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A Study of BGB-B455 for Advanced or Metastatic Solid Tumors

This study is testing a new treatment called BGB-B455 for adults with advanced or metastatic solid tumors (cancers that have spread). BGB-B455 is an immunotherapy that targets a protein called CLDN6, which is found on some tumor cells. The study aims to find the safest and most effective dose of BGB-B455, either alone or with chemotherapy. Researchers will also look at any side effects you might experience. You could be eligible if you have advanced or metastatic solid tumors, especially ovarian, fallopian tube, or primary peritoneal cancer with high CLDN6 levels, and have already received standard treatments or cannot tolerate them. The study is currently unclear on its recruitment status.

Study design
This is an open-label study, meaning both you and your doctor will know which treatment you receive. It has two parts: Phase 1a to find the right dose, and Phase 1b to further test that dose. The study plans to enroll 90 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Your health will be monitored for adverse events (side effects) and serious adverse events for up to 30 days after your last dose of BGB-B455, or until you start a new cancer treatment, for approximately 7 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06803680

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
BeOne Medicines
~90 participants
Updated 2026-08-24 on ClinicalTrials.gov
What's tested:BGB-B455Chemotherapy

At a glance

Recruiting sites
10 of 11 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Phase 1a: Number of participants with adverse events (AEs) and serious adverse events (SAEs)
Measured over 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
+3 more outcomes measured

Conditions

Advanced Solid Tumor
Metastatic Solid Tumor

Explore related trials

Fallopian Tube CarcinomaMalignant Ovarian NeoplasmPrimary Peritoneal CancerSolid NeoplasmCLDN6 Gene

Where it's being run

11 sites across 10 states
New South Wales2
Florida1
Pennsylvania1
South Dakota1
Texas1
Washington1
Beijing Municipality1
Jiangxi1

Study leadership

  • Study Director · STUDY_DIRECTOR · BeOne Medicines

Who to contact

Study Director
[email protected]
1.877.828.5568
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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).

What this trial measures

  • Phase 1a: Number of participants with adverse events (AEs) and serious adverse events (SAEs)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

    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.

  • Phase 1a: Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) of BGB-B455Approximately 1 month

    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.

  • Phase 1a: RDFE of BGB-B455Approximately 1 month

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

  • Phase 1b: Overall Response Rate (ORR)Approximately 18 months

    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.