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.
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