Study ID
NCT07213609
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Neoplasms
  • Neoplasms, Colorectal

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • GSK5460025 — DRUG
    GSK5460025 will be administered

Study Details

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.

Key Dates

Start date
Oct 20, 2025
Status verified
Jun 2026
Primary completion
Sep 28, 2028
Completion
Oct 27, 2028

Study Design

Enrollment
47 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

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.

Primary Outcome Measure

Part 1: Number of participants with dose limiting toxicities (DLTs) per dose level [ Time Frame: Up to 28 days ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
GSK Investigational SiteDetroitMichigan48201
US GSK Clinical Trials Call Center
[email protected]
877-379-3718
EU GSK Clinical Trials Call Centre
[email protected]
+44 (0) 20 8990 4466
Wasif Saif (PRINCIPAL_INVESTIGATOR)
GSK Investigational SiteCantonOhio44718
US GSK Clinical Trials Call Center
[email protected]
877-379-3718
EU GSK Clinical Trials Call Centre
[email protected]
+44 (0) 20 8990 4466
Nashat Gabrail (PRINCIPAL_INVESTIGATOR)
GSK Investigational SiteNashvilleTennessee37203
US GSK Clinical Trials Call Center
[email protected]
877-379-3718
EU GSK Clinical Trials Call Centre
[email protected]
+44 (0) 20 8990 4466
Deepak Bhamidipati (PRINCIPAL_INVESTIGATOR)

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By research site
GSK Investigational Site· Detroit, MIGSK Investigational Site· Canton, OHGSK Investigational Site· Nashville, TN

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