RecruitingPhase 1NCT06803680

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

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


Sponsor

BeOne Medicines

Enrollment

90 participants

Start Date

Mar 18, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This early-phase clinical trial studies BGB-B455, a new type of cancer immunotherapy drug called a bispecific antibody, in adults with advanced or metastatic solid tumors that express a protein called claudin 6 (CLDN6) on their tumor cells. The drug is designed to connect CLDN6-positive cancer cells with immune T cells to trigger a targeted immune attack against the tumor. Adults with advanced solid tumors who have already received standard treatments (or for whom no standard treatment is available), have good functional status, and whose tumors test positive for CLDN6 may be eligible. Participation involves receiving BGB-B455 infusions either alone or in combination with chemotherapy, with the main goals being to determine a safe and effective dose and to monitor for side effects. This summary was generated with AI assistance to help patients understand the study in plain language.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGBGB-B455

Planned doses administered on specified days per protocol.

DRUGChemotherapy

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


Locations(13)

Adventhealth

Celebration, Florida, United States

Sidney Kimmel Cancer Center

Philadelphia, Pennsylvania, United States

Avera Cancer Institute

Sioux Falls, South Dakota, United States

Next Oncology

San Antonio, 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

View Full Details on ClinicalTrials.gov

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NCT06803680


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