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Clinical Trials in China / NCT06803680
Recruiting Phase 1

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

NCT06803680 · tracked via the Priya Life Science China tracker
Sponsor
BeOne Medicines
Phase
Phase 1
Started
2025-03-18
Last updated
2026-08-24

Condition(s) studied

Advanced Solid TumorMetastatic Solid Tumor

Investigational drug(s) / intervention(s)

BGB-B455Chemotherapy

BGB-B455: Planned doses administered on specified days per protocol.

Chemotherapy: Administered in accordance with relevant local guidelines and/or prescribing information.

Study summary

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (11)

FacilityCityRegionStatus
Adventhealth Celebration Florida Recruiting
Sidney Kimmel Cancer Center Philadelphia Pennsylvania Recruiting
Avera Cancer Institute Sioux Falls South Dakota Recruiting
Next Oncology San Antonio Texas Recruiting
Fred Hutchinson Cancer Research Center Seattle Washington Recruiting
Blacktown Cancer and Haematology Centre Blacktown New South Wales Recruiting
Liverpool Hospital Liverpool New South Wales Recruiting
Beijing Cancer Hospital Beijing Beijing Municipality Completed
The First Affiliated Hospital of Nanchang University Branch Donghu Nanchang Jiangxi Recruiting
Fudan University Shanghai Cancer Centerpudong Shanghai Shanghai Municipality Recruiting
Shanxi Provincial Cancer Hospital Taiyuan Shanxi Recruiting

More BeOne Medicines trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06803680 on ClinicalTrials.gov ↗ ← All trials in China