Home › Trials › NCT06431594

Evaluating GSK5733584 for advanced solid tumors

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

Phase 1 Interventional GlaxoSmithKline · NCT06431594

This study is testing a new injectable treatment called GSK5733584 to see if it's safe and how it works for people with advanced solid tumors that haven't responded to other treatments.

Quick facts

PhasePhase 1
Study typeInterventional
Enrollment385 (estimated)
Ages18 Years and up
SexAll
SponsorGlaxoSmithKline Industry-sponsored
Drugs / interventionsbevacizumab, mirvetuximab, chemotherapy, radiation
Locations47 sites (Lake Mary, Florida and 46 other locations)
Trial IDNCT06431594 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the safety and tolerability of GSK5733584, an injectable treatment for patients with advanced solid tumors. It will assess how the drug's levels change over time at various doses. Participants must have advanced solid tumors that have either failed standard treatments or are intolerant to them. The study focuses on specific cohorts, particularly those with high-grade serous or endometrioid ovarian cancer.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with advanced solid tumors who have failed or are intolerant to standard therapies.

Not a fit: Patients with early-stage solid tumors or those who have not yet undergone standard treatment may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced solid tumors who have limited treatment choices.

How similar studies have performed: Other studies have shown promise with similar approaches targeting advanced solid tumors, but the specific drug GSK5733584 is being evaluated for the first time in this context.

Eligibility criteria

Show full inclusion / exclusion 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.
* 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.

Where this trial is running

Lake Mary, Florida and 46 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Solid TumorsNeoplasmsGSK5733584
Last reviewed 2026-06-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.