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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT06431594
Registration number
NCT06431594
Ethics application status
Date submitted
21/05/2024
Date registered
28/05/2024
Titles & IDs
Public title
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Clinical Activity of GSK5733584 for Injection in Participants With Advanced Solid Tumors
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Scientific title
A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Clinical Activity of GSK5733584 for Injection in Subjects With Advanced Solid Tumors
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Secondary ID [1]
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2024-513860-25
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Secondary ID [2]
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222730
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Solid Tumors
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - GSK5733584
Experimental: Part 1: Dose Escalation -
Experimental: Part 2: Dose Expansion -
Treatment: Drugs: GSK5733584
GSK5733584 will be administered
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Part 1: Number of participants with dose limiting toxicity (DLT)
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Assessment method [1]
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Timepoint [1]
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Up to 21 days
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Primary outcome [2]
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Part 2: Objective Response Rate (ORR)
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Assessment method [2]
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ORR is defined as the proportion of participants with at least one confirmed Complete Response (CR) or Partial Response (PR) as defined by Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
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Timepoint [2]
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Up to approximately 28 months
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Secondary outcome [1]
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Part 1 and 2: Maximum observed concentration (Cmax) of GSK5733584
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Assessment method [1]
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Timepoint [1]
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Up to approximately 31 months
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Secondary outcome [2]
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Part 1 and 2: Time to reach Cmax (Tmax) of GSK5733584
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Assessment method [2]
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Timepoint [2]
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Up to approximately 31 months
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Secondary outcome [3]
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Part 1 and 2: Area under the concentration-time curve (AUC) of GSK5733584
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Assessment method [3]
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Timepoint [3]
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Up to approximately 31 months
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Secondary outcome [4]
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Part 1: Objective Response Rate (ORR)
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Assessment method [4]
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ORR is defined as the proportion of participants with at least one confirmed CR or PR as defined by RECIST 1.1
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Timepoint [4]
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Up to approximately 31 months
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Secondary outcome [5]
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Part 1 and 2: Disease control rate (DCR)
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Assessment method [5]
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DCR is defined as the percentage of subjects whose best overall response is Complete Response (CR), Partial Response (PR) or Stable Disease (SD)
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Timepoint [5]
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Up to approximately 31 months
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Secondary outcome [6]
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Part 1 and 2: Duration of response (DoR)
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Assessment method [6]
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DoR is defined as the time interval between the date of the first documented response (CR or PR) and the date of the first documented disease progression or death due to any cause
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Timepoint [6]
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Up to approximately 31 months
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Secondary outcome [7]
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Part 1 and 2: Progression-free survival (PFS)
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Assessment method [7]
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PFS is defined as the time interval between randomization (or from the first dose of the intervention) and the first documented disease progression or death due to any cause (whichever occurs first).
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Timepoint [7]
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Up to approximately 31 months
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Secondary outcome [8]
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Part 1 and 2:Number of participants with treatment-emergent Anti-drug antibodies (ADA)
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Assessment method [8]
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Timepoint [8]
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Up to approximately 31 months
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Secondary outcome [9]
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Part 1 and 2: Titers of ADA to GSK5733584
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Assessment method [9]
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Timepoint [9]
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Up to approximately 31 months
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Secondary outcome [10]
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Part 1 and 2: Number of participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
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Assessment method [10]
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Timepoint [10]
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Up to approximately 31 months
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Secondary outcome [11]
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Part 1 and 2: Number of participants with clinically significant changes in physical examination
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Assessment method [11]
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Timepoint [11]
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Baseline (Day -1) and up to approximately 31 months
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Secondary outcome [12]
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Part 1 and 2: Change from baseline in body temperature (degree Celsius)
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Assessment method [12]
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Timepoint [12]
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Baseline (Day -1) and up to approximately 31 months
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Secondary outcome [13]
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Part 1 and 2: Change from baseline in respiratory rate (breaths per minute)
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Assessment method [13]
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Timepoint [13]
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Baseline (Day -1) and up to approximately 31 months
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Secondary outcome [14]
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Part 1 and 2: Change from baseline in pulse rate (beats per minute)
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Assessment method [14]
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Timepoint [14]
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Baseline (Day -1) and up to approximately 31 months
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Secondary outcome [15]
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Part 1 and 2: Change from baseline in blood pressure [millimetres of mercury (mmHg)]
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Assessment method [15]
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Timepoint [15]
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Baseline (Day -1) and up to approximately 31 months
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Secondary outcome [16]
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Part 1 and 2: Change from baseline in weight [kilogram (kg)]
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Assessment method [16]
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Timepoint [16]
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Baseline (Day -1) and up to approximately 31 months
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Secondary outcome [17]
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Part 1 and 2: Change from baseline in white blood cell count (cells per microliter)
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Assessment method [17]
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Timepoint [17]
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Baseline (Day -1) and up to approximately 31 months
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Secondary outcome [18]
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Part 1 and 2: Change from baseline in hemoglobin (grams per deciliter)
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Assessment method [18]
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Timepoint [18]
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Baseline (Day -1) and up to approximately 31 months
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Secondary outcome [19]
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Part 1 and 2: Change from Baseline in Platelet count (cells per microliter)
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Assessment method [19]
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Timepoint [19]
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Baseline (Day -1) and up to approximately 31 months
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Secondary outcome [20]
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Part 1 and 2: Change from Baseline in Red Blood Cell Count (RBC) (million cells per microliter)
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Assessment method [20]
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Timepoint [20]
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Baseline (Day -1) and up to approximately 31 months
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Secondary outcome [21]
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Part 1 and 2: Change from Baseline in haematocrit (Proportion of red blood cells in blood)
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Assessment method [21]
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Timepoint [21]
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Baseline (Day -1) and up to approximately 31 months
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Secondary outcome [22]
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Part 1 and 2: Change from Baseline in Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils (giga cells per litre)
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Assessment method [22]
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Timepoint [22]
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Baseline (Day -1) and up to approximately 31 months
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Secondary outcome [23]
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Part 1 and 2: Change from Baseline in Glucose (fasting), Blood Urea Nitrogen (BUN), Creatinine, Sodium, Potassium, Calcium, Chloride, Magnesium Direct Bilirubin and Total Bilirubin (milligrams per decilitre)
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Assessment method [23]
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Timepoint [23]
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Baseline (Day -1) and up to approximately 31 months
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Secondary outcome [24]
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Part 1 and 2: Change from Baseline in AST/SGOT, ALT/ SGPT, ALP and CPK (International Units per litre)
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Assessment method [24]
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Aspartate Aminotransferase (AST) / Serum Glutamic-Oxaloacetic Transaminase (SGOT), Alanine Aminotransferase (ALT)/ Serum Glutamic-Pyruvic Transaminase and (SGPT), Alkaline phosphatase (ALP) and Creatinine Phosphokinase (CPK) will be analysed
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Timepoint [24]
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Baseline (Day -1) and up to approximately 31 months
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Secondary outcome [25]
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Part 1 and 2: Change from baseline in Total Protein and Albumin (Grams per deciliter)
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Assessment method [25]
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Timepoint [25]
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Baseline (Day -1) and up to approximately 31 months
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Secondary outcome [26]
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Part 1 and 2: Change from baseline in Amylase and Lipase (Units per liter)
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Assessment method [26]
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Timepoint [26]
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Baseline (Day -1) and up to approximately 31 months
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Secondary outcome [27]
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Part 1 and 2: Change from baseline in Creatinine clearance (milliliter per minute)
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Assessment method [27]
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Timepoint [27]
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Baseline (Day -1) and up to approximately 31 months
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Secondary outcome [28]
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Part 1 and 2: Change from baseline in Activated Partial Thromboplastin Time (aPTT), Prothrombin Time (PT) and Thrombin time (seconds)
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Assessment method [28]
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Timepoint [28]
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Baseline (Day -1) and up to approximately 31 months
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Secondary outcome [29]
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Part 1 and 2: Change from baseline in fibrinogen (milligrams per deciliter)
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Assessment method [29]
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Timepoint [29]
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Baseline (Day -1) and up to approximately 31 months
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Secondary outcome [30]
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Part 1 and 2: Change from baseline in liver panel parameter: International Normalized Ratio (INR)
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Assessment method [30]
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Timepoint [30]
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Baseline (Day -1) and up to approximately 31 months
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Secondary outcome [31]
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Part 1 and 2: Change from baseline in routine urine tests: Leukocyte esterase
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Assessment method [31]
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Leukocyte esterase measured as negative or positive
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Timepoint [31]
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Baseline (Day -1) and up to approximately 31 months
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Secondary outcome [32]
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Part 1 and 2: Change from baseline in routine urine tests: Occult blood (10^9 Cells Per Liter)
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Assessment method [32]
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Timepoint [32]
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Baseline (Day -1) and up to approximately 31 months
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Secondary outcome [33]
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Part 1 and 2: Change from baseline in routine urine tests: potential of hydrogen (pH) value
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Assessment method [33]
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Timepoint [33]
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Baseline (Day -1) and up to approximately 31 months
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Secondary outcome [34]
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Part 1 and 2: Change from baseline in routine urine tests: Protein and bilirubin (Grams Per Liter)
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Assessment method [34]
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Timepoint [34]
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Baseline (Day -1) and up to approximately 31 months
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Secondary outcome [35]
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Part 1 and 2: Change From Baseline in routine urine tests: Specific Gravity (Ratio)
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Assessment method [35]
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Timepoint [35]
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Baseline (Day -1) and up to approximately 31 months
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Secondary outcome [36]
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Part 1 and 2: Change from baseline in CA-125 tumor marker [units per milliliter (U/mL)]
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Assessment method [36]
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Timepoint [36]
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Baseline (Day -1) and up to approximately 31 months
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Secondary outcome [37]
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Part 1 and 2: Change from baseline in Electrocardiogram (ECG) readings [milliseconds (msec)]
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Assessment method [37]
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Timepoint [37]
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Baseline (Day -1) and up to approximately 31 months
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Secondary outcome [38]
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Part 1 and 2: Change from baseline in Left ventricular ejection fraction (LVEF) [Percentage]
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Assessment method [38]
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Timepoint [38]
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Baseline (Day -1) and up to approximately 31 months
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Secondary outcome [39]
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Part 1 and 2: Change from baseline in Eastern Cooperative Oncology Group Performance Scale (ECOG PS) score
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Assessment method [39]
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ECOG PS is used for measuring how the disease impacts a patient's daily living abilities. The grades for the scale range from 0 (fully active) to 5 (dead), with increasing severity.
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Timepoint [39]
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Baseline (Day -1) and up to approximately 31 months
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Secondary outcome [40]
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Part 2: Overall Survival (OS)
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Assessment method [40]
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OS is defined as the time interval between the date of randomization (or from the first dose of the investigational product) and the date of death due to any cause
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Timepoint [40]
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Up to approximately 31 months
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Eligibility
Key inclusion criteria
* Males or females aged 18 years or older (=18 years).
* Participants with pathologically confirmed advanced solid tumor (who have failed or are intolerant to standard of care).
* Participants have at least one target lesion as assessed per the RECIST 1.1
* Tumor tissue from a newly obtained biopsy or archival tumor tissue is required for retrospective detection of B7 homolog 4 (B7-H4) expression by Immunohistochemistry (IHC) in central laboratory and other biomarker analysis. Tissue from a newly obtained biopsy is preferred. If a newly obtained biopsy is not feasible, archival tumor tissue within 2 years prior to the first dose of study drug is acceptable.
* Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 to 2 and no deterioration within 2 weeks before the first dose.
* Have a life expectancy of at least 12 weeks.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Have received any of B7-H4-targeted therapies.
* Have received any of cytotoxic chemotherapy drugs, anti-tumor traditional Chinese medicines or other anti-tumor drugs within 28 days prior to the first dose of study drug; or need to continue these drugs during the study.
* Have 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 treatment.
* Presence of pleural/abdominal effusion/ascites requiring clinical intervention; presence of pericardial effusion
* Major surgery within 4 weeks prior to the first dose of study treatment.
* Evidence of brain metastasis unless asymptomatic.
* Has inadequate bone marrow reserve or hepatic/renal functions.
* Mean Fridericia-corrected QT interval (QTcF) > 470 millisecond (msec) on resting ECG.
* Evidence of current clinically significant arrhythmias or ECG abnormalities
* Risk factors of prolonged QTc or arrhythmia events,
* Left ventricular ejection fraction (LVEF) < 50%.
* Have severe, uncontrolled or active cardiovascular disorders, serious or poorly controlled hypertension, clinically significant bleeding symptoms or serious arteriovenous thromboembolic events
* Any evidence of current Interstitial lung disease (ILD) or pneumonitis or a prior history of ILD or pneumonitis requiring high-dose systemic glucocorticoids.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Other
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
21/06/2024
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
21/01/2027
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Actual
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Sample size
Target
240
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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GSK Investigational Site - Blacktown
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Recruitment hospital [2]
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GSK Investigational Site - Sydney
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Recruitment postcode(s) [1]
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2148 - Blacktown
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Recruitment postcode(s) [2]
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2109 - Sydney
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Florida
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Country [2]
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United States of America
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State/province [2]
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Massachusetts
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Country [3]
0
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United States of America
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State/province [3]
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Michigan
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Country [4]
0
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United States of America
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State/province [4]
0
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Texas
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Country [5]
0
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United States of America
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State/province [5]
0
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Utah
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Country [6]
0
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United States of America
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State/province [6]
0
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Washington
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Country [7]
0
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Canada
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State/province [7]
0
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Ontario
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Country [8]
0
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Canada
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State/province [8]
0
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Quebec
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Country [9]
0
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Finland
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State/province [9]
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Helsinki
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Country [10]
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Netherlands
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State/province [10]
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Amsterdam
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
GlaxoSmithKline
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The goal of this study is to assess the safety and tolerability of GSK5733584. The study will also see how the levels of GSK5733584 change over time at different dose amount.
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Trial website
https://clinicaltrials.gov/study/NCT06431594
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
0
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Email
0
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Contact person for public queries
Name
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US GSK Clinical Trials Call Center
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Address
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Country
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Phone
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877-379-3718
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/
Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF), Clinical study report (CSR)
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When will data be available (start and end dates)?
Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.
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Available to whom?
Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.
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Available for what types of analyses?
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How or where can data be obtained?
IPD available at link: https://www.gsk.com/en-gb/innovation/trials/data-transparency/
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT06431594