- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05644626
Safety, Pharmacokinetics and Antitumor Activity of BGB-B167 Alone and in Combination With Tislelizumab in Participants With Solid Tumors in Chinese Participants
November 27, 2023 updated by: BeiGene
A Phase 1a/1b Study Investigating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of BGB-B167, Alone and in Combination With Tislelizumab in Chinese Patients With Selected Advanced or Metastatic Solid Tumors
This study will evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary antitumor activity of BGB-B167 monotherapy and in combination with tislelizumab (BGB-A317) in participants with select advanced solid tumors in Chinese participants
Study Overview
Study Type
Interventional
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: BeiGene
- Phone Number: 1-877-828-5568
- Email: clinicaltrials@beigene.com
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Participants with histologically or cytologically confirmed unresectable locally advanced or metastatic solid tumors previously treated with standard systemic therapy or for whom treatment is not available, not tolerated, or refused, or not expected to provide significant clinical benefit or be tolerated in the medical judgement of the investigator
- Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1
- Adequate organ function as indicated by laboratory values during screening or ≤ 7 days before the first dose of study drug(s)
- Women of childbearing potential must be willing to use a highly effective method of birth control for the duration of the study
- Nonsterile men must be willing to use highly effective method of birth control for the duration of the study
Exclusion Criteria:
- Active leptomeningeal disease or uncontrolled, untreated brain metastasis
- Active autoimmune diseases or history of autoimmune diseases that may relapse
- Any malignancy ≤ 3 years before the first dose of study drug(s) except for the specific cancer under investigation in this study and any locally recurring cancer that has been treated with curative intent
- History of severe hypersensitivity reactions to other monoclonal antibody products or their excipients
- Untreated chronic hepatitis B or chronic hepatitis B virus (HBV) carriers
- Known history of HIV infection.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Phase 1a: Dose Escalation
Part A: Increasing dose levels of BGB-B167 monotherapy; Part B: Increasing dose levels of BGB-B167 in combination with tislelizumab (BGB-A317)
|
Intravenous administration
Intravenous administration
Other Names:
|
Experimental: Phase 1b: Dose Expansion
BGB-B167 alone or in combination with tislelizumab (BGB-A317)
|
Intravenous administration
Intravenous administration
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Phase 1a: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time Frame: Up to Approximately 30 months
|
Up to Approximately 30 months
|
|
Phase 1a: Number of Participants Experiencing AEs Meeting Protocol-defined Dose-limiting Toxicity (DLT) Criteria
Time Frame: Up to Approximately 24 months
|
Up to Approximately 24 months
|
|
Phase 1a: Maximum Tolerated Dose (MTD) of BGB-B167
Time Frame: Approximately 30 months
|
The maximum tolerated dose (MTD) is defined as the highest tolerated dose for which the estimated toxicity rate is closest to the target toxicity rate of 30%.
|
Approximately 30 months
|
Phase 1a: Recommended Phase 2 doses (RP2Ds)
Time Frame: Approximately 24 months
|
RP2Ds of BGB-B167 alone or in combination with tislelizumab will be determined based on a biologically effective dose
|
Approximately 24 months
|
Phase 1b: Objective Response Rate (ORR) as determined by investigators per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Time Frame: Up to Approximately 30 months
|
ORR is defined as the proportion of participants who had confirmed complete response (CR) or partial response (PR).
|
Up to Approximately 30 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Phase 1a: ORR
Time Frame: Up to Approximately 30 months
|
ORR is defined as the proportion of participants who had confirmed complete response (CR) or partial response (PR) as determined by investigators per RECIST v1.1.
|
Up to Approximately 30 months
|
Phase 1a and Phase 1b: Duration of Response (DOR) as determined by investigators per RECIST v1.1.
Time Frame: Up to Approximately 30 months
|
DOR is defined as the time from the first determination of a confirmed objective response until the first documentation of progression or death due to any cause, whichever occurs first.
|
Up to Approximately 30 months
|
Phase 1a and Phase 1b: Disease Control Rate (DCR) as determined by investigators per RECIST v1.1.
Time Frame: Up to Approximately 30 months
|
DCR is defined as the proportion of participants with best overall response (BOR) of confirmed CR, PR, or stable disease
|
Up to Approximately 30 months
|
Phase 1a and Phase 1b: Clinical Benefit Rate (CBR) as determined by investigators per RECIST v1.1.
Time Frame: Up to Approximately 30 months
|
CBR is defined as the proportion of participants with BOR of confirmed CR, PR, or stable disease lasting ≥ 24 weeks.
|
Up to Approximately 30 months
|
Phase 1b: Progression Free Survival (PFS) as determined by investigators per RECIST v1.1.
Time Frame: Up to Approximately 30 months
|
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 due to any cause, whichever occurs first.
|
Up to Approximately 30 months
|
Phase 1a and Phase 1b: Maximum Serum Concentration (Cmax) of BGB-B167
Time Frame: Up to Approximately 30 months
|
Up to Approximately 30 months
|
|
Phase 1a and Phase 1b: Minimum Observed Plasma Concentration (Cmin) of BGB-B167
Time Frame: Up to Approximately 30 months
|
Up to Approximately 30 months
|
|
Phase 1a and Phase 1b: Time to Cmax (Tmax) of BGB-B167
Time Frame: Up to Approximately 30 months
|
Up to Approximately 30 months
|
|
Phase 1a: Terminal half-life (t1/2) of BGB-B167
Time Frame: Up to Approximately 30 months
|
Up to Approximately 30 months
|
|
Phase 1a: Area Under the Plasma Concentration-time curve (AUC0-7d) of BGB-B167
Time Frame: Up to Approximately 30 months
|
Up to Approximately 30 months
|
|
Phase 1a: Clearance (CL) BGB-B167
Time Frame: Up to Approximately 30 months
|
Up to Approximately 30 months
|
|
Phase 1a: Volume of Distribution at Steady State (Vss) of BGB-B167
Time Frame: Up to Approximately 30 months
|
Up to Approximately 30 months
|
|
Phase 1a and Phase 1b: Number of Participants with Anti-Drug Antibodies (ADAs)
Time Frame: Up to Approximately 30 months
|
Up to Approximately 30 months
|
|
Phase 1b: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time Frame: Up to Approximately 30 months
|
Up to Approximately 30 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
March 1, 2024
Primary Completion (Estimated)
March 1, 2025
Study Completion (Estimated)
August 1, 2025
Study Registration Dates
First Submitted
December 1, 2022
First Submitted That Met QC Criteria
December 1, 2022
First Posted (Actual)
December 9, 2022
Study Record Updates
Last Update Posted (Actual)
November 29, 2023
Last Update Submitted That Met QC Criteria
November 27, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BGB-A317-B167-102
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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