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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
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
Secondary ID [1] 0 0
2024-513860-25
Secondary ID [2] 0 0
222730
Universal Trial Number (UTN)
Trial acronym
BEHOLD-1
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Solid Tumors 0 0
Neoplasms 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - GSK5733584

Experimental: Part 1: Dose Escalation - Participants with advanced solid tumors who are refractory or intolerant to established standard therapies

Experimental: Part 2: Dose Expansion - Participants with platinum-resistant ovarian cancer (PROC) and endometrial cancer (EC)


Treatment: Drugs: GSK5733584
GSK5733584 will be administered
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Part 1: Number of participants with dose limiting toxicity (DLT)
Timepoint [1] 0 0
Up to 21 days
Primary outcome [2] 0 0
Part 2: Confirmed Objective Response Rate (ORR)
Timepoint [2] 0 0
Up to approximately 28 months
Secondary outcome [1] 0 0
Part 1 and 2: Maximum observed concentration (Cmax) of GSK5733584 and its components: conjugated antibody, total antibody, and small molecule toxin
Timepoint [1] 0 0
Up to approximately 31 months
Secondary outcome [2] 0 0
Part 1 and 2: Time to reach Cmax (Tmax) of GSK5733584 and its components: conjugated antibody, total antibody, and small molecule toxin
Timepoint [2] 0 0
Up to approximately 31 months
Secondary outcome [3] 0 0
Part 1 and 2: Area under the concentration-time curve (AUC) of GSK5733584 and its components: conjugated antibody, total antibody, and small molecule toxin
Timepoint [3] 0 0
Up to approximately 31 months
Secondary outcome [4] 0 0
Part 1: Confirmed Objective Response Rate (ORR)
Timepoint [4] 0 0
Up to approximately 31 months
Secondary outcome [5] 0 0
Part 1 and 2: Duration of response (DoR)
Timepoint [5] 0 0
Up to approximately 31 months
Secondary outcome [6] 0 0
Part 1 and 2: Progression-free survival (PFS)
Timepoint [6] 0 0
Up to approximately 31 months
Secondary outcome [7] 0 0
Part 1 and 2:Number of participants with treatment-emergent Anti-drug antibodies (ADA)/ Neutralizing antibody (NAb)
Timepoint [7] 0 0
Up to approximately 31 months
Secondary outcome [8] 0 0
Part 1 and 2: Titers of ADA to GSK5733584
Timepoint [8] 0 0
Up to approximately 31 months
Secondary outcome [9] 0 0
Part 1 and 2: Number of participants with Adverse Events (AEs), and Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs)
Timepoint [9] 0 0
Up to approximately 31 months
Secondary outcome [10] 0 0
Part 1 and 2: Change from baseline in body temperature (degree Celsius)
Timepoint [10] 0 0
Baseline (Day -1) and up to approximately 31 months
Secondary outcome [11] 0 0
Part 1 and 2: Change from baseline in respiratory rate (breaths per minute)
Timepoint [11] 0 0
Baseline (Day -1) and up to approximately 31 months
Secondary outcome [12] 0 0
Part 1 and 2: Change from baseline in pulse rate (beats per minute)
Timepoint [12] 0 0
Baseline (Day -1) and up to approximately 31 months
Secondary outcome [13] 0 0
Part 1 and 2: Change from baseline in blood pressure [millimetres of mercury (mmHg)]
Timepoint [13] 0 0
Baseline (Day -1) and up to approximately 31 months
Secondary outcome [14] 0 0
Part 1 and 2: Change from baseline in weight [kilogram (kg)]
Timepoint [14] 0 0
Baseline (Day -1) and up to approximately 31 months
Secondary outcome [15] 0 0
Part 1 and 2: Change from baseline in white blood cell count (cells per microliter)
Timepoint [15] 0 0
Baseline (Day -1) and up to approximately 31 months
Secondary outcome [16] 0 0
Part 1 and 2: Change from baseline in hemoglobin (grams per deciliter)
Timepoint [16] 0 0
Baseline (Day -1) and up to approximately 31 months
Secondary outcome [17] 0 0
Part 1 and 2: Change from Baseline in Platelet count (cells per microliter)
Timepoint [17] 0 0
Baseline (Day -1) and up to approximately 31 months
Secondary outcome [18] 0 0
Part 1 and 2: Change from Baseline in Red Blood Cell Count (RBC) (million cells per microliter)
Timepoint [18] 0 0
Baseline (Day -1) and up to approximately 31 months
Secondary outcome [19] 0 0
Part 1 and 2: Change from Baseline in haematocrit (Proportion of red blood cells in blood)
Timepoint [19] 0 0
Baseline (Day -1) and up to approximately 31 months
Secondary outcome [20] 0 0
Part 1 and 2: Change from Baseline in Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils (giga cells per litre)
Timepoint [20] 0 0
Baseline (Day -1) and up to approximately 31 months
Secondary outcome [21] 0 0
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)
Timepoint [21] 0 0
Baseline (Day -1) and up to approximately 31 months
Secondary outcome [22] 0 0
Part 1 and 2: Change from Baseline in AST/SGOT, ALT/ SGPT, ALP and CPK (International Units per litre)
Timepoint [22] 0 0
Baseline (Day -1) and up to approximately 31 months
Secondary outcome [23] 0 0
Part 1 and 2: Change from baseline in Total Protein and Albumin (Grams per deciliter)
Timepoint [23] 0 0
Baseline (Day -1) and up to approximately 31 months
Secondary outcome [24] 0 0
Part 1 and 2: Change from baseline in Amylase and Lipase (Units per liter)
Timepoint [24] 0 0
Baseline (Day -1) and up to approximately 31 months
Secondary outcome [25] 0 0
Part 1 and 2: Change from baseline in Creatinine clearance (milliliter per minute)
Timepoint [25] 0 0
Baseline (Day -1) and up to approximately 31 months
Secondary outcome [26] 0 0
Part 1 and 2: Change from baseline in Prothrombin Time (PT), Partial thromboplastin time (PTT) or Activated Partial Thromboplastin Time (aPTT) (seconds)
Timepoint [26] 0 0
Baseline (Day -1) and up to approximately 31 months
Secondary outcome [27] 0 0
Part 1 and 2: Change from baseline in liver panel parameter: International Normalized Ratio (INR)
Timepoint [27] 0 0
Baseline (Day -1) and up to approximately 31 months
Secondary outcome [28] 0 0
Part 1 and 2: Change from baseline in routine urine tests: Leukocyte esterase
Timepoint [28] 0 0
Baseline (Day -1) and up to approximately 31 months
Secondary outcome [29] 0 0
Part 1 and 2: Change from baseline in routine urine tests: Occult blood (10^9 Cells Per Liter)
Timepoint [29] 0 0
Baseline (Day -1) and up to approximately 31 months
Secondary outcome [30] 0 0
Part 1 and 2: Change from baseline in routine urine tests: potential of hydrogen (pH) value
Timepoint [30] 0 0
Baseline (Day -1) and up to approximately 31 months
Secondary outcome [31] 0 0
Part 1 and 2: Change from baseline in routine urine tests: Protein and bilirubin (Grams Per Liter)
Timepoint [31] 0 0
Baseline (Day -1) and up to approximately 31 months
Secondary outcome [32] 0 0
Part 1 and 2: Change From Baseline in routine urine tests: Specific Gravity (Ratio)
Timepoint [32] 0 0
Baseline (Day -1) and up to approximately 31 months
Secondary outcome [33] 0 0
Part 1 and 2: Change from baseline in CA-125 tumor marker among ovarian cancer participants [units per milliliter (U/mL)]
Timepoint [33] 0 0
Baseline (Day -1) and up to approximately 31 months
Secondary outcome [34] 0 0
Part 1 and 2: Change from baseline in Thyroid stimulating hormone (TSH) [microunits per milliliter (µU/mL)]
Timepoint [34] 0 0
Baseline (Day -1) and up to approximately 31 months
Secondary outcome [35] 0 0
Part 1 and 2: Change from baseline in free thyroxine (T4) [nanograms per deciliter (ng/dL)]
Timepoint [35] 0 0
Baseline (Day -1) and up to approximately 31 months
Secondary outcome [36] 0 0
Part 1 and 2: Change from baseline in Electrocardiogram (ECG) readings [milliseconds (msec)]
Timepoint [36] 0 0
Baseline (Day -1) and up to approximately 31 months
Secondary outcome [37] 0 0
Part 1 and 2: Change from baseline in Left ventricular ejection fraction (LVEF) [Percentage]
Timepoint [37] 0 0
Baseline (Day -1) and up to approximately 31 months
Secondary outcome [38] 0 0
Part 1 and 2: Change from baseline in Eastern Cooperative Oncology Group Performance Scale (ECOG PS) score
Timepoint [38] 0 0
Baseline (Day -1) and up to approximately 31 months
Secondary outcome [39] 0 0
Part 2: Overall Survival (OS)
Timepoint [39] 0 0
Up to approximately 31 months

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).
* PROC cohort

1. Histologically documented, advanced (metastatic and/or unresectable) high-grade serous/endometrioid ovarian, primary peritoneal, or fallopian tube cancer.
2. Must have received or are intolerant to 1 but no more than 3 lines of prior systemic therapy.
3. Platinum-resistant disease, defined as progression or relapse within 6 months after the completion of platinum-based therapy.
4. Must have had prior bevacizumab if the participant was considered a candidate for this regimen and the regimen is locally available.
5. Participants with known Folate receptor-a (FR-a) expressing tumors must have received mirvetuximab soravtasine if the participants was considered a candidate for this regimen and the regimen is locally available.
6. Participants with known Breast cancer susceptibility gene (BRCA) mutated tumors should have received a Poly adenosine diphosphate-ribose polymerase (PARP) inhibitor if the participant was considered a candidate for this regimen and the regimen is locally available.
7. Maintenance therapy will be considered part of the preceding line of therapy (ie, not counted independently).
* Endometrial cancer cohort

1. Histologically documented, advanced (metastatic and/or unresectable) or recurrent endometrial cancer.
2. Must have received or are intolerant to 1 but no more than 2 lines of prior systemic therapy.
3. Must have had prior platinum and PD(L)-1 inhibitor (in same regimen or in separate regimens), if considered a candidate for this regimen and the regimen is locally available.
4. Maintenance therapy will be considered part of the preceding line of therapy (ie, not counted independently
5. All epithelial histologies are permitted including carcinosarcoma.
* 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.
* Have received prior therapy with topoisomerase inhibitors or topoisomerase inhibitor Antibody-drug conjugate (ADCs)
* PROC

1. Primary platinum refractory not permitted.
2. Non-epithelial carcinoma, clear-cell, mucinous, germ-cell, low-grade serous, or low-grade endometrioid carcinoma not permitted.
* Endometrial cancer a. Mesenchymal tumors of the uterus (uterine sarcomas) not permitted.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
2/07/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/07/2027
Actual
Sample size
Target
240
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
GSK Investigational Site - Blacktown
Recruitment hospital [2] 0 0
GSK Investigational Site - Macquarie University
Recruitment postcode(s) [1] 0 0
2148 - Blacktown
Recruitment postcode(s) [2] 0 0
2109 - Macquarie University
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Florida
Country [2] 0 0
United States of America
State/province [2] 0 0
Massachusetts
Country [3] 0 0
United States of America
State/province [3] 0 0
Michigan
Country [4] 0 0
United States of America
State/province [4] 0 0
Texas
Country [5] 0 0
United States of America
State/province [5] 0 0
Utah
Country [6] 0 0
Belgium
State/province [6] 0 0
Leuven
Country [7] 0 0
Canada
State/province [7] 0 0
Ontario
Country [8] 0 0
Canada
State/province [8] 0 0
Quebec
Country [9] 0 0
Finland
State/province [9] 0 0
Helsinki
Country [10] 0 0
France
State/province [10] 0 0
Lyon Cedex 08
Country [11] 0 0
Italy
State/province [11] 0 0
Rozzano MI
Country [12] 0 0
Japan
State/province [12] 0 0
Saitama
Country [13] 0 0
Japan
State/province [13] 0 0
Shizuoka
Country [14] 0 0
Japan
State/province [14] 0 0
Tokyo
Country [15] 0 0
Netherlands
State/province [15] 0 0
Amsterdam
Country [16] 0 0
Spain
State/province [16] 0 0
Barcelona
Country [17] 0 0
Spain
State/province [17] 0 0
Madrid
Country [18] 0 0
Spain
State/province [18] 0 0
Pozuelo De AlarcOn Madr
Country [19] 0 0
Sweden
State/province [19] 0 0
Stockholm
Country [20] 0 0
United Kingdom
State/province [20] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
GlaxoSmithKline
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
US GSK Clinical Trials Call Center
Address 0 0
Country 0 0
Phone 0 0
877-379-3718
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement


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