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
Trial overview
Part 1a: Number of participants with dose limiting toxicities (DLTs) per dose level
Timeframe: Up to 21 days
Part 1a: Number of participants with adverse events (AEs), serious adverse events (SAEs), by Severity per dose level
Timeframe: Up to approximately 34 months
Part 1b: Objective Response Rate (ORR)
Timeframe: Up to approximately 27 months
Part 1a & 1b: Number of participants with adverse events (AEs), serious adverse events (SAEs), Treatment-Emergent AEs (TEAEs) by severity, Adverse Events of Special Interest (AESIs), and AEs leading to dose modifications and treatment discontinuation
Timeframe: Up to approximately 34 months
Part 1a: Objective Response Rate (ORR)
Timeframe: Up to approximately 27 months
Part 1a & 1b: Duration of Response (DoR)
Timeframe: Up to approximately 27 months
Part 1a & 1b: Pharmacokinetic (PK) Concentrations of GSK5533524 and its components
Timeframe: Up to approximately 27 months
Part 1a & 1b: Number of participants with Anti-drug antibodies (ADA) against GSK5533524
Timeframe: Up to approximately 27 months
Part 1a & 1b: Titers of ADA against GSK5533524
Timeframe: Up to approximately 27 months
- 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 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 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.
Is at least 18 years of age or the legal age of consent
- 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 that required steroids, 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 intervention.
- Has received immunosuppressive agents or required long-term glucocorticoid therapy within 30 days prior to first dose of study treatment.
- Has corrected QT interval by Fridericia formula (QTcF) >450 msec or QTcF >480 msec for participants with bundle branch block.
- Has a left ventricular ejection fraction (LVEF) < 50%.
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.
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
No study documents available.
Results overview
Study Results yet to be posted
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.