RecruitingPhase 1

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

United States, Australia, China90 participantsStarted 2025-03-18

Plain-language 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 BGB-B455? The study has two parts: * Phase 1a: dose escalation and safety expansion * Phase 1b: dose expansion

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 f…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: 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

Timeframe: Approximately 1 month

Phase 1a: RDFE of BGB-B455

Timeframe: Approximately 1 month

Phase 1b: Overall Response Rate (ORR)

Timeframe: Approximately 18 months

Trial details

NCT IDNCT06803680

SponsorBeOne Medicines

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2028-04-29

Contact for this trial

Study Director

1.877.828.5568 clinicaltrials@beonemed.com

View on ClinicalTrials.gov More Advanced Solid Tumor trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

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

Timeframe: 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

Timeframe: Approximately 1 month

Phase 1a: RDFE of BGB-B455

Timeframe: Approximately 1 month

Phase 1b: Overall Response Rate (ORR)

Timeframe: Approximately 18 months