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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 : November 4, 2019
Sponsor:
Information provided by (Responsible Party):
BeiGene

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.

Condition or disease Intervention/treatment Phase
Metastatic Solid Tumors Drug: BGB-A1217 Drug: Tislelizumab Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 39 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : August 26, 2019
Estimated Primary Completion Date : April 5, 2021
Estimated Study Completion Date : April 5, 2021

Arm Intervention/treatment
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.
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




Primary Outcome Measures :
  1. 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 ]
  2. Phase 1 Dose Escalation - Recommended Phase Ib dose (RP2D) of BGB-A1217 in combination with tislelizumab [ Time Frame: Up to 1.5 years ]
  3. 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 ]

Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. Progression free survival [ Time Frame: Up to 3 years ]
    Progression free survival will be determined from investigator derived tumor assessments per RECIST 1.1.

  4. Immunogenicity [ Time Frame: Up to 3 years ]
    Immunogenicity as assessed by the presence of anti-drug antibodies



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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:

  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.

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): NCT04047862


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

Locations
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Australia, New South Wales
Chris O'Brien Lifehouse Not yet recruiting
Camperdown, New South Wales, Australia, 2050
Australia, Victoria
Monash Hospital Not yet recruiting
Clayton, Victoria, Australia, 3168
Australia, Western Australia
Linear Clinical Research Recruiting
Perth, Western Australia, Australia, 6009
Sponsors and Collaborators
BeiGene
Investigators
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Principal Investigator: Tarek Meniawy, MD Linear Clinical Research

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Responsible Party: BeiGene
ClinicalTrials.gov Identifier: NCT04047862     History of Changes
Other Study ID Numbers: BGB-900-105
First Posted: August 7, 2019    Key Record Dates
Last Update Posted: November 4, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by BeiGene:
BGB-A1217
Anti-TIGIT antibody
Tislelizumab
anti-PD-1
Additional relevant MeSH terms:
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Neoplasms
Antibodies
Immunologic Factors
Physiological Effects of Drugs