First Time in Human (FTIH) Study to Investigate the Safety and Preliminary Activity of GSK5533524 Alone or in Combination in Adult Participants With Advanced Solid Tumors

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
GlaxoSmithKline
Study ID
NCT07438782
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

  • Neoplasms

Eligibility Criteria

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

Interventions

  • GSK5533524 — DRUG
    GSK5533524 will be administered.

Study Details

The purpose of this study is to investigate a new drug GSK5533524 in adults with certain advanced cancers to find a safe dose and learn how well people tolerate it, so researchers can choose the best dose for the next stage of testing. The study will also check whether the drug can shrink tumours or slow cancer growth, monitor how the body absorbs and breaks down the drug, and look for any immune reactions that the body might develop against the treatment.

Key Dates

Start date
Mar 23, 2026
Status verified
May 2026
Primary completion
Feb 6, 2029
Completion
Feb 6, 2029

Study Design

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

Arms

  • Experimental: Part 1a: GSK5533524 Dose Escalation & Backfill
  • Experimental: Part 1b: GSK5533524 Dose Expansion

Primary Outcome Measure

Part 1a: Number of participants with dose limiting toxicities (DLTs) per dose level [ Time Frame: Up to 21 days ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
GSK Investigational SitePhiladelphiaPennsylvania19107
US GSK Clinical Trials Call Center
[email protected]
877-379-3718
EU GSK Clinical Trials Call Centre
[email protected]
+44 (0) 20 8990 4466
Ida Micaily (PRINCIPAL_INVESTIGATOR)
GSK Investigational SiteSan AntonioTexas78229
US GSK Clinical Trials Call Center
[email protected]
877-379-3718
EU GSK Clinical Trials Call Centre
[email protected]
+44 (0) 20 8990 4466
Drew Rasco (PRINCIPAL_INVESTIGATOR)

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