A Study of BGB-B455 in Adults With Advanced or Metastatic Solid Tumors
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorBeOne Medicines
About this trial
The goal of this clinical trial is to learn if BGB-B455 can treat advanced or metastatic solid tumors expressing claudin 6 (CLDN6), a protein that is found on some tumors.
The main questions it aims to answer are:
* What is the recommended dosing for BGB-B455? * What medical problems do participants have when taking BGB-B455?
The study has two parts:
* Phase 1a: dose escalation and safety expansion * Phase 1b: dose expansion
Eligibility criteria
Qualifiers
Histologically or cytologically confirmed advanced or metastatic, and unresectable solid tumors who have previously received standard systemic therapy for advanced or metastatic disease or for whom treatment is not available or not tolerated. Only participants with CLDN6+ high-grade OC (ie, ovarian cancer, fallopian tube cancer, or primary peritoneal cancer) will be enrolled in dose escalation cohorts, starting from Protocol Amendment 3.0.
Agreement for collection of formalin-fixed paraffin-embedded (FFPE) tumor tissue for central CLDN6 testing and other biomarker assessments.
Tumor CLDN6 expression (CDLN6+) by central immunohistochemistry testing is required for certain cohorts.
≥ 1 measurable lesion as assessed by RECIST v1.1.
Disqualifiers
Prior systemic anticancer therapy, including chemotherapy, immunotherapy (eg, interleukin, interferon, thymosin), targeted therapy, and antibody drug conjugates (ADCs) that are standard or investigational agents (including herbal medicine or Chinese [or other country] patent medicines, ≤ 14 days or 5 half-lives (whichever is shorter) before the first dose of study drug(s).
Palliative radiation treatment or other locoregional therapies ≤ 14 days before the first dose of study drug(s).
Live vaccine ≤ 28 days before the first dose of study drug(s). Vaccines for COVID-19 are allowed except for any live vaccine that may become available. Seasonal vaccines for influenza are generally inactivated vaccines and are allowed. Intranasal vaccines are live vaccines and are not allowed.
Any major surgical procedure ≤ 28 days before the first dose of study drug(s).
Trial design
Treatments tested in this trial
- BGB-B455
- Chemotherapy
Treatment groups
90 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov