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NCT06431594 | RECRUITING | Solid Tumors

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

GlaxoSmithKline

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.

Condition or disease

Solid Tumors

Neoplasms

Intervention/treatment

GSK5733584

Phase

PHASE1

Study Type : INTERVENTIONAL
Estimated Enrollment : 240 participants
Masking : NONE
Primary Purpose : TREATMENT
Official 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
Actual Study Start Date : 2024-07-02
Estimated Primary Completion Date : 2026-10-15
Estimated Study Completion Date : 2027-07-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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.
  • 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.
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.
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Clinical Activity of GSK5733584 for Injection in Participants With Advanced Solid Tumors

Location Details

NCT06431594

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Florida

GSK Investigational Site

Lake Mary, Florida, United States, 32746

RECRUITING

United States, Massachusetts

GSK Investigational Site

Boston, Massachusetts, United States, 02114

RECRUITING

United States, Massachusetts

GSK Investigational Site

Boston, Massachusetts, United States, 02215

RECRUITING

United States, Road cancer

GSK Investigational Site

Detroit, Road cancer, United States, 48201

RECRUITING

United States, Texas

GSK Investigational Site

Dallas, Texas, United States, 75230

RECRUITING

United States, Utah

GSK Investigational Site

West Valley City, Utah, United States, 84119

RECRUITING

Australia, New South Wales

GSK Investigational Site

Blacktown, New South Wales, Australia, 2148

RECRUITING

Australia, New South Wales

GSK Investigational Site

Macquarie University, New South Wales, Australia, 2109

RECRUITING

Belgium,

GSK Investigational Site

Leuven, Belgium, 3000

RECRUITING

Canada, Ontario

GSK Investigational Site

Ottawa, Ontario, Canada, K1h 8l6

RECRUITING

Canada, Ontario

GSK Investigational Site

Toronto, Ontario, Canada, M5G 2M9

RECRUITING

Canada, Quebec

GSK Investigational Site

Montreal, Quebec, Canada, H2X 0A9

RECRUITING

Finland,

GSK Investigational Site

Helsinki, Finland, 00290

RECRUITING

France,

GSK Investigational Site

Lyon Cedex 08, France, 69373

RECRUITING

Italy,

GSK Investigational Site

Rozzano mi, Italy, 20089

RECRUITING

Japan,

GSK Investigational Site

Saatama, Japan, 350-1298

RECRUITING

Japan,

GSK Investigational Site

Shizuoka, Japan, 411-8777

RECRUITING

Japan,

GSK Investigational Site

Tokyo, Japan, 135-8550

RECRUITING

Netherlands,

GSK Investigational Site

Amsterdam, Netherlands, 1066 CX

RECRUITING

Spain,

GSK Investigational Site

Barcelona, Spain, 08035

RECRUITING

Spain,

GSK Investigational Site

Madrid, Spain, 28040

RECRUITING

Spain,

GSK Investigational Site

Pozuelo de Alarcon Madrid, Spain, 28223

RECRUITING

Sweden,

GSK Investigational Site

Stockholm, Sweden, 17164

RECRUITING

United Kingdom,

GSK Investigational Site

London, United Kingdom, NW1 2PG