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Clinical Trial NCT06803680 for Advanced Solid Tumor, Metastatic Solid Tumor is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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A Study of BGB-B455 in Adults With Advanced or Metastatic Solid Tumors Phase 1 90 Dose Escalation
Clinical Trial NCT06803680 is designed to study Treatment for Advanced Solid Tumor, Metastatic Solid Tumor. It is a Phase 1 interventional study that is recruiting, having started on 18 March 2025, with plans to enroll 90 participants. Led by BeiGene, it is expected to complete by 30 October 2027. The latest data from ClinicalTrials.gov was last updated on 4 March 2026.
Brief 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: do...
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 t...Show More
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
Conditions
Advanced Solid TumorMetastatic Solid TumorOther Study IDs
- BGB-B455-101
- 2024-512931-64-00 (EU Study (CTIS) Number)
- CTR20251939 (Registry Identifier) (ChinaDrugTrials)
NCT ID Number
Start Date (Actual)
2025-03-18
Last Update Posted
2026-03-04
Completion Date (Estimated)
2027-10-30
Enrollment (Estimated)
90
Study Type
Interventional
PHASE
Phase 1
Status
Recruiting
Keywords
Claudin-6
CLDN6+
advanced or metastatic solid tumor
CD3
BsAb
bispecific antibody
CD3-BsAb
CLDN
CLDN6+
advanced or metastatic solid tumor
CD3
BsAb
bispecific antibody
CD3-BsAb
CLDN
Primary Purpose
Treatment
Design Allocation
Non-Randomized
Interventional Model
Sequential
Masking
None (Open Label)
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalPhase 1a: Dose Escalation and Safety Expansion Sequential cohorts of increasing dose levels of BGB-B455 will be evaluated as monotherapy. | BGB-B455 Planned doses administered on specified days per protocol. |
ExperimentalPhase 1b: Dose Expansion Recommended 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. | BGB-B455 Planned doses administered on specified days per protocol. Chemotherapy Administered in accordance with relevant local guidelines and/or prescribing information. |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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. | 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 | 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. | Approximately 1 month |
Phase 1a: RDFE of BGB-B455 | RDFE of BGB-B455 will be determined based upon the MTD or MAD. | Approximately 1 month |
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. | Approximately 18 months |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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. | Approximately 18 months |
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. | Approximately 18 months |
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. | Approximately 18 months |
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. | Approximately 18 months |
Phase 1a and 1b: Serum concentrations of BGB-B455 | Approximately 7 months | |
Phase 1a and 1b: Number of participants with anti-drug antibodies (ADAs) to BGB-B455 | Approximately 7 months | |
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. | Approximately 18 months |
Phase 1b: Number of participants with AEs | Number of participants with AEs, including physical examinations, electrocardiograms (ECGs), and laboratory assessments as indicated. | 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 and 1b: Area under the concentration-time curve (AUC) of BGB-B455 | Approximately 4 months | |
Phase 1a and 1b: Maximum observed plasma concentration (Cmax) of BGB-B455 | Approximately 4 months | |
Phase 1a and 1b: Time to reach maximum observed plasma concentration (Tmax) of BGB-B455 | Approximately 4 months | |
Phase 1a and 1b: Trough Concentration (Ctrough) of BGB-B455 | Approximately 7 months | |
Phase 1a and 1b: Apparent clearance (CL) of BGB-B455 | Approximately 4 months | |
Phase 1a and 1b: Volume of distribution (Vd) of BGB-B455 | Approximately 4 months | |
Phase 1a and 1b: Accumulation Ratio of BGB-B455 | Approximately 4 months | |
Phase 1a and 1b: Terminal half-life (t1/2) of BGB-B455 | Approximately 4 months |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
- 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.
- 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.
- 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.
BeiGeneStudy Central Contact
Contact: Study Director, 1.877.828.5568, [email protected]
13 Study Locations in 3 Countries
New South Wales
Blacktown Cancer and Haematology Centre, Blacktown, New South Wales, NSW 2148, Australia
Recruiting
Liverpool Hospital, Liverpool, New South Wales, NSW 2170, Australia
Recruiting
Queensland
Mater Cancer Care Centre, South Brisbane, Queensland, QLD 4101, Australia
Recruiting
Florida
Adventhealth, Celebration, Florida, 34747-4606, United States
Recruiting
Pennsylvania
Sidney Kimmel Cancer Center, Philadelphia, Pennsylvania, 19107-4307, United States
Recruiting
South Dakota
Avera Cancer Institute, Sioux Falls, South Dakota, 57105-2108, United States
Recruiting
Texas
Next Oncology, San Antonio, Texas, 78229-6028, United States
Recruiting
Washington
Fred Hutchinson Cancer Research Center, Seattle, Washington, 98109-4433, United States
Recruiting
Beijing Municipality
Beijing Cancer Hospital, Beijing, Beijing Municipality, 100142, China
Recruiting
Guangdong
Sun Yat Sen University Cancer Center, Guangzhou, Guangdong, 510060, China
Recruiting
Jiangxi
The First Affiliated Hospital of Nanchang University Branch Donghu, Nanchang, Jiangxi, 330006, China
Recruiting
Shanghai Municipality
Fudan University Shanghai Cancer Centerpudong, Shanghai, Shanghai Municipality, 201321, China
Recruiting
Shanxi
Shanxi Provincial Cancer Hospital, Taiyuan, Shanxi, 030013, China
Recruiting