The EDC is live today — see what ships now
All studies
NCT07438782From ClinicalTrials.govRecruiting

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

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

  • Neoplasms

At a glance

Phase
Phase 1
Study type
Interventional
Sponsor
GlaxoSmithKline
Enrolment target
97
Started
23 March 2026
Main results due
6 February 2029
Study sites
20
Registry updated
25 September 2026

Can you take part?

  • Aged 18 years and over.
  • Open to any sex.
  • You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full eligibility criteria
Inclusion Criteria:

* 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 or intolerant to standard therapy, has exhausted all treatment options and is not considered a candidate for definitive radiotherapy.
* Has documented disease progression based on radiologic imaging, during or after most recent line of treatment.
* Has at least one target lesion per RECIST 1.1.
* Has an Eastern Cooperative Oncology Group performance status of 0 or 1 and no deterioration in the 2 weeks before enrollment.
* Has adequate organ function.
* Has a life expectancy of at least 3 months.

Exclusion Criteria:

* 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.
* Has untreated brain or central nervous system metastases or metastases that have progressed
* Has a Grade ≥2 corneal epithelial condition.
* Has any active renal condition
* Has a history of autoimmune disease that has required systemic treatments in the 2 years prior to screening.
* Has ongoing adverse reaction(s) from prior therapy that has(have) not recovered to ≤Grade 1 or to the baseline status preceding prior therapy.
* Has a history of (non-infectious) interstitial lung disease (ILD)/pneumonitis, or current ILD/pneumonitis.
* Has a lung-specific intercurrent clinically significant illness
* Has FEV1 \<50% predicted
* Has chronic enteritis or inflammatory bowel disease or any history of clinically significant bleeding of gastrointestinal tract or clinically significant obstruction and/or perforation and/or fistulae of GI tract.
* Has a known hypersensitivity to any component of GSK5533524 or its excipients.
* Has history of severe allergies, or severe infusion related reactions, or idiosyncrasy to recombinant humanized proteins.
* Has received any cytotoxic chemotherapy drugs, or other anti-tumor drugs within 28 days prior to the first dose of study drug.
* Has received radiotherapy to the lungs, or to adjacent organs, within 6 months prior to the first dose of study intervention; locoregional radiation therapy within 2 weeks prior to the first dose of study drug; more than 30% of bone marrow irradiation or wide-field radiation therapy within 4 weeks prior to the first dose of study intervention.
* Has received immunosuppressive agents or required long-term glucocorticoid therapy within 30 days prior to first dose of study treatment.
* The use of concomitant medications known to prolong the QT/QTc interval or potentially cause torsades de pointes.
* Has corrected QT interval by Fridericia formula (QTcF) \>470 msec or QTcF \>480 msec for participants with bundle branch block.
* Has a left ventricular ejection fraction (LVEF) \< 50%.
* Has risk factors for prolonged QT/QTc or TdP, such as heart failure, refractory hypokalemia, congenital long QT syndrome, family history of long QT syndrome, or unexplained sudden death of any direct relative under 40 years old.

What this study is about

In the sponsor’s own words, from the registry.

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.

Study sites(20)

  • GSK Investigational Site

    Philadelphia, Pennsylvania, United States

    Recruiting

  • GSK Investigational Site

    San Antonio, Texas, United States

    Recruiting

  • GSK Investigational Site

    Toronto, Ontario, Canada

    Recruiting

  • GSK Investigational Site

    Montreal, Quebec, Canada

    Recruiting

  • GSK Investigational Site

    Montreal, Quebec, Canada

    Recruiting

  • GSK Investigational Site

    København Ø, Capital Region, Denmark

    Recruiting

  • GSK Investigational Site

    Helsinki, Finland

    Recruiting

  • GSK Investigational Site

    Bordeaux, France

    Recruiting

  • GSK Investigational Site

    Villejuif, France

    Recruiting

  • GSK Investigational Site

    Saitama, Japan

    Recruiting

  • GSK Investigational Site

    Shizuoka, Japan

    Recruiting

  • GSK Investigational Site

    Tokyo, Japan

    Recruiting

  • GSK Investigational Site

    Tokyo, Japan

    Recruiting

  • GSK Investigational Site

    Barcelona, Spain

    Recruiting

  • GSK Investigational Site

    Madrid, Spain

    Recruiting

  • GSK Investigational Site

    Madrid, Spain

    Recruiting

  • GSK Investigational Site

    Madrid, Spain

    Recruiting

  • GSK Investigational Site

    Madrid, Spain

    Recruiting

  • GSK Investigational Site

    Cambridge, United Kingdom

    Recruiting

  • GSK Investigational Site

    Edinburgh, United Kingdom

    Recruiting

Showing 20 of 20 sites. 20 of the 20 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT07438782. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

Not the right study?

Answer three questions and see the studies recruiting near you, in plain language.

Find a study for me
First Time in Human (FTIH) Study to Investigate the Safety and Preliminary Activity of GSK5533524 Alone or in | Trialion