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NCT07438782
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
Conditions: Neoplasms
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE1
Enrollment: 97
Sponsor: GlaxoSmithKline
Location: GSK Investigational Site Philadelphia Pennsylvania
Summary
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.
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 to standard therapy, for which no standard treatment is available, or who is intolerant to established standard of care therapies.
* 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.
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 \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.
Source: ClinicalTrials.gov (NCT07438782). StuddyBuddy aggregates publicly available trial information.