A Study of BGB-B455 in Adults With Advanced or Metastatic Solid Tumors
NCT ID: NCT06803680
Last Updated: 2025-11-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
90 participants
INTERVENTIONAL
2025-03-18
2027-10-30
Brief Summary
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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
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Detailed Description
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This new study will check how safe and helpful this potential anticancer drug is. In addition, this study will explore the recommended dosing level for BGB-B455. This drug will be tested by itself or in combination with investigator-selected chemotherapy in participants with selected solid tumors expressing the CLDN6 protein.
This study is an open label study, meaning that both you and your study doctor will know what study drug/treatment you are given. This study has two parts:
* Phase 1a consists of a dose escalation part where increasing amounts of the study treatment are given to different dose cohorts, and a safety expansion part that will enroll additional participants at selected doses for further assessments.
* Phase 1b (dose expansion) will enroll participants at the best dose found in Phase 1a to see if it helps people with certain solid tumors.
Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Phase 1a: Dose Escalation and Safety Expansion
Sequential cohorts of increasing dose levels of BGB-B455 will be evaluated as monotherapy.
BGB-B455
Planned doses administered on specified days per protocol.
Phase 1b: Dose Expansion
Recommended Dose(s) for Expansion (RDFE\[s\]) of BGB-B455 determined from Phase 1a as monotherapy or in combination with investigator-selected chemotherapy will be evaluated for selected indications based on emerging data.
BGB-B455
Planned doses administered on specified days per protocol.
Chemotherapy
Administered in accordance with relevant local guidelines and/or prescribing information.
Interventions
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BGB-B455
Planned doses administered on specified days per protocol.
Chemotherapy
Administered in accordance with relevant local guidelines and/or prescribing information.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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).
18 Years
ALL
No
Sponsors
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BeiGene
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
BeiGene
Locations
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Adventhealth
Celebration, Florida, United States
Florida Cancer Specialists and Research Institute
Lake Mary, Florida, United States
Sidney Kimmel Cancer Center
Philadelphia, Pennsylvania, United States
Avera Cancer Institute
Sioux Falls, South Dakota, United States
Next Oncology
Austin, Texas, United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States
Blacktown Cancer and Haematology Centre
Blacktown, New South Wales, Australia
Liverpool Hospital
Liverpool, New South Wales, Australia
Mater Cancer Care Centre
South Brisbane, Queensland, Australia
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
Sun Yat Sen University Cancer Center
Guangzhou, Guangdong, China
The First Affiliated Hospital of Nanchang University Branch Donghu
Nanchang, Jiangxi, China
Fudan University Shanghai Cancer Centerpudong
Shanghai, Shanghai Municipality, China
Shanxi Provincial Cancer Hospital
Taiyuan, Shanxi, China
Countries
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Central Contacts
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Other Identifiers
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2024-512931-64-00
Identifier Type: CTIS
Identifier Source: secondary_id
CTR20251939
Identifier Type: REGISTRY
Identifier Source: secondary_id
BGB-B455-101
Identifier Type: -
Identifier Source: org_study_id
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