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

Last updated: June 20, 2025
Sponsor: BeiGene
Overall Status: Active - Recruiting

Phase

1

Condition

Neoplasms

Treatment

BGB-B455

Clinical Study ID

NCT06803680
BGB-B455-101
2024-512931-64-00
  • Ages > 18
  • All Genders

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 Criteria

Inclusion

Inclusion Criteria:

  • Histologically or cytologically confirmed advanced or metastatic, and unresectablesolid tumors who have previously received standard systemic therapy for advanced ormetastatic disease or for whom treatment is not available or not tolerated.

  • Agreement for collection of formalin-fixed paraffin-embedded (FFPE) tumor tissue forcentral CLDN6 testing and other biomarker assessments.

  • Tumor CLDN6 expression (CDLN6+) by central immunohistochemistry testing is requiredfor Phase 1a dose escalation Cohort 5 and higher.

  • ≥ 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

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 orChinese [or other country] patent medicines, ≤ 14 days or 5 half-lives (whichever isshorter) before the first dose of study drug(s).

  • Palliative radiation treatment or other locoregional therapies ≤ 14 days before thefirst dose of study drug(s).

  • Live vaccine ≤ 28 days before the first dose of study drug(s). Vaccines for COVID-19are allowed except for any live vaccine that may become available. Seasonal vaccinesfor influenza are generally inactivated vaccines and are allowed. Intranasalvaccines 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 notrecovered to baseline or stabilized, except for adverse events not considered alikely safety risk (eg, alopecia, neuropathy, and specific laboratoryabnormalities).

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Study Design

Total Participants: 80
Treatment Group(s): 1
Primary Treatment: BGB-B455
Phase: 1
Study Start date:
March 18, 2025
Estimated Completion Date:
October 30, 2027

Study Description

Claudin proteins are cell proteins that can play an important role in how cancer starts and progresses. Because of its preferential expression in tumors compared to normal tissues, CLDN6 is an ideal tumor antigen to target for treatment. BGB-B455 is a bispecific antibody (BsAbs) that targets CLDN6 on tumor cells and the CD3 receptor on T cells, which may provide a CLDN6-dependent antitumor immune response in a more tolerable manner without undue systemic toxicity.

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 in participants with 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.

Connect with a study center

  • Blacktown Cancer and Haematology Centre

    Blacktown, New South Wales 2148
    Australia

    Active - Recruiting

  • Liverpool Hospital

    Liverpool, New South Wales 2170
    Australia

    Site Not Available

  • Mater Cancer Care Centre

    South Brisbane, Queensland 4101
    Australia

    Site Not Available

  • Beijing Cancer Hospital

    Beijing, Beijing 100142
    China

    Site Not Available

  • Sun Yat Sen University Cancer Center

    Guangzhou, Guangdong 510060
    China

    Site Not Available

  • The First Affiliated Hospital of Nanchang University Branch Donghu

    Nanchang, Jiangxi 330006
    China

    Site Not Available

  • Fudan University Shanghai Cancer Centerpudong

    Shanghai, Shanghai 201321
    China

    Active - Recruiting

  • Shanxi Provincial Cancer Hospital

    Taiyuan, Shanxi 030013
    China

    Site Not Available

  • Adventhealth

    Celebration, Florida 34747-4606
    United States

    Site Not Available

  • Florida Cancer Specialists and Research Institute

    Lake Mary, Florida 32746-2115
    United States

    Active - Recruiting

  • Sidney Kimmel Cancer Center

    Philadelphia, Pennsylvania 19107-4307
    United States

    Site Not Available

  • Avera Cancer Institue

    Sioux Falls, South Dakota 57105-2108
    United States

    Site Not Available

  • Avera Cancer Institute

    Sioux Falls, South Dakota 57105-2108
    United States

    Site Not Available

  • Next Oncology

    San Antonio, Texas 78229-6028
    United States

    Active - Recruiting

  • Ut Health San Antonio Mays Cancer Center

    San Antonio, Texas 78229-4427
    United States

    Site Not Available

  • Fred Hutchinson Cancer Research Center

    Seattle, Washington 98109-4433
    United States

    Site Not Available

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