Solid TumorPhase 1NCT05494762
Safety, Pharmacokinetics, and Antitumor Activity of BGB-B167 Alone and in Combination With Tislelizumab (BGB-A317) in Participants With Advanced Solid Tumors
A Phase 1 study testing BGB-B167 and Tislelizumab in people with Solid Tumor, run by BeiGene at 8 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor
- 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
- 55 participants
- Where
- 8 sitesin 2 countries
- Study dates
- 25 Aug 2022to 24 Feb 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
- Age 18 or older
- 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)
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
- Women who are pregnant or are breastfeeding
- NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Trial locations and contacts
8 sites in 2 countries.
8 sites in 2 countries
Australia5 sites
Blacktown Cancer and Haematology Centre
Blacktown, New South Wales, 2148
Monash Health
Clayton, Victoria, 3168
Icon Cancer Centre Kurralta Park
Kurralta Park, South Australia, 5037
Peter Maccallum Cancer Centre
Melbourne, Victoria, 3000
The Alfred Hospital
Melbourne, Victoria, 3004
United States3 sites
City of Hope National Medical Center
Duarte, California, 91010-3012
Tennessee Oncology, Pllc Nashville
Nashville, Tennessee, 37203-1619
Yale University, Yale Cancer Center
New Haven, Connecticut, 06520-8028
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 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.
- Conditions
- Solid Tumor
- 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 Experiencing Adverse Events (AEs)
Measured: Up to approximately 3 years
Phase 1a: Number of Participants Experiencing Serious Adverse Events (SAEs)
Measured: Up to approximately 3 years
Phase 1a: Number of Participants Experiencing AEs Meeting Protocol-defined Dose-limiting Toxicity (DLT) Criteria
Measured: Up to approximately 3 years
Phase 1a: Maximum tolerated dose (MTD)
MTD is defined as the highest tolerated dose with the target toxicity rate of 30%
Measured: Up to approximately 3 years
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: Up to 90 days after the last dose of study drug(s); up to approximately 3 years
Phase 1b: Objective Response Rate (ORR)
ORR is defined as the percentage of participants who had confirmed complete response (CR) or partial response (PR) as determined by investigators per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Measured: Up to approximately 3 years
Secondary outcomes (15)
Phase 1a: ORR
ORR is defined as the percentage of participants who had confirmed complete response (CR) or partial response (PR) as determined by investigators per RECIST v1.1
Measured: Up to approximately 3 years
Phase 1a and 1b: Duration of Response (DOR)
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, as determined by investigators per RECIST v1.1
Measured: Up to approximately 3 years
Phase 1a and 1b: Disease Control Rate (DCR)
DCR is defined as the percentage of participants with best overall response (BOR) of confirmed CR, PR, or stable disease, as determined by investigators per RECIST v1.1
Measured: Up to approximately 3 years
Phase 1a and 1b: Clinical Benefit Rate (CBR)
CBR is defined as the percentage of patients with best overall response of confirmed CR, PR, or stable disease lasting ≥ 24 weeks, as determined by investigators per RECIST v1.1
Measured: Up to approximately 3 years
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 due to any cause, whichever occurs first, as determined by investigators per RECIST v1.1
Measured: Up to approximately 3 years
Phase 1a and 1b: Serum Concentration of Tislelizumab
Measured: Up to approximately 3 years
Phase 1a and 1b: Maximum observed serum concentration (Cmax) of BGB-B167
Measured: Up to approximately 3 years
Phase 1a and 1b: Minimum observed serum concentration (Cmin) of BGB-B167
Measured: Up to approximately 3 years
Phase 1a and 1b: Time to reach maximum observed serum concentration (Tmax) of BGB-B167
Measured: Up to approximately 3 years
Phase 1a and 1b: Elimination half life (t1/2) of BGB-B167
Measured: Up to approximately 3 years
Phase 1a and 1b: Area under the concentration-time curve in 1 dosing interval (AUCtau) of BGB-B167
Measured: Up to approximately 3 years
Phase 1a and 1b: Total body clearance (CL) of BGB-B167
Measured: Up to approximately 3 years
Phase 1a and 1b: Volume of distribution at steady state (Vss) of BGB-B167
Measured: Up to approximately 3 years
Phase 1b: Number of Participants with AEs or SAEs
Measured: Up to approximately 3 years
Phase 1a and 1b: Number of Participants with Antidrug Antibodies (ADAs)
Measured: Up to approximately 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2022
- Study start25 Aug 2022
- Primary completion24 Feb 2025
- Study completion24 Feb 2025
Why it stopped: Sponsor decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies 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
- Sequential
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- BeiGene
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, BeiGene
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05494762
- Sponsor's protocol ID
- BGB-A317-B167-101
- Status last verified
- Apr 2025
- First submitted
- 8 Aug 2022
- Last updated
- 1 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: BeiGene shares data on completed studies responsibly and provides qualified scientific and medical researchers access to data and supporting documentation for clinical trials in dossiers for medicines and indications after submission and approval in the United States, China, and Europe. Clinical trials supporting subsequent local approvals, new indications, or combination products are eligible for sharing once corresponding regulatory approvals are achieved. BeiGene shares data only when permitted by applicable data privacy and security laws and regulations, when it is feasible to do so without compromising the privacy of study participants, and other considerations. Qualified researchers with appropriate competencies who are engaged in novel scientific research may submit a request for participant-level data with a research proposal for BeiGene review. Research teams must include a biostatistician and sign a Data Sharing Agreement prior to receiving access to clinical trial data.
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2025. 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 Patients With Selected Advanced or Metastatic Solid Tumors
- ClinicalTrials.gov ID
- NCT05494762
- Acronym / sponsor ID
- BGB-A317-B167-101
- Conditions
- Solid Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor decision
- Enrolment
- 55 participants (actual)
- Lead sponsor
- BeiGeneIndustry (pharma, biotech, devices)
- Study start
- 25 Aug 2022 (actual)
- Primary completion
- 24 Feb 2025 (actual)
- Study completion
- 24 Feb 2025 (actual)
- First posted
- 10 Aug 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- 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 (4 listed)
- Age 18 or older
- 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)
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
- Women who are pregnant or are breastfeeding
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 Experiencing Adverse Events (AEs)
Time frame: Up to approximately 3 years
Phase 1a: Number of Participants Experiencing Serious Adverse Events (SAEs)
Time frame: Up to approximately 3 years
Phase 1a: Number of Participants Experiencing AEs Meeting Protocol-defined Dose-limiting Toxicity (DLT) Criteria
Time frame: Up to approximately 3 years
Phase 1a: Maximum tolerated dose (MTD)
Time frame: Up to approximately 3 years
MTD is defined as the highest tolerated dose with the target toxicity rate of 30%
Phase 1a: Recommended Phase 2 doses (RP2Ds)
Time frame: Up to 90 days after the last dose of study drug(s); up to approximately 3 years
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)
Time frame: Up to approximately 3 years
ORR is defined as the percentage of participants who had confirmed complete response (CR) or partial response (PR) as determined by investigators per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
15 secondary outcomes
Phase 1a: ORR
Time frame: Up to approximately 3 years
Phase 1a and 1b: Duration of Response (DOR)
Time frame: Up to approximately 3 years
Phase 1a and 1b: Disease Control Rate (DCR)
Time frame: Up to approximately 3 years
Phase 1a and 1b: Clinical Benefit Rate (CBR)
Time frame: Up to approximately 3 years
Phase 1b: Progression-free Survival (PFS)
Time frame: Up to approximately 3 years
Phase 1a and 1b: Serum Concentration of Tislelizumab
Time frame: Up to approximately 3 years
Phase 1a and 1b: Maximum observed serum concentration (Cmax) of BGB-B167
Time frame: Up to approximately 3 years
Phase 1a and 1b: Minimum observed serum concentration (Cmin) of BGB-B167
Time frame: Up to approximately 3 years
Phase 1a and 1b: Time to reach maximum observed serum concentration (Tmax) of BGB-B167
Time frame: Up to approximately 3 years
Phase 1a and 1b: Elimination half life (t1/2) of BGB-B167
Time frame: Up to approximately 3 years
Phase 1a and 1b: Area under the concentration-time curve in 1 dosing interval (AUCtau) of BGB-B167
Time frame: Up to approximately 3 years
Phase 1a and 1b: Total body clearance (CL) of BGB-B167
Time frame: Up to approximately 3 years
Phase 1a and 1b: Volume of distribution at steady state (Vss) of BGB-B167
Time frame: Up to approximately 3 years
Phase 1b: Number of Participants with AEs or SAEs
Time frame: Up to approximately 3 years
Phase 1a and 1b: Number of Participants with Antidrug Antibodies (ADAs)
Time frame: Up to approximately 3 years
Results and safety
The study was stopped early (reason given: Sponsor decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2025.
- Individual participant dataSharing planned: Yes. BeiGene shares data on completed studies responsibly and provides qualified scientific and medical researchers access to data and supporting documentation for clinical trials in dossiers for medicines and indications after submission and approval in the United States, China, and Europe. Clinical trials supporting subsequent local approvals, new indications, or combination products are eligible for sharing once corresponding regulatory approvals are achieved. BeiGene shares data only when permitted by applicable data privacy and security laws and regulations, when it is feasible to do so without compromising the privacy of study participants, and other considerations. Qualified researchers with appropriate competencies who are engaged in novel scientific research may submit a request for participant-level data with a research proposal for BeiGene review. Research teams must include a biostatistician and sign a Data Sharing Agreement prior to receiving access to clinical trial data.
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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.
Study Director study director
BeiGene
8 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BGB-B167 and Tislelizumab in people with Solid Tumor, run by BeiGene at 8 sites in 2 countries.
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 4 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: stopped early, as of the sponsor's last update on 1 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Australia, United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 stopped early (reason given: Sponsor decision). Results are not available in the source record.
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 Experiencing Adverse Events (AEs) (time frame: Up to approximately 3 years). The study lists 6 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 1 May 2025.