GSK5533524 alone or with other treatments for adults with advanced solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This first-in-human, phase 1 study uses dose-escalation and expansion cohorts to find a safe and tolerable dose of GSK5533524 given alone or in combination. Participants are adults with advanced or metastatic solid tumors that have progressed after standard therapies. The study will collect safety data, measure how the body absorbs and clears the drug (pharmacokinetics), monitor for immune reactions, and look for early signs of tumor shrinkage or disease control. Results will guide the recommended dose and schedule for later trials.

Why it matters

Who can join: the full rules

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.

Where it's running

• 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

Study contacts

• Study coordinator: US GSK Clinical Trials Call Center
• Email: GSKClinicalSupportHD@gsk.com
• Phone: 877-379-3718

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.