Actively Recruiting
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
Led by GlaxoSmithKline · Updated on 2026-04-06
97
Participants Needed
2
Research Sites
151 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- At least 18 years of age or legal age of consent
- Histologically or cytologically confirmed advanced/metastatic solid tumor refractory to standard therapy or intolerant to standard care
- Documented disease progression based on radiologic imaging during or after most recent treatment
- At least one target lesion per RECIST 1.1 (for Part 1a backfill and Part 1b participants)
- Eastern Cooperative Oncology Group performance status of 0 or 1 with no deterioration in the 2 weeks before enrollment
- Adequate organ function
You will not qualify if you...
- History of clinically significant or uncontrolled cardiac disease, acute myocardial infarction, congestive heart failure, or uncontrolled arrhythmia
- Presence of pleural or abdominal effusion/ascites requiring intervention or pericardial effusion
- Untreated or progressing brain or central nervous system metastases
- Grade 2 or higher corneal epithelial condition
- Any active renal condition
- History of autoimmune disease requiring systemic treatment within 2 years prior to screening
- Ongoing adverse reactions from prior therapy not recovered to Grade 1 or baseline
- History or current interstitial lung disease or pneumonitis
- Lung-specific clinically significant illness
- Forced expiratory volume in 1 second (FEV1) less than 50% predicted
- Chronic enteritis, inflammatory bowel disease, or significant gastrointestinal bleeding, obstruction, perforation, or fistula
- Known hypersensitivity to GSK5533524 or its components
- History of severe allergies, severe infusion reactions, or idiosyncrasy to recombinant humanized proteins
- Receipt of cytotoxic chemotherapy or other anti-tumor drugs within 28 days prior to first dose
- Receipt of locoregional radiation therapy within 2 weeks prior to first dose; more than 30% bone marrow irradiation or wide-field radiation within 4 weeks prior
- Use of immunosuppressive agents or long-term glucocorticoids within 30 days prior to first dose
- Use of medications known to prolong QT/QTc interval or cause torsades de pointes
- Corrected QT interval by Fridericia formula greater than 470 msec or greater than 480 msec with bundle branch block
- Left ventricular ejection fraction less than 50%
- Risk factors for prolonged QT/QTc or torsades de pointes such as heart failure, refractory hypokalemia, congenital long QT syndrome, family history of long QT syndrome, or unexplained sudden death of a close relative under 40 years old
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
GSK Investigational Site
Montreal, Quebec, Canada, H2X 0A9
Actively Recruiting
2
GSK Investigational Site
Tokyo, Japan, 135-8550
Actively Recruiting
Research Team
U
US GSK Clinical Trials Call Center
CONTACT
E
EU GSK Clinical Trials Call Center
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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