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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 : September 23, 2022
Sponsor:
Information provided by (Responsible Party):
BeiGene

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.

Condition or disease Intervention/treatment Phase
Solid Tumor Drug: BGB-B167 Drug: Tislelizumab Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 254 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : August 25, 2022
Estimated Primary Completion Date : February 5, 2025
Estimated Study Completion Date : August 5, 2025

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)
Drug: BGB-B167
Intravenous administration

Drug: Tislelizumab
Intravenous administration
Other Name: BGB-A317

Experimental: Phase 1b: Dose Expansion
BGB-B167 alone or in combination with tislelizumab (BGB-A317)
Drug: BGB-B167
Intravenous administration

Drug: Tislelizumab
Intravenous administration
Other Name: BGB-A317




Primary Outcome Measures :
  1. Phase 1a: Number of Participants Experiencing Adverse Events (AEs) [ Time Frame: Up to approximately 3 years ]
  2. Phase 1a: Number of Participants Experiencing Serious Adverse Events (SAEs) [ Time Frame: Up to approximately 3 years ]
  3. Phase 1a: Number of Participants Experiencing AEs Meeting Protocol-defined Dose-limiting Toxicity (DLT) Criteria [ Time Frame: Up to approximately 3 years ]
  4. 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%

  5. 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

  6. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. Phase 1a and 1b: Serum Concentration of Tislelizumab [ Time Frame: Up to approximately 3 years ]
  7. Phase 1a and 1b: Maximum observed serum concentration (Cmax) of BGB-B167 [ Time Frame: Up to approximately 3 years ]
  8. Phase 1a and 1b: Minimum observed serum concentration (Cmin) of BGB-B167 [ Time Frame: Up to approximately 3 years ]
  9. Phase 1a and 1b: Time to reach maximum observed serum concentration (Tmax) of BGB-B167 [ Time Frame: Up to approximately 3 years ]
  10. Phase 1a and 1b: Elimination half life (t1/2) of BGB-B167 [ Time Frame: Up to approximately 3 years ]
  11. 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 ]
  12. Phase 1a and 1b: Total body clearance (CL) of BGB-B167 [ Time Frame: Up to approximately 3 years ]
  13. Phase 1a and 1b: Volume of distribution at steady state (Vss) of BGB-B167 [ Time Frame: Up to approximately 3 years ]
  14. Phase 1b: Number of Participants with AEs or SAEs [ Time Frame: Up to approximately 3 years ]
  15. Phase 1a and 1b: Number of Participants with Antidrug Antibodies (ADAs) [ Time Frame: Up to approximately 3 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05494762


Contacts
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Contact: BeiGene 1-877-828-5568 clinicaltrials@beigene.com

Locations
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United States, California
City of Hope National Medical Center Not yet recruiting
Duarte, California, United States, 91010
United States, Connecticut
Yale Cancer Center Not yet recruiting
New Haven, Connecticut, United States, 06510
United States, Tennessee
Tennessee Oncology Not yet recruiting
Nashville, Tennessee, United States, 37203
Australia, New South Wales
Blacktown Hospital Not yet recruiting
Blacktown, New South Wales, Australia, 2148
Australia, South Australia
Ashford Cancer Centre Research Recruiting
Kurralta Park, South Australia, Australia, 5125
Australia, Victoria
Monash Health Recruiting
Clayton, Victoria, Australia, 3168
Peter MacCallum Cancer Centre Recruiting
Melbourne, Victoria, Australia, 3000
Alfred Hospital Recruiting
Melbourne, Victoria, Australia, 3004
Sponsors and Collaborators
BeiGene
Investigators
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Study Director: Study Director BeiGene
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Responsible Party: BeiGene
ClinicalTrials.gov Identifier: NCT05494762    
Other Study ID Numbers: BGB-A317-B167-101
First Posted: August 10, 2022    Key Record Dates
Last Update Posted: September 23, 2022
Last Verified: September 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasms