BEHOLD-2

A Phase I/II Randomized Multi-Cohort Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Clinical Activity of GSK5733584 in Combination with Anti-Cancer Agents in Participants with Advanced Solid Tumors

Open
Grade
High grade, Low grade
Prior lines
1, 2, 3, 4
Histology
Serous, Mucinous Endometrioid Clear-cell Carcinocarcoma
Platin
Platinum resistant
Secondary platinum refractory
Platinum sensitive
Primary platinum refractory
Phase
I/II
IMP
GSK5733584 + bevacizumab
principal investigator
Prof. Dr. Toon Van Gorp

Treatment

The treatment option in this study is GSK5733584 + bevacizumab.
 

Treatment duration

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

Eligibility

Main inclusion criteria:

  • Histologically or cytologically confirmed advanced epithelial ovarian cancer/fallopian tube/peritoneal cancer (any epithelial histology – mucinous, clear cell, carcinosarcoma, high/low grade serous, endometrioid) who have failed in adequate standard treatments, do not have effective standard treatment or are intolerant to standard of care
  • No more than 4 lines of prior systemic therapies
  • Participants have at least one target lesion as assessed per RECIST 1.1
  • Archival or fresh tumor tissue is required for retrospective central assessment of B7H4 expression by IHC and other biomarker analysis.

Main exclusion criteria:

  • Have received prior therapy with topoisomerase inhibitors or ADC with topoisomerase inhibitor warhead, or B7H4 targeted therapy.
  • Any evidence of current interstitial lung disease (ILD) or pneumonitis or a prior history of ILD or non-infectious pneumonitis.

Disclaimer: This is an overview of the main in- and exclusion criteria which can also be found on clinicaltrials.gov (NCT06796907). 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