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New drug BGB-B455 targets tough tumors in early trial

NCT ID NCT06803680

Disease control Sponsor: BeOne Medicines Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 25, 2026 · Updated 6 times

Summary

This early-phase trial tests a new drug called BGB-B455 in about 90 people with advanced or metastatic solid tumors that have a specific protein (CLDN6). The main goals are to find a safe dose and see what side effects occur. The study has two parts: first finding the right dose, then checking how well the drug works against the tumors.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
BGB-B455
What this could lead to
If it works, this could point toward a new treatment option for people with advanced solid tumors that have the CLDN6 protein.
What could go wrong
This is a very early Phase 1 trial with only 90 participants, so it is not yet known if BGB-B455 is safe or effective. Many early-stage drugs do not move forward.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 90 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2025

Expected to finish

Apr 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

fallopian tube cancer metastatic malignant neoplasm neoplasm Neoplasm Metastasis ovarian carcinoma primary peritoneal carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Advanced solid tumor Metastatic solid tumor

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    10 sites in 3 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Adventhealth

    RECRUITING

    Celebration, Florida, 34747-4606, United States

  • Avera Cancer Institute

    RECRUITING

    Sioux Falls, South Dakota, 57105-2108, United States

  • Beijing Cancer Hospital

    COMPLETED

    Beijing, Beijing Municipality, 100142, China

  • Blacktown Cancer and Haematology Centre

    RECRUITING

    Blacktown, New South Wales, NSW 2148, Australia

  • Fred Hutchinson Cancer Research Center

    RECRUITING

    Seattle, Washington, 98109-4433, United States

  • Fudan University Shanghai Cancer Centerpudong

    RECRUITING

    Shanghai, Shanghai Municipality, 201321, China

  • Liverpool Hospital

    RECRUITING

    Liverpool, New South Wales, NSW 2170, Australia

  • Next Oncology

    RECRUITING

    San Antonio, Texas, 78229-6028, United States

  • Shanxi Provincial Cancer Hospital

    RECRUITING

    Taiyuan, Shanxi, 030013, China

  • Sidney Kimmel Cancer Center

    RECRUITING

    Philadelphia, Pennsylvania, 19107-4307, United States

  • The First Affiliated Hospital of Nanchang University Branch Donghu

    RECRUITING

    Nanchang, Jiangxi, 330006, China

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