We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Safety, Pharmacokinetics, and Antitumor Activity of BGB-B167 Alone and in Combination With Tislelizumab (BGB-A317) in Participants With Advanced Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05494762
Recruitment Status : Recruiting
First Posted : August 10, 2022
Last Update Posted : November 21, 2022
Sponsor:
Information provided by (Responsible Party):
BeiGene

Tracking Information
First Submitted Date  ICMJE August 8, 2022
First Posted Date  ICMJE August 10, 2022
Last Update Posted Date November 21, 2022
Actual Study Start Date  ICMJE August 25, 2022
Estimated Primary Completion Date February 5, 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 22, 2022)
  • 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
Original Primary Outcome Measures  ICMJE
 (submitted: August 8, 2022)
  • 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 MTD or maximum administered 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
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 8, 2022)
  • Phase 1a: 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 RECIST v1.1
  • Phase 1a and 1b: Duration of Response (DOR) [ Time Frame: Up to approximately 3 years ]
    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
  • Phase 1a and 1b: Disease Control Rate (DCR) [ Time Frame: Up to approximately 3 years ]
    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
  • Phase 1a and 1b: Clinical Benefit Rate (CBR) [ Time Frame: Up to approximately 3 years ]
    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
  • Phase 1b: Progression-free Survival (PFS) [ Time Frame: Up to approximately 3 years ]
    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
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety, Pharmacokinetics, and Antitumor Activity of BGB-B167 Alone and in Combination With Tislelizumab (BGB-A317) in Participants With Advanced Solid Tumors
Official Title  ICMJE 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
Brief 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Solid Tumor
Intervention  ICMJE
  • Drug: BGB-B167
    Intravenous administration
  • Drug: Tislelizumab
    Intravenous administration
    Other Name: BGB-A317
Study Arms  ICMJE
  • 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)
    Interventions:
    • Drug: BGB-B167
    • Drug: Tislelizumab
  • Experimental: Phase 1b: Dose Expansion
    BGB-B167 alone or in combination with tislelizumab (BGB-A317)
    Interventions:
    • Drug: BGB-B167
    • Drug: Tislelizumab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 8, 2022)
254
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 5, 2025
Estimated Primary Completion Date February 5, 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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)

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
  • Women who are pregnant or are breastfeeding

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: BeiGene 1-877-828-5568 clinicaltrials@beigene.com
Listed Location Countries  ICMJE Australia,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05494762
Other Study ID Numbers  ICMJE BGB-A317-B167-101
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Current Responsible Party BeiGene
Original Responsible Party Same as current
Current Study Sponsor  ICMJE BeiGene
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Study Director BeiGene
PRS Account BeiGene
Verification Date November 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP