Treatment of advanced or metastatic solid tumors with BGB-B455
A Phase 1, Open-Label Study Investigating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of BGB-B455 in Patients With Selected Advanced or Metastatic Solid Tumors
This study is testing a new treatment called BGB-B455 to see if it can help adults with advanced or metastatic solid tumors feel better and improve their condition.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | BeOne Medicines Industry-sponsored |
| Drugs / interventions | chemotherapy, immunotherapy, radiation |
| Locations | 13 sites (Celebration, Florida and 12 other locations) |
| Trial ID | NCT06803680 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults with advanced or metastatic solid tumors that express CLDN6 and have previously received standard systemic therapy.
Not a fit: Patients with solid tumors that do not express CLDN6 or those who have not tolerated prior systemic anticancer therapies may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced solid tumors expressing CLDN6.
How similar studies have performed: While this approach is novel in targeting CLDN6 with a bispecific antibody, similar studies targeting other tumor antigens have shown promise.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Celebration, Florida and 12 other locations
- 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)
- Liverpool Hospital — Liverpool, New South Wales, Australia (Recruiting)
- Mater Cancer Care Centre — South Brisbane, Queensland, Australia (Recruiting)
- Beijing Cancer Hospital — Beijing, Beijing Municipality, China (Completed)
- Sun Yat Sen University Cancer Center — Guangzhou, Guangdong, China (Recruiting)
- The First Affiliated Hospital of Nanchang University Branch Donghu — Nanchang, Jiangxi, China (Recruiting)
- Fudan University Shanghai Cancer Centerpudong — Shanghai, Shanghai Municipality, China (Recruiting)
- Shanxi Provincial Cancer Hospital — Taiyuan, Shanxi, China (Recruiting)
Study contacts
- Study coordinator: Study Director
- Email: clinicaltrials@beigene.com
- Phone: 1.877.828.5568
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.