RECRUITING

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

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Conditions

Advanced Solid TumorMetastatic Solid TumorClaudin-6CLDN6+advanced or metastatic solid tumorCD3BsAbbispecific antibodyCD3-BsAbCLDN

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2025-03-18
Study Completion:2027-10-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06803680

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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.
  2. * Agreement for collection of formalin-fixed paraffin-embedded (FFPE) tumor tissue for central CLDN6 testing and other biomarker assessments.
  3. * Tumor CLDN6 expression (CDLN6+) by central immunohistochemistry testing is required for Phase 1a dose escalation Cohort 5 and higher.
  4. * ≥ 1 measurable lesion as assessed by RECIST v1.1.
  5. * Stable Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
  6. * Adequate organ function.
  1. * 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).
  2. * Palliative radiation treatment or other locoregional therapies ≤ 14 days before the first dose of study drug(s).
  3. * 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.
  4. * Any major surgical procedure ≤ 28 days before the first dose of study drug(s).
  5. * History of prior ≥ Grade 3 cytokine release syndrome (CRS).
  6. * 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).

Contacts and Locations

Study Contact

Study Director
CONTACT
1.877.828.5568
clinicaltrials@beigene.com

Principal Investigator

Study Director
STUDY_DIRECTOR
BeiGene

Study Locations (Sites)

Adventhealth
Celebration, Florida, 34747
United States
Florida Cancer Specialists and Research Institute
Lake Mary, Florida, 32746
United States
Sidney Kimmel Cancer Center
Philadelphia, Pennsylvania, 19107
United States
Avera Cancer Institue
Sioux Falls, South Dakota, 57105
United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109
United States

Collaborators and Investigators

Sponsor: BeiGene

  • Study Director, STUDY_DIRECTOR, BeiGene

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-03-18
Study Completion Date2027-10-30

Study Record Updates

Study Start Date2025-03-18
Study Completion Date2027-10-30

Terms related to this study

Keywords Provided by Researchers

  • Claudin-6
  • CLDN6+
  • advanced or metastatic solid tumor
  • CD3
  • BsAb
  • bispecific antibody
  • CD3-BsAb
  • CLDN

Additional Relevant MeSH Terms

  • Advanced Solid Tumor
  • Metastatic Solid Tumor