Treatment of advanced or metastatic solid tumors with BGB-B455

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to evaluate the safety and efficacy of BGB-B455, a bispecific antibody targeting claudin 6 (CLDN6) on tumor cells and CD3 on T cells, in adults with advanced or metastatic solid tumors. The study is divided into two phases: Phase 1a focuses on dose escalation and safety expansion, while Phase 1b involves dose expansion at the optimal dose identified in Phase 1a. Participants will be monitored for adverse effects and the recommended dosing will be established. The trial is open-label, meaning both participants and researchers are aware of the treatment being administered.

Why it matters

Who can join: the full rules

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. 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.
* 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.

Where it's running

• Adventhealth
  Celebration, Florida, United States Recruiting
• Sidney Kimmel Cancer Center
  Philadelphia, Pennsylvania, United States Recruiting
• Avera Cancer Institute
  Sioux Falls, South Dakota, United States Recruiting
• Next Oncology
  San Antonio, Texas, United States Recruiting
• Fred Hutchinson Cancer Research Center
  Seattle, Washington, United States Recruiting
• Blacktown Cancer and Haematology Centre
  Blacktown, New South Wales, Australia Recruiting

Study contacts

• Study coordinator: Study Director
• Email: clinicaltrials@beonemed.com
• Phone: 1.877.828.5568

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.