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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

StatusRecruiting
PhasePhase 1
Started
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Record History

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  1. Trial sites expanded: 16 → 20 locations
    • Eligibility criteria expanded, about 46 words
    • Secondary endpoints: details revised at 5 of 6 entries
  2. Trial sites expanded: 8 → 16 locationsv4
  3. Trial sites expanded: 2 → 8 locations
    • Primary and study completion dates: Feb 13, 2029 to Feb 6, 2029
    v3
  4. Recruitment opened
    • Study sites: 0 to 2
    • Start date changed from estimate of Mar 31, 2026 to Mar 23, 2026
    • Eligibility criteria expanded, about 50 words
    v2
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
GlaxoSmithKline
246 trials monitored
See 20 trials at risk
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.
Trial Details
NCT Number NCT07438782
Lead Sponsor GlaxoSmithKline
Conditions
(from sponsor)		 Neoplasms
Related terms Neoplasms
Enrollment 97 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov