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Study of BGB-A1217 in Combination With Tislelizumab in Advanced Solid Tumors

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ClinicalTrials.gov Identifier: NCT04047862
Recruitment Status : Recruiting
First Posted : August 7, 2019
Last Update Posted : September 26, 2019
Sponsor:
Information provided by (Responsible Party):
BeiGene

Tracking Information
First Submitted Date  ICMJE August 1, 2019
First Posted Date  ICMJE August 7, 2019
Last Update Posted Date September 26, 2019
Actual Study Start Date  ICMJE August 26, 2019
Estimated Primary Completion Date April 5, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 6, 2019)
  • Phase 1 Dose Escalation - Safety and tolerability of BGB-A1217 in combination with tislelizumab using Common Terminology Criteria for Adverse Events (CTCAE v.5.0) in patients with advanced solid tumors. [ Time Frame: Up to 1.5 years ]
  • Phase 1 Dose Escalation - Recommended Phase Ib dose (RP2D) of BGB-A1217 in combination with tislelizumab [ Time Frame: Up to 1.5 years ]
  • Phase 1b Dose Confirmation - Anti-tumor activity of BGB-1217 in combination with tislelizumab in patients with select advanced solid tumors, in terms of objective response rate (ORR) as assessed by the Investigators using RECIST v. 1.1. [ Time Frame: Up to 1.5 years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT04047862 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 6, 2019)
  • Duration of response (DOR) [ Time Frame: Up to 3 years ]
    Duration of response (DOR) will be determined from investigator derived tumor assessments per RECIST v. 1.1.
  • Disease control rate (DCR) [ Time Frame: Up to 3 years ]
    Disease control rate (DCR) will be determined from investigator derived tumor assessments per RECIST v. 1.1.
  • Progression free survival [ Time Frame: Up to 3 years ]
    Progression free survival will be determined from investigator derived tumor assessments per RECIST 1.1.
  • Immunogenicity [ Time Frame: Up to 3 years ]
    Immunogenicity as assessed by the presence of anti-drug antibodies
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 Study of BGB-A1217 in Combination With Tislelizumab in Advanced Solid Tumors
Official Title  ICMJE Phase 1/1b Study Investigating Safety, Tolerability, PK and Antitumor Activity of Anti-TIGIT Monoclonal Antibody BGB-A1217 in Combination With Anti-PD-1 Monoclonal Antibody Tislelizumab in Patients With Advanced Solid Tumors
Brief Summary BGB-A1217 is a humanized, IgG1 monoclonal antibody against TIGIT. Tislelizumab is a humanized, IgG4-variant monoclonal antibody against PD-1. This study tests the safety and anti-tumor effect of BGB-A1217 in combination with tislelizumab in patients with advanced solid tumors.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Metastatic Solid Tumors
Intervention  ICMJE
  • Drug: BGB-A1217
    Dose escalation of BGB-A1217 in combination with tislelizumab in patients with advanced solid tumors
  • Drug: Tislelizumab
    Dose escalation of BGB-A1217 in combination with tislelizumab in patients with advanced solid tumors
Study Arms  ICMJE Experimental: Phase 1
A modified 3+3 scheme will be used for sequential cohorts of approximately 5 increasing dose levels of BGB-A1217, evaluated in combination with 200 mg of tislelizumab, to determine the MTD or MAD, RP2D, safety, PK, and other key endpoints.
Interventions:
  • Drug: BGB-A1217
  • 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 6, 2019)
39
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 5, 2021
Estimated Primary Completion Date April 5, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Patients with histologically or cytologically confirmed advanced, metastatic, unresectable solid tumors who have previously received standard systemic therapy or for which treatment is not available, not tolerated or refused.
  2. Has Eastern Cooperative Oncology Group (ECOG) Performance Status ≤1.
  3. Has adequate organ function.

Exclusion Criteria:

  1. Active brain or leptomeningeal metastasis.
  2. Active autoimmune diseases or history of autoimmune diseases that may relapse.
  3. With severe chronic or active infections requiring systemic antibacterial, antifungal or antiviral therapy, including tuberculosis infection, etc. (antiviral therapy is permitted for patients with hepatocellular carcinoma).
  4. Concurrent participation in another therapeutic clinical trial.
  5. Received prior therapies targeting TIGIT.
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: Philippa Whiting BSc 1-877-828-5568 clinicaltrials@beigene.com
Listed Location Countries  ICMJE Australia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04047862
Other Study ID Numbers  ICMJE BGB-900-105
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party BeiGene
Study Sponsor  ICMJE BeiGene
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Tarek Meniawy Linear Clinical Research
PRS Account BeiGene
Verification Date September 2019

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