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Tests treatment safety and results for Neoplasms
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
ClinicalTrials.gov ID: NCT07438782
What this study is testing
What is GSK5533524?
GSK5533524 is an investigational medicine, being studied as a potential treatment for neoplasms.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- 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 (participants in Part 1a backfill and Part 1b).
- Has an Eastern Cooperative Oncology Group performance status of 0 or 1 and no deterioration in the 2 weeks before enrollment.
You likely can't join if
- Has a history of clinically significant or uncontrolled cardiac disease, acute myocardial infarction, congestive heart failure or clinically...
- 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.
See the full eligibility 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 to standard therapy, for which no standard treatment is available, or who is intolerant to established standard of care...
- 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 (participants in Part 1a backfill and Part 1b).
- 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 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 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Philadelphia, Pennsylvania, United States
- San Antonio, Texas, United States
- Toronto, Ontario, Canada
- Montreal, Quebec, Canada
- Helsinki, Finland
- Saitama, Japan
- Shizuoka, Japan
- Tokyo, Japan
- Barcelona, Spain
- Madrid, Spain
- Cambridge, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Philadelphia, Pennsylvania, United States; San Antonio, Texas, United States; Toronto, Ontario, Canada; Montreal, Quebec, Canada; Helsinki, Finland; Saitama, Japan and 5 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.