A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Clinical Activity of GSK5733584 for Injection in Participants With Advanced Solid Tumors (BEHOLD-1)

May 19, 2026 updated by: GlaxoSmithKline

A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Clinical Activity of GSK5733584 for Injection in Subjects With Advanced Solid Tumors

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

675

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Argentina
      • Cipoletti Rio Negro, Argentina, R8324CVE
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Andres Guercovich
      • Ciudad de Buenos Aires, Argentina, 1118
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Mercedes Tamburelli
      • La Plata, Argentina, B1900AVG
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Fabiana Marmissolle
      • Rosario, Argentina, S2002
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Cristina Nasurdi
  • Australia
    • New South Wales
      • Blacktown, New South Wales, Australia, 2148
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Phuong Dinh
      • Macquarie University, New South Wales, Australia, 2109
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Dhanusha Sabanathan
  • Belgium
      • Leuven, Belgium, 3000
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Toon van Gorp
        • Contact:
        • Contact:
  • Brazil
      • Barretos, Brazil, 14784-400
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ana Suellen Carneiro
      • Goiânia, Brazil, 74605-070
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ruffo de Freitas Júnior
      • Rio de Janeiro, Brazil, 20220-410
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Andreia Melo
  • Canada
    • Ontario
      • Ottawa, Ontario, Canada, K1H 8L6
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • John Hilton
        • Contact:
        • Contact:
      • Toronto, Ontario, Canada, M5G 2M9
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Stephanie Lheureux
      • Toronto, Ontario, Canada, M4N 3M5
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Helen MacKay
        • Contact:
        • Contact:
    • Quebec
      • Montreal, Quebec, Canada, H3T 1E2
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Kim Ma
      • Montreal, Quebec, Canada, H2X 0A9
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Principal Investigator:
          • Diane Provencher
        • Contact:
  • Finland
      • Helsinki, Finland, 00180
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Johanna Maenpaa
        • Contact:
        • Contact:
      • Helsinki, Finland, 00290
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Katriina Jalkanen
      • Tampere, Finland, 33520
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Synnove Staff
  • France
      • Lyon, France, 69373
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Isabelle Ray Coquard
      • Saint-Herblain, France, 44805
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Jean-Sébastien FRENEL
        • Contact:
        • Contact:
      • Villejuif, France, 94805
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Alexandra LEARY
  • Italy
      • Aviano PN, Italy, 33081
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Michele Bartoletti
      • Milan, Italy, 20141
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Giuseppe Curigliano
      • Milan, Italy, 20159
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Domenica Lorusso
      • Naples, Italy, 80131
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Adriano Gravina
        • Contact:
        • Contact:
      • Roma, Italy, 00168
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Vanda Salutari
        • Contact:
        • Contact:
  • Japan
      • Saitama, Japan, 350-1298
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Kosei Hasegawa
      • Shizuoka, Japan, 411-8777
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Kentaro Yamazaki
      • Tokyo, Japan, 135-8550
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Shigehisa Kitano
        • Contact:
        • Contact:
  • Netherlands
      • Amsterdam, Netherlands, 1066 CX
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Marloes G.J. van Rijn-van Dongen
  • South Korea
      • Gyeonggi-do, South Korea, 10408
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Myong Cheol Lim
      • Seoul, South Korea, 03080
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Jae-Weon Kim
        • Contact:
        • Contact:
      • Seoul, South Korea, 03722
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jung-Yun Lee
      • Seoul, South Korea, 06351
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jeong-Won Lee
  • Spain
      • Barcelona, Spain, 08035
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Lorena Fariñas Madrid
      • Córdoba, Spain, 14004
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • María Jesús Rubio Perez
        • Contact:
        • Contact:
      • Girona, Spain, 17007
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Pilar Barretina
      • Madrid, Spain, 28046
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Andres Redondo Sanchez
      • Madrid, Spain, 28034
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Eva Maria Guerra Alia
      • Madrid, Spain, 28040
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Victor Moreno
        • Contact:
        • Contact:
      • Madrid, Spain, 28027
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Antonio González Martín
      • Pozuelo de AlarcOn Madr, Spain, 28223
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Valentina Boni
        • Contact:
        • Contact:
  • Sweden
      • Stockholm, Sweden, 17164
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Lisa Liu Burstrom
      • Uppsala, Sweden, SE-751 85
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Anthoula Koliadi
  • United Kingdom
      • Cambridge, United Kingdom, CB2 0QQ
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Joo Ern Ang
      • London, United Kingdom, W1G 6AD
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Anja Williams
        • Contact:
        • Contact:
      • London, United Kingdom, NW1 2PG
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Rowan Miller
        • Contact:
        • Contact:
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Charles Leath
        • Contact:
        • Contact:
    • California
      • Fountain Valley, California, United States, 92708
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Amol Rao
        • Contact:
        • Contact:
      • Santa Rosa, California, United States, 95403
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ian Anderson
    • Florida
      • Lake Mary, Florida, United States, 32746
        • Completed
        • GSK Investigational Site
      • Orlando, Florida, United States, 32827
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Cesar Perez Batista
        • Contact:
        • Contact:
    • Kansas
      • Fairway, Kansas, United States, 66205
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Andrea Jewell
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Sara Bouberhan
        • Contact:
        • Contact:
      • Boston, Massachusetts, United States, 02215
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Elizabeth Lee
        • Contact:
        • Contact:
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ira Winer
      • Grand Rapids, Michigan, United States, 49546
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Nehal Lakhani
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Deanna Teoh
    • New York
      • Mineola, New York, United States, 11501
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Principal Investigator:
          • Bhavana Pothuri
        • Contact:
      • New York, New York, United States, 10016
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Principal Investigator:
          • Bhavana Pothuri
        • Contact:
    • Oregon
      • Portland, Oregon, United States, 97213
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Christopher Darus
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Denise Yardley
    • Texas
      • Dallas, Texas, United States, 75230
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Reva Schneider
    • Utah
      • West Valley City, Utah, United States, 84119
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • William McKean
    • Washington
      • Seattle, Washington, United States, 98104
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Fernanda Musa
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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-α (FR-α) 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.

  • 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 3 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. 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.

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 28 days 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 disease defined as those who have progressed on or within 12 weeks of last dose of first line platinum therapy 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Part 1: Dose Escalation
Participants with advanced solid tumors who are refractory or intolerant to established standard therapies
Drug: GSK5733584
GSK5733584 will be administered
Experimental: Part 2: Dose Expansion
Participants with platinum-resistant ovarian cancer (PROC) and endometrial cancer (EC)
Drug: GSK5733584
GSK5733584 will be administered

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Part 1: Number of participants with dose limiting toxicity (DLT)
Time Frame: Up to 21 days
Up to 21 days
Part 2: Confirmed Objective Response Rate (ORR)
Time Frame: Up to approximately 28 months
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)
Up to approximately 28 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Part 1 and 2: Duration of response (DoR)
Time Frame: Up to approximately 31 months
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
Up to approximately 31 months
Part 1 and 2: Progression-free survival (PFS)
Time Frame: Up to approximately 31 months
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).
Up to approximately 31 months
Part 1 and 2: Titers of ADA to GSK5733584
Time Frame: Up to approximately 31 months
Up to approximately 31 months
Part 1 and 2: Change from baseline in body temperature (degree Celsius)
Time Frame: Baseline (Day -1) and up to approximately 31 months
Baseline (Day -1) and up to approximately 31 months
Part 1 and 2: Change from baseline in respiratory rate (breaths per minute)
Time Frame: Baseline (Day -1) and up to approximately 31 months
Baseline (Day -1) and up to approximately 31 months
Part 1 and 2: Change from baseline in pulse rate (beats per minute)
Time Frame: Baseline (Day -1) and up to approximately 31 months
Baseline (Day -1) and up to approximately 31 months
Part 1 and 2: Change from baseline in blood pressure [millimetres of mercury (mmHg)]
Time Frame: Baseline (Day -1) and up to approximately 31 months
Baseline (Day -1) and up to approximately 31 months
Part 1 and 2: Change from baseline in weight [kilogram (kg)]
Time Frame: Baseline (Day -1) and up to approximately 31 months
Baseline (Day -1) and up to approximately 31 months
Part 1 and 2: Change from baseline in white blood cell count (cells per microliter)
Time Frame: Baseline (Day -1) and up to approximately 31 months
Baseline (Day -1) and up to approximately 31 months
Part 1 and 2: Change from baseline in hemoglobin (grams per deciliter)
Time Frame: Baseline (Day -1) and up to approximately 31 months
Baseline (Day -1) and up to approximately 31 months
Part 1 and 2: Change from Baseline in Platelet count (cells per microliter)
Time Frame: Baseline (Day -1) and up to approximately 31 months
Baseline (Day -1) and up to approximately 31 months
Part 1 and 2: Change from Baseline in Red Blood Cell Count (RBC) (million cells per microliter)
Time Frame: Baseline (Day -1) and up to approximately 31 months
Baseline (Day -1) and up to approximately 31 months
Part 1 and 2: Change from Baseline in haematocrit (Proportion of red blood cells in blood)
Time Frame: Baseline (Day -1) and up to approximately 31 months
Baseline (Day -1) and up to approximately 31 months
Part 1 and 2: Change from Baseline in Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils (giga cells per litre)
Time Frame: Baseline (Day -1) and up to approximately 31 months
Baseline (Day -1) and up to approximately 31 months
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)
Time Frame: Baseline (Day -1) and up to approximately 31 months
Baseline (Day -1) and up to approximately 31 months
Part 1 and 2: Change from Baseline in AST/SGOT, ALT/ SGPT, ALP and CPK (International Units per litre)
Time Frame: Baseline (Day -1) and up to approximately 31 months
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
Baseline (Day -1) and up to approximately 31 months
Part 1 and 2: Change from baseline in Total Protein and Albumin (Grams per deciliter)
Time Frame: Baseline (Day -1) and up to approximately 31 months
Baseline (Day -1) and up to approximately 31 months
Part 1 and 2: Change from baseline in Amylase and Lipase (Units per liter)
Time Frame: Baseline (Day -1) and up to approximately 31 months
Baseline (Day -1) and up to approximately 31 months
Part 1 and 2: Change from baseline in liver panel parameter: International Normalized Ratio (INR)
Time Frame: Baseline (Day -1) and up to approximately 31 months
Baseline (Day -1) and up to approximately 31 months
Part 1 and 2: Change from baseline in routine urine tests: Leukocyte esterase
Time Frame: Baseline (Day -1) and up to approximately 31 months
Leukocyte esterase measured as negative or positive
Baseline (Day -1) and up to approximately 31 months
Part 1 and 2: Change from baseline in routine urine tests: Occult blood (10^9 Cells Per Liter)
Time Frame: Baseline (Day -1) and up to approximately 31 months
Baseline (Day -1) and up to approximately 31 months
Part 1 and 2: Change from baseline in routine urine tests: potential of hydrogen (pH) value
Time Frame: Baseline (Day -1) and up to approximately 31 months
Baseline (Day -1) and up to approximately 31 months
Part 1 and 2: Change from baseline in routine urine tests: Protein and bilirubin (Grams Per Liter)
Time Frame: Baseline (Day -1) and up to approximately 31 months
Baseline (Day -1) and up to approximately 31 months
Part 1 and 2: Change From Baseline in routine urine tests: Specific Gravity (Ratio)
Time Frame: Baseline (Day -1) and up to approximately 31 months
Baseline (Day -1) and up to approximately 31 months
Part 1 and 2: Change from baseline in Electrocardiogram (ECG) readings [milliseconds (msec)]
Time Frame: Baseline (Day -1) and up to approximately 31 months
Baseline (Day -1) and up to approximately 31 months
Part 1 and 2: Change from baseline in Left ventricular ejection fraction (LVEF) [Percentage]
Time Frame: Baseline (Day -1) and up to approximately 31 months
Baseline (Day -1) and up to approximately 31 months
Part 1 and 2: Change from baseline in Eastern Cooperative Oncology Group Performance Scale (ECOG PS) score
Time Frame: Baseline (Day -1) and up to approximately 31 months
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.
Baseline (Day -1) and up to approximately 31 months
Part 2: Overall Survival (OS)
Time Frame: Up to approximately 31 months
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
Up to approximately 31 months
Part 1 and 2: Maximum observed concentration (Cmax) of GSK5733584 and its components: conjugated antibody, total antibody, and small molecule toxin
Time Frame: Up to approximately 31 months
Up to approximately 31 months
Part 1 and 2: Time to reach Cmax (Tmax) of GSK5733584 and its components: conjugated antibody, total antibody, and small molecule toxin
Time Frame: Up to approximately 31 months
Up to approximately 31 months
Part 1 and 2: Area under the concentration-time curve (AUC) of GSK5733584 and its components: conjugated antibody, total antibody, and small molecule toxin
Time Frame: Up to approximately 31 months
Up to approximately 31 months
Part 1: Confirmed Objective Response Rate (ORR)
Time Frame: Up to approximately 31 months
ORR is defined as the proportion of participants with at least one confirmed CR or PR as defined by RECIST 1.1
Up to approximately 31 months
Part 1 and 2:Number of participants with treatment-emergent Anti-drug antibodies (ADA)/ Neutralizing antibody (NAb)
Time Frame: Up to approximately 31 months
Up to approximately 31 months
Part 1 and 2: Number of participants with Adverse Events (AEs), and Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs)
Time Frame: Up to approximately 31 months
Up to approximately 31 months
Part 1 and 2: Change from baseline in Prothrombin Time (PT), Partial thromboplastin time (PTT) or Activated Partial Thromboplastin Time (aPTT) (seconds)
Time Frame: Baseline (Day -1) and up to approximately 31 months
Baseline (Day -1) and up to approximately 31 months
Part 1 and 2: Change from baseline in Thyroid stimulating hormone (TSH) [microunits per milliliter (µU/mL)]
Time Frame: Baseline (Day -1) and up to approximately 31 months
Baseline (Day -1) and up to approximately 31 months
Part 1 and 2: Change from baseline in free thyroxine (T4) [nanograms per deciliter (ng/dL)]
Time Frame: Baseline (Day -1) and up to approximately 31 months
Baseline (Day -1) and up to approximately 31 months
Part 1 and 2: Change from baseline in CA-125 tumor marker among ovarian cancer participants [units per milliliter (U/mL)]
Time Frame: Baseline (Day -1) and up to approximately 31 months
Baseline (Day -1) and up to approximately 31 months
Part 1 and 2: Change from baseline in Estimated glomerular filtration rate (eGFR) (milliliter per minute)
Time Frame: Baseline (Day -1) and up to approximately 31 months
Baseline (Day -1) and up to approximately 31 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 2, 2024

Primary Completion (Estimated)

September 22, 2027

Study Completion (Estimated)

December 31, 2029

Study Registration Dates

First Submitted

May 21, 2024

First Submitted That Met QC Criteria

May 22, 2024

First Posted (Actual)

May 28, 2024

Study Record Updates

Last Update Posted (Actual)

May 22, 2026

Last Update Submitted That Met QC Criteria

May 19, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 222730
  • 2024-513860-25 (Registry Identifier: CTIS)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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/

IPD Sharing Time Frame

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.

IPD Sharing Access Criteria

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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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