Last updated: 02/23/2026 18:10:27

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

GSK study ID
300163
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Trial status
Will be recruiting
Will be recruiting
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: A Phase 1, open-label, multicenter study of GSK5533524 alone or in combination with other anti-cancer agents, in adult participants with selected advanced solid tumors
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Sequential Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:

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

Timeframe: Up to 21 days

Part 1a: Number of participants with adverse events (AEs), serious adverse events (SAEs), by Severity per dose level

Timeframe: Up to approximately 34 months

Part 1b: Objective Response Rate (ORR)

Timeframe: Up to approximately 27 months

Secondary outcomes:

Part 1a & 1b: Number of participants with adverse events (AEs), serious adverse events (SAEs), Treatment-Emergent AEs (TEAEs) by severity, Adverse Events of Special Interest (AESIs), and AEs leading to dose modifications and treatment discontinuation

Timeframe: Up to approximately 34 months

Part 1a: Objective Response Rate (ORR)

Timeframe: Up to approximately 27 months

Part 1a & 1b: Duration of Response (DoR)

Timeframe: Up to approximately 27 months

Part 1a & 1b: Pharmacokinetic (PK) Concentrations of GSK5533524 and its components

Timeframe: Up to approximately 27 months

Part 1a & 1b: Number of participants with Anti-drug antibodies (ADA) against GSK5533524

Timeframe: Up to approximately 27 months

Part 1a & 1b: Titers of ADA against GSK5533524

Timeframe: Up to approximately 27 months

Interventions:
  • Drug: GSK5533524
  • Enrollment:
    97
    Primary completion date:
    2029-13-02
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Neoplasms
    Product
    Not applicable
    Collaborators
    Not applicable
    Study date(s)
    March 2026 to February 2029
    Type
    Interventional
    Phase
    1

    Participation criteria

    Sex
    Female & Male
    Age
    18+ years
    Accepts healthy volunteers
    No
    • Is at least 18 years of age or the legal age of consent
    • Has histologically or cytologically confirmed advanced/metastatic solid tumor that is refractory to standard therapy, for which no standard treatment is available, or who is intolerant to established standard of care therapies.
    • Has a history of clinically significant or uncontrolled cardiac disease, acute myocardial infarction, congestive heart failure or clinically significant arrhythmia not controlled by Standard of care therapy.
    • Presence of pleural/abdominal effusion/ascites requiring clinical intervention; presence of pericardial effusion.

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    No study documents available.

    Results overview

    Study Results yet to be posted

    Recruitment status
    Will be recruiting
    Actual primary completion date
    Not applicable
    Actual study completion date
    Not applicable

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

    Additional information
    Not applicable
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