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

Last updated: February 17, 2025
Sponsor: GlaxoSmithKline
Overall Status: Active - Recruiting

Phase

1

Condition

Solid Tumors

Neoplasms

Treatment

GSK5733584

Clinical Study ID

NCT06431594
222730
2024-513860-25
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Males or females aged 18 years or older (≥18 years).

  • Participants with pathologically confirmed advanced solid tumor (who have failed orare intolerant to standard of care).

  • PROC cohort

  1. Histologically documented, advanced (metastatic and/or unresectable) high-gradeserous/endometrioid ovarian, primary peritoneal, or fallopian tube cancer.

  2. Must have received or are intolerant to 1 but no more than 3 lines of priorsystemic therapy.

  3. Platinum-resistant disease, defined as progression or relapse within 6 monthsafter the completion of platinum-based therapy.

  4. Must have had prior bevacizumab if the participant was considered a candidatefor this regimen and the regimen is locally available.

  5. Participants with known Folate receptor-α (FR-α) expressing tumors must havereceived mirvetuximab soravtasine if the participants was considered acandidate for this regimen and the regimen is locally available.

  6. Participants with known Breast cancer susceptibility gene (BRCA) mutated tumorsshould have received a Poly adenosine diphosphate-ribose polymerase (PARP)inhibitor if the participant was considered a candidate for this regimen andthe 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) orrecurrent endometrial cancer.

  2. Must have received or are intolerant to 1 but no more than 2 lines of priorsystemic therapy.

  3. Must have had prior platinum and PD(L)-1 inhibitor (in same regimen or inseparate regimens), if considered a candidate for this regimen and the regimenis 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 forretrospective detection of B7 homolog 4 (B7-H4) expression by Immunohistochemistry (IHC) in central laboratory and other biomarker analysis. Tissue from a newlyobtained biopsy is preferred. If a newly obtained biopsy is not feasible, archivaltumor 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 andno deterioration within 2 weeks before the first dose.

  • Have a life expectancy of at least 12 weeks.

Exclusion

Exclusion Criteria:

  • Have received any of B7-H4-targeted therapies.

  • Have received any of cytotoxic chemotherapy drugs, anti-tumor traditional Chinesemedicines or other anti-tumor drugs within 28 days prior to the first dose of studydrug; or need to continue these drugs during the study.

  • Have received locoregional radiation therapy within 2 weeks prior to the first doseof study drug; more than 30% of bone marrow irradiation or wide-field radiationtherapy 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 restingECG.

  • 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 poorlycontrolled hypertension, clinically significant bleeding symptoms or seriousarteriovenous thromboembolic events

  • Any evidence of current Interstitial lung disease (ILD) or pneumonitis or a priorhistory of ILD or pneumonitis requiring high-dose systemic glucocorticoids.

  • Have received prior therapy with topoisomerase inhibitors or topoisomerase inhibitorAntibody-drug conjugate (ADCs)

  • PROC

  1. Primary platinum refractory not permitted.

  2. Non-epithelial carcinoma, clear-cell, mucinous, germ-cell, low-grade serous, orlow-grade endometrioid carcinoma not permitted.

  • Endometrial cancer a. Mesenchymal tumors of the uterus (uterine sarcomas) notpermitted.

Study Design

Total Participants: 240
Treatment Group(s): 1
Primary Treatment: GSK5733584
Phase: 1
Study Start date:
July 02, 2024
Estimated Completion Date:
July 01, 2027

Connect with a study center

  • GSK Investigational Site

    Blacktown, New South Wales 2148
    Australia

    Active - Recruiting

  • GSK Investigational Site

    Macquarie University, New South Wales 2109
    Australia

    Active - Recruiting

  • GSK Investigational Site

    Sydney, New South Wales 2109
    Australia

    Site Not Available

  • GSK Investigational Site

    Leuven, 3000
    Belgium

    Active - Recruiting

  • GSK Investigational Site

    Ottawa, Ontario K1H 8L6
    Canada

    Active - Recruiting

  • GSK Investigational Site

    Toronto, Ontario M5G 2M9
    Canada

    Active - Recruiting

  • GSK Investigational Site

    Montreal, Quebec H2X 0A9
    Canada

    Active - Recruiting

  • GSK Investigational Site

    Montréal, Quebec H2X 0A9
    Canada

    Site Not Available

  • GSK Investigational Site

    Helsinki, 00290
    Finland

    Active - Recruiting

  • GSK Investigational Site

    Lyon Cedex 08, 69373
    France

    Active - Recruiting

  • GSK Investigational Site

    Napoli, 80131
    Italy

    Site Not Available

  • GSK Investigational Site

    Roma, 00168
    Italy

    Site Not Available

  • GSK Investigational Site

    Rozzano MI, 20089
    Italy

    Active - Recruiting

  • GSK Investigational Site

    Saitama, 350-1298
    Japan

    Active - Recruiting

  • GSK Investigational Site

    Shizuoka, 411-8777
    Japan

    Active - Recruiting

  • GSK Investigational Site

    Tokyo, 135-8550
    Japan

    Active - Recruiting

  • GSK Investigational Site

    Amsterdam, 1066 CX
    Netherlands

    Active - Recruiting

  • GSK Investigational Site

    Barcelona, 08035
    Spain

    Active - Recruiting

  • GSK Investigational Site

    Madrid, 28040
    Spain

    Active - Recruiting

  • GSK Investigational Site

    Pozuelo De AlarcOn Madr, 28223
    Spain

    Active - Recruiting

  • GSK Investigational Site

    Stockholm, 17164
    Sweden

    Active - Recruiting

  • GSK Investigational Site

    Cambridge, CB2 0QQ
    United Kingdom

    Site Not Available

  • GSK Investigational Site

    London, NW1 2PG
    United Kingdom

    Active - Recruiting

  • GSK Investigational Site

    Lake Mary, Florida 32746
    United States

    Active - Recruiting

  • GSK Investigational Site

    Boston, Massachusetts 02114
    United States

    Active - Recruiting

  • GSK Investigational Site

    Detroit, Michigan 48201
    United States

    Active - Recruiting

  • GSK Investigational Site

    Dallas, Texas 75230
    United States

    Active - Recruiting

  • GSK Investigational Site

    West Valley City, Utah 84119
    United States

    Active - Recruiting

  • GSK Investigational Site

    Seattle, Washington 98109-1023
    United States

    Site Not Available

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