BGB-B455: Planned doses administered on specified days per protocol.
Chemotherapy: Administered in accordance with relevant local guidelines and/or prescribing information.
Study 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?
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.
Primary outcome measure(s)
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-B455 — Approximately 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-B455 — Approximately 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.
Trial sites (11)
Facility
City
Region
Status
Adventhealth
Celebration
Florida
Recruiting
Sidney Kimmel Cancer Center
Philadelphia
Pennsylvania
Recruiting
Avera Cancer Institute
Sioux Falls
South Dakota
Recruiting
Next Oncology
San Antonio
Texas
Recruiting
Fred Hutchinson Cancer Research Center
Seattle
Washington
Recruiting
Blacktown Cancer and Haematology Centre
Blacktown
New South Wales
Recruiting
Liverpool Hospital
Liverpool
New South Wales
Recruiting
Beijing Cancer Hospital
Beijing
Beijing Municipality
Completed
The First Affiliated Hospital of Nanchang University Branch Donghu
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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