BEHOLD-1

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

Open
Grade
High grade, Low grade, Other / unknown
Prior lines
1, 2
Histology
Serous, Carcinocarcoma Endometrioid Other (bv. mixed/rare)
Phase
I
IMP
GSK5733584
principal investigator
Prof. Dr. Toon Van Gorp

Treatment

The treatment option in this study is GSK5733584.
The study is currently enrolling in the expansion phase.

Treatment duration

The treatment can continue until disease progression, unacceptable toxicity or withdrawal of consent.

Eligibility

Main inclusion criteria:

  • Histologically documented, advanced (metastatic and/or unresectable) or recurrent endometrial cancer
  • Must have received or are intolerant to 1 but no more than 2 lines of prior systemic therapy
  • Must have had prior platinum and PD(L)-1 inhibitor (in same regimen or in separate regimens), if considered a candidate for this regimen 
  • All epithelial histologies are permitted including carcinosarcoma
  • Participants have at least one target lesion as assessed per 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.

Main exclusion criteria:

  • Have received any of B7-H4-targeted therapies.
  • Presence of pleural/abdominal effusion/ascites requiring clinical intervention; presence of pericardial effusion
  • Any evidence of current Interstitial lung disease (ILD) or pneumonitis or a prior history of ILD or pneumonitis requiring high-dose systemic glucocorticoids.

Disclaimer: This is an overview of the main in- and exclusion criteria which can also be found on clinicaltrials.gov (NCT06431594). Criteria might change during the course of the study due to amendments. Inclusion in the trial remains the responsibility of the principal investigator of the trial and will depend on patient eligibility and slot availability.

Contact

In case you feel your patient might be eligible for this trial or in case you want to have more information about this trial, please feel free to contact us via: lgog@uzleuven.be