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

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

Study Overview

• Status: Recruiting
• Conditions: Advanced Solid Tumor; Metastatic Solid Tumor
• Intervention / Treatment: Drug: Chemotherapy; Drug: BGB-B455

Detailed 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 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.

Our company, previously known as BeiGene, is now officially BeOne Medicines. Because some of our older studies were sponsored under the name BeiGene, you may see both names used for this study on this website.

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Study Director; Phone Number: 1.877.828.5568; Email: clinicaltrials@beonemed.com

Study Locations

• Australia
  • New South Wales
    • Blacktown, New South Wales, Australia, NSW 2148
      • Recruiting
      • Blacktown Cancer and Haematology Centre
    • Liverpool, New South Wales, Australia, NSW 2170
      • Recruiting
      • Liverpool Hospital
  • Queensland
    • South Brisbane, Queensland, Australia, QLD 4101
      • Recruiting
      • Mater Cancer Care Centre
• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100142
      • Completed
      • Beijing Cancer Hospital
  • Guangdong
    • Guangzhou, Guangdong, China, 510060
      • Recruiting
      • Sun Yat sen University Cancer Center
  • Jiangxi
    • Nanchang, Jiangxi, China, 330006
      • Recruiting
      • The First Affiliated Hospital of Nanchang University Branch Donghu
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 201321
      • Recruiting
      • Fudan University Shanghai Cancer Centerpudong
  • Shanxi
    • Taiyuan, Shanxi, China, 030013
      • Recruiting
      • Shanxi Provincial Cancer Hospital
• United States
  • Florida
    • Celebration, Florida, United States, 34747-4606
      • Recruiting
      • AdventHealth
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107-4307
      • Recruiting
      • Sidney Kimmel Cancer Center
  • South Dakota
    • Sioux Falls, South Dakota, United States, 57105-2108
      • Recruiting
      • Avera Cancer Institute
  • Texas
    • San Antonio, Texas, United States, 78229-6028
      • Recruiting
      • Next Oncology
  • Washington
    • Seattle, Washington, United States, 98109-4433
      • Recruiting
      • Fred Hutchinson Cancer Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Phase 1a: Dose Escalation and Safety Expansion; Sequential cohorts of increasing dose levels of BGB-B455 will be evaluated as monotherapy.	Drug: BGB-B455; Planned doses administered on specified days per protocol.
Experimental: 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.	Drug: Chemotherapy; Administered in accordance with relevant local guidelines and/or prescribing information.; Drug: BGB-B455; Planned doses administered on specified days per protocol.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Phase 1a: Number of participants with adverse events (AEs) and serious adverse events (SAEs)	Number of participants with AEs and SAEs, including laboratory abnormalities, and AEs that meet protocol-defined dose-limiting toxicity (DLT) criteria or protocol-defined adverse events of special interest (AESI) criteria.	From the first dose of study drug(s) to 30 days after the last dose or initiation of a new anticancer therapy, whichever occurs first; up to approximately 7 months
Phase 1a: Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) of BGB-B455	MTD is defined as the highest dose evaluated for which estimated toxicity rate is the closest to the target toxicity rate. MAD is defined as the highest dose administered if MTD is not reached.	Approximately 1 month
Phase 1a: RDFE of BGB-B455	RDFE of BGB-B455 will be determined based upon the MTD or MAD.	Approximately 1 month
Phase 1b: Overall Response Rate (ORR)	ORR is defined as the percentage of participants with best overall response of complete response (CR) or partial response (PR), as determined from tumor assessments by investigator per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1). CR and PR must be confirmed by repeat assessments.	Approximately 18 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Phase 1a: ORR	ORR is defined as the percentage of participants with best overall response of CR or PR, as determined from tumor assessments by investigator per RECIST v1.1. CR and PR must be confirmed by repeat assessments.	Approximately 18 months
Phase 1a and 1b: Duration of Response (DOR)	DOR is defined as the time from the first confirmed objective response to documented disease progression or death, whichever occurs first, as determined from tumor assessments by investigator per RECIST v1.1.	Approximately 18 months
Phase 1a and 1b: Disease Control Rate (DCR)	DCR is defined as the percentage of participants who achieve CR, PR, or stable disease, as determined from tumor assessments by investigator per RECIST v1.1.	Approximately 18 months
Phase 1a and 1b: Time to Response (TTR)	TTR is defined as the time from the date of the first administration of study drug to the first confirmed response, as determined from tumor assessments by investigator per RECIST v1.1.	Approximately 18 months
Phase 1a and 1b: Serum concentrations of BGB-B455		Approximately 7 months
Phase 1b: Progression-Free Survival (PFS)	PFS is defined as the time from the date of the first administration of study drug to the date of the first documentation of disease progression or death, whichever occurs first, as determined from tumor assessments by investigator per RECIST v1.1.	Approximately 18 months
Phase 1b: Number of participants with AEs	Number of participants with AEs, including physical examinations, electrocardiograms (ECGs), and laboratory assessments as indicated.	From the first dose of study drug(s) to 30 days after the last dose or initiation of a new anticancer therapy, whichever occurs first; up to approximately 7 months
Phase 1a and 1b: Area under the concentration-time curve (AUC) of BGB-B455		Approximately 4 months
Phase 1a and 1b: Maximum observed plasma concentration (Cmax) of BGB-B455		Approximately 4 months
Phase 1a and 1b: Time to reach maximum observed plasma concentration (Tmax) of BGB-B455		Approximately 4 months
Phase 1a and 1b: Trough Concentration (Ctrough) of BGB-B455		Approximately 7 months
Phase 1a and 1b: Apparent clearance (CL) of BGB-B455		Approximately 4 months
Phase 1a and 1b: Volume of distribution (Vd) of BGB-B455		Approximately 4 months
Phase 1a and 1b: Accumulation Ratio of BGB-B455		Approximately 4 months
Phase 1a and 1b: Terminal half-life (t1/2) of BGB-B455		Approximately 4 months

Collaborators and Investigators

• Sponsor: BeOne Medicines
• Investigators: Study Director: Study Director, BeOne Medicines

Study record dates

Study Major Dates

• Study Start (Actual): March 18, 2025
• Primary Completion (Estimated): April 29, 2028
• Study Completion (Estimated): April 29, 2028

Study Registration Dates

• First Submitted: January 27, 2025
• First Submitted That Met QC Criteria: January 27, 2025
• First Posted (Actual): January 31, 2025

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: May 20, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: bispecific antibody; CD3; Claudin-6; CLDN6+; advanced or metastatic solid tumor; BsAb; CD3-BsAb; CLDN
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Neoplastic Processes; Pathological Conditions, Signs and Symptoms; Neoplasm Metastasis; Therapeutics; Drug Therapy
• Other Study ID Numbers: BGB-B455-101; 2024-512931-64-00 (Ctis); CTR20251939 (Registry Identifier: ChinaDrugTrials)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

BeOne shares data on completed studies responsibly and provides qualified scientific and medical researchers access to data and supporting documentation for clinical trials in dossiers for medicines and indications after submission and approval in the United States, China, and Europe. Clinical trials supporting subsequent local approvals, new indications, or combination products are eligible for sharing once corresponding regulatory approvals are achieved.

BeOne shares data only when permitted by applicable data privacy and security laws and regulations, when it is feasible to do so without compromising the privacy of study participants, and other considerations.

Qualified researchers with appropriate competencies who are engaged in novel scientific research may submit a request for participant-level data with a research proposal for BeOne review. Research teams must include a biostatistician and sign a Data Sharing Agreement prior to receiving access to clinical trial data.

• IPD Sharing Time Frame: See plan description
• IPD Sharing Access Criteria: See plan description
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No