Solid TumorsPhase 1NCT05644626
Safety, Pharmacokinetics and Antitumor Activity of BGB-B167 Alone and in Combination With Tislelizumab in Participants With Solid Tumors in Chinese Participants
A Phase 1 study testing BGB-B167 and Tislelizumab in people with Solid Tumors, run by BeiGene.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumors
- What is being tested?
- BGB-B167 and Tislelizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Mar 2024to Aug 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
About this study
Official title: 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
- Conditions
- Solid Tumors
- Being tested
- BGB-B167, Tislelizumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BGB-B167Drug
Intravenous administration
TislelizumabDrug
Also called BGB-A317
Intravenous administration
| Study group | Role | What they receive |
|---|---|---|
| Phase 1a: Dose Escalation | Experimental | Part A: Increasing dose levels of BGB-B167 monotherapy; Part B: Increasing dose levels of BGB-B167 in combination with tislelizumab (BGB-A317) Receives: Drug: BGB-B167; Drug: Tislelizumab |
| Phase 1b: Dose Expansion | Experimental | BGB-B167 alone or in combination with tislelizumab (BGB-A317) Receives: Drug: BGB-B167; Drug: Tislelizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase 1a: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Measured: Up to Approximately 30 months
Phase 1a: Number of Participants Experiencing AEs Meeting Protocol-defined Dose-limiting Toxicity (DLT) Criteria
Measured: Up to Approximately 24 months
Phase 1a: Maximum Tolerated Dose (MTD) of BGB-B167
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%.
Measured: Approximately 30 months
Phase 1a: Recommended Phase 2 doses (RP2Ds)
RP2Ds of BGB-B167 alone or in combination with tislelizumab will be determined based on a biologically effective dose
Measured: Approximately 24 months
Phase 1b: Objective Response Rate (ORR) as determined by investigators per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
ORR is defined as the proportion of participants who had confirmed complete response (CR) or partial response (PR).
Measured: Up to Approximately 30 months
Secondary outcomes (14)
Phase 1a: ORR
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.
Measured: Up to Approximately 30 months
Phase 1a and Phase 1b: Duration of Response (DOR) as determined by investigators per RECIST v1.1.
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.
Measured: Up to Approximately 30 months
Phase 1a and Phase 1b: Disease Control Rate (DCR) as determined by investigators per RECIST v1.1.
DCR is defined as the proportion of participants with best overall response (BOR) of confirmed CR, PR, or stable disease
Measured: Up to Approximately 30 months
Phase 1a and Phase 1b: Clinical Benefit Rate (CBR) as determined by investigators per RECIST v1.1.
CBR is defined as the proportion of participants with BOR of confirmed CR, PR, or stable disease lasting ≥ 24 weeks.
Measured: Up to Approximately 30 months
Phase 1b: Progression Free Survival (PFS) as determined by investigators per RECIST v1.1.
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.
Measured: Up to Approximately 30 months
Phase 1a and Phase 1b: Maximum Serum Concentration (Cmax) of BGB-B167
Measured: Up to Approximately 30 months
Phase 1a and Phase 1b: Minimum Observed Plasma Concentration (Cmin) of BGB-B167
Measured: Up to Approximately 30 months
Phase 1a and Phase 1b: Time to Cmax (Tmax) of BGB-B167
Measured: Up to Approximately 30 months
Phase 1a: Terminal half-life (t1/2) of BGB-B167
Measured: Up to Approximately 30 months
Phase 1a: Area Under the Plasma Concentration-time curve (AUC0-7d) of BGB-B167
Measured: Up to Approximately 30 months
Phase 1a: Clearance (CL) BGB-B167
Measured: Up to Approximately 30 months
Phase 1a: Volume of Distribution at Steady State (Vss) of BGB-B167
Measured: Up to Approximately 30 months
Phase 1a and Phase 1b: Number of Participants with Anti-Drug Antibodies (ADAs)
Measured: Up to Approximately 30 months
Phase 1b: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Measured: Up to Approximately 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2022
- Study startMar 2024 (estimated)
- Primary completionMar 2025 (estimated)
- Study completionAug 2025 (estimated)
Why it stopped: Sponsor determined the data was no longer needed.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorsStudies of the same condition, open and under way.
- More trials run by BeiGeneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- BeiGene
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05644626
- Sponsor's protocol ID
- BGB-A317-B167-102
- Status last verified
- Nov 2023
- First submitted
- 1 Dec 2022
- Last updated
- 29 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05644626
- Acronym / sponsor ID
- BGB-A317-B167-102
- Conditions
- Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Sponsor determined the data was no longer needed.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- BeiGeneIndustry (pharma, biotech, devices)
- Study start
- Mar 2024 (estimated)
- Primary completion
- Mar 2025 (estimated)
- Study completion
- Aug 2025 (estimated)
- First posted
- 9 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phase 1a: Dose Escalation | Experimental | Drug: BGB-B167, Drug: TislelizumabPart A: Increasing dose levels of BGB-B167 monotherapy; Part B: Increasing dose levels of BGB-B167 in combination with tislelizumab (BGB-A317) |
| Phase 1b: Dose Expansion | Experimental | Drug: BGB-B167, Drug: TislelizumabBGB-B167 alone or in combination with tislelizumab (BGB-A317) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BGB-B167Intravenous administration | Drug | Phase 1a: Dose Escalation, Phase 1b: Dose Expansion |
| TislelizumabAlso: BGB-A317Intravenous administration | Drug | Phase 1a: Dose Escalation, Phase 1b: Dose Expansion |
Primary outcome
Phase 1a: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: 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
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%.
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
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).
14 secondary outcomes
Phase 1a: ORR
Time frame: 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
Phase 1a and Phase 1b: Disease Control Rate (DCR) as determined by investigators per RECIST v1.1.
Time frame: 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
Phase 1b: Progression Free Survival (PFS) as determined by investigators per RECIST v1.1.
Time frame: Up to Approximately 30 months
Phase 1a and Phase 1b: Maximum Serum Concentration (Cmax) of BGB-B167
Time frame: 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
Phase 1a and Phase 1b: Time to Cmax (Tmax) of BGB-B167
Time frame: Up to Approximately 30 months
Phase 1a: Terminal half-life (t1/2) of BGB-B167
Time frame: 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
Phase 1a: Clearance (CL) BGB-B167
Time frame: Up to Approximately 30 months
Phase 1a: Volume of Distribution at Steady State (Vss) of BGB-B167
Time frame: 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
Phase 1b: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Up to Approximately 30 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BGB-B167 and Tislelizumab in people with Solid Tumors, run by BeiGene.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 29 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase 1a: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) (time frame: Up to Approximately 30 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2023.