A Study of BGB-B455 in Adults With Advanced or Metastatic Solid Tumors
Recruiting now · Phase 1
Conditions studied: Advanced Solid Tumor, Metastatic Solid Tumor
In brief
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
Key facts
- Study ID
- NCT06803680
- Run by
- BeOne Medicines
- People needed
- 90
- Starts
- 2025-03-18
- Expected to finish
- 2028-04-29
- Last updated by the study team
- 2026-07-08
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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 is running
- Shanxi Provincial Cancer Hospital — Taiyuan, Shanxi, China (enrolling)
- Sidney Kimmel Cancer Center — Philadelphia, Pennsylvania, United States (enrolling)
- Avera Cancer Institute — Sioux Falls, South Dakota, United States (enrolling)
- Next Oncology — San Antonio, Texas, United States (enrolling)
- Fred Hutchinson Cancer Research Center — Seattle, Washington, United States (enrolling)
- Blacktown Cancer and Haematology Centre — Blacktown, New South Wales, Australia (enrolling)
- Liverpool Hospital — Liverpool, New South Wales, Australia (enrolling)
- Fudan University Shanghai Cancer Centerpudong — Shanghai, Shanghai Municipality, China (enrolling)
- Adventhealth — Celebration, Florida, United States (enrolling)
- Sun Yat Sen University Cancer Center — Guangzhou, Guangdong, China (enrolling)
- The First Affiliated Hospital of Nanchang University Branch Donghu — Nanchang, Jiangxi, China (enrolling)
- Mater Cancer Care Centre — South Brisbane, Queensland, Australia
- Beijing Cancer Hospital — Beijing, Beijing Municipality, China
Full record on ClinicalTrials.gov
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