- 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 — Recruiting • Phase I • Oncology • NCT07438782.
- Drug Being Tested: GSK5533524, a novel investigational agent, is being evaluated in a first-in-human study as monotherapy and in combination regimens to establish safety, tolerability, and optimal dosing in adults with advanced solid tumors.
- Patient Eligibility Overview: The trial enrolls adult participants with advanced solid tumors who have limited or exhausted standard treatment options, with eligibility criteria typically including adequate organ function and performance status to tolerate investigational therapy.
- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
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.
- : * 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.
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.