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Advanced Solid TumorPhase 1NCT06803680

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

A Phase 1 study testing BGB-B455 and Chemotherapy in people with Advanced Solid Tumor and Metastatic Solid Tumor, run by BeOne Medicines at 11 sites in 3 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Solid Tumor, Metastatic Solid Tumor
What is being tested?
BGB-B455 and Chemotherapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
11 sitesin 3 countries
Study dates
18 Mar 2025to 29 Apr 2028
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

11 sites in 3 countries. Contact the study team or a site near you to ask about taking part.

Study Director contact

1.877.828.5568

clinicaltrials@beonemed.com

11 sites in 3 countries

United States5 sites, 5 recruiting

  • Adventhealth

    Celebration, Florida, 34747-4606

    Recruiting

  • Sidney Kimmel Cancer Center

    Philadelphia, Pennsylvania, 19107-4307

    Recruiting

  • Next Oncology

    San Antonio, Texas, 78229-6028

    Recruiting

  • Fred Hutchinson Cancer Research Center

    Seattle, Washington, 98109-4433

    Recruiting

  • Avera Cancer Institute

    Sioux Falls, South Dakota, 57105-2108

    Recruiting

Other trials in United States

China4 sites, 3 recruiting

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality, 100142

    Completed

  • The First Affiliated Hospital of Nanchang University Branch Donghu

    Nanchang, Jiangxi, 330006

    Recruiting

  • Fudan University Shanghai Cancer Centerpudong

    Shanghai, Shanghai Municipality, 201321

    Recruiting

  • Shanxi Provincial Cancer Hospital

    Taiyuan, Shanxi, 030013

    Recruiting

Other trials in China

Australia2 sites, 2 recruiting

  • Blacktown Cancer and Haematology Centre

    Blacktown, New South Wales, NSW 2148

    Recruiting

  • Liverpool Hospital

    Liverpool, New South Wales, NSW 2170

    Recruiting

Other trials in Australia

About this study

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

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
Read the 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.

Being tested
BGB-B455, Chemotherapy
Keywords
Claudin-6, CLDN6+, advanced or metastatic solid tumor, CD3, BsAb, bispecific antibody, CD3-BsAb, CLDN
Medical subject headings
Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BGB-B455Drug

    Planned doses administered on specified days per protocol.

  • ChemotherapyDrug

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

Study groups in NCT06803680
Study groupRoleWhat they receive
Phase 1a: Dose Escalation and Safety ExpansionExperimentalSequential cohorts of increasing dose levels of BGB-B455 will be evaluated as monotherapy.
Receives: Drug: BGB-B455
Phase 1b: Dose ExpansionExperimentalRecommended 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.
Receives: Drug: BGB-B455; Drug: Chemotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 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

  2. 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.

    Measured: Approximately 1 month

  3. Phase 1a: RDFE of BGB-B455

    RDFE of BGB-B455 will be determined based upon the MTD or MAD.

    Measured: Approximately 1 month

  4. 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.

    Measured: Approximately 18 months

Secondary outcomes (15)

  1. 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.

    Measured: Approximately 18 months

  2. 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.

    Measured: Approximately 18 months

  3. 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.

    Measured: Approximately 18 months

  4. 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.

    Measured: Approximately 18 months

  5. Phase 1a and 1b: Serum concentrations of BGB-B455

    Measured: Approximately 7 months

  6. 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.

    Measured: Approximately 18 months

  7. Phase 1b: Number of participants with AEs

    Number of participants with AEs, including physical examinations, electrocardiograms (ECGs), and laboratory assessments as indicated.

    Measured: 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

  8. Phase 1a and 1b: Area under the concentration-time curve (AUC) of BGB-B455

    Measured: Approximately 4 months

  9. Phase 1a and 1b: Maximum observed plasma concentration (Cmax) of BGB-B455

    Measured: Approximately 4 months

  10. Phase 1a and 1b: Time to reach maximum observed plasma concentration (Tmax) of BGB-B455

    Measured: Approximately 4 months

  11. Phase 1a and 1b: Trough Concentration (Ctrough) of BGB-B455

    Measured: Approximately 7 months

  12. Phase 1a and 1b: Apparent clearance (CL) of BGB-B455

    Measured: Approximately 4 months

  13. Phase 1a and 1b: Volume of distribution (Vd) of BGB-B455

    Measured: Approximately 4 months

  14. Phase 1a and 1b: Accumulation Ratio of BGB-B455

    Measured: Approximately 4 months

  15. Phase 1a and 1b: Terminal half-life (t1/2) of BGB-B455

    Measured: Approximately 4 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Jan 2025
  2. Study start18 Mar 2025
  3. Primary completion29 Apr 2028 (estimated)
  4. Study completion29 Apr 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
90 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06803680
Sponsor's protocol ID
BGB-B455-101
Other IDs
2024-512931-64-00, CTR20251939
Status last verified
May 2026
First submitted
27 Jan 2025
Last updated
24 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing BGB-B455 and Chemotherapy in people with Advanced Solid Tumor and Metastatic Solid Tumor, run by BeOne Medicines at 11 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 24 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in United States, China, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Study Director (1.877.828.5568, clinicaltrials@beonemed.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Phase 1a: Number of participants with adverse events (AEs) and serious adverse events (SAEs) (time frame: 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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06803680.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2026.

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