A Study of BGB-B455 in Adults With Advanced or Metastatic Solid Tumors

Launched by BEIGENE · Jan 27, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called BGB-B455 for adults with advanced or metastatic solid tumors, which are types of cancer that have spread and cannot be surgically removed. The main goal is to find out the best dose of BGB-B455 and to understand any side effects that participants may experience. The trial is divided into two phases: the first part focuses on gradually increasing the dose and assessing safety, while the second part looks at more participants at a determined dose.

To be eligible for this trial, participants should have a confirmed diagnosis of advanced or metastatic solid tumors that have not responded to standard treatments or where those treatments are not available. They also need to have tumor samples available for testing and show stable health status. Participants can expect to receive the study drug and be closely monitored for any side effects and effectiveness. It's important to note that certain prior treatments and conditions may prevent someone from joining the trial, so discussing eligibility with a healthcare provider is crucial.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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.
• • 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.
• • Stable Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
• • Adequate organ function.
• Exclusion Criteria:
• • 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).
• • History of prior ≥ Grade 3 cytokine release syndrome (CRS).
• • Participants with toxicities (because of prior anticancer therapy) that have not recovered to baseline or stabilized, except for adverse events not considered a likely safety risk (eg, alopecia, neuropathy, and specific laboratory abnormalities).
• • Note: Other protocol defined Inclusion/Exclusion criteria may apply.