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Study of BGB-A1217 in Combination With Tislelizumab in 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: NCT04047862
Recruitment Status : Recruiting
First Posted : August 7, 2019
Last Update Posted : November 4, 2020
Sponsor:
Information provided by (Responsible Party):
BeiGene

Brief Summary:
The primary objectives of this study are: to assess the safety and tolerability, to determine the maximum tolerated dose (MTD) or maximum administered dose (MAD) and to determine the recommended Phase 2 dose (RP2D) of BGB-A1217 in combination with tislelizumab in participants with advanced solid tumors.

Condition or disease Intervention/treatment Phase
Locally Advanced and Metastatic Solid Tumors Drug: BGB-A1217 Drug: Tislelizumab Drug: Pemetrexed Drug: Paclitaxel Drug: Nab paclitaxel Drug: Carboplatin Drug: Cisplatin Drug: Etoposide Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 234 participants
Allocation: Non-Randomized
Intervention Model: Parallel 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 : July 2023
Estimated Study Completion Date : August 2023

Arm Intervention/treatment
Experimental: Phase 1

Cycle 1 (28 Days): A flat dose of BGB-A1217 as a single agent on Day 1. In the first cycle, 200 mg tislelizumab will be administered on Day 8.

If BGB-A1217 is tolerated in Cycle 1, participants will receive tislelizumab + BGB-A1217 sequentially on Day 29 and every 21 days for up to 8 months.

Drug: BGB-A1217
Administered as an intravenous (IV) injection

Drug: Tislelizumab
Administered as an IV injection

Experimental: Phase 1b Cohort 1
First line participants with metastatic squamous NSCLC will receive BGB-A1217 + tislelizumab + paclitaxel/nab-paclitaxel + Carbo once every 3 weeks (Q3W) for 4 to 6 cycles (21 days each)
Drug: BGB-A1217
Administered as an intravenous (IV) injection

Drug: Tislelizumab
Administered as an IV injection

Drug: Paclitaxel
Administered in accordance with local guidelines , prescribing information/summary of product

Drug: Nab paclitaxel
Administered in accordance with local guidelines , prescribing information/summary of product

Drug: Carboplatin
Administered in accordance with local guidelines , prescribing information/summary of product

Experimental: Phase 1b Cohort 2
First line participants with metastatic squamous NSCLC will receive BGB-A1217 + tislelizumab + pemetrexed + Cis/Carbo Q3W for 4 to 6 cycles (21 days each)
Drug: BGB-A1217
Administered as an intravenous (IV) injection

Drug: Tislelizumab
Administered as an IV injection

Drug: Pemetrexed
Administered in accordance with local guidelines, prescribing information/summary of product

Drug: Carboplatin
Administered in accordance with local guidelines , prescribing information/summary of product

Drug: Cisplatin
Administered in accordance with local guidelines , prescribing information/summary of product

Experimental: Phase 1b Cohort 3
First-line participants with metastatic NSCLC (PD-L1 positive, [TPS] ≥ 1%) will be treated with BGB-A1217 + tislelizumab for up to 6 to 8 months
Drug: BGB-A1217
Administered as an intravenous (IV) injection

Drug: Tislelizumab
Administered as an IV injection

Experimental: Phase 1b Cohort 4
First-line participants with extensive SCLC will be treated with BGB-A1217 + tislelizumab + etoposide + Cis/Carbo Q3W for up to 6 to 8 months
Drug: BGB-A1217
Administered as an intravenous (IV) injection

Drug: Tislelizumab
Administered as an IV injection

Drug: Carboplatin
Administered in accordance with local guidelines , prescribing information/summary of product

Drug: Cisplatin
Administered in accordance with local guidelines , prescribing information/summary of product

Drug: Etoposide
Administered in accordance with local guidelines , prescribing information/summary of product

Experimental: Phase 1b Cohort 5
Checkpoint inhibitor (CPI)-experienced NSCLC participants who have received 1 or 2 prior therapies including an anti-PD-(L)1 in the most recent line of treatment and progressed after a best response of CR, PR, or SD will be treated with BGB-A1217 plus tislelizumab for up to 6 to 8 months
Drug: BGB-A1217
Administered as an intravenous (IV) injection

Drug: Tislelizumab
Administered as an IV injection




Primary Outcome Measures :
  1. Number of participants experiencing Dose-Limiting Toxicities (DLTs) According to National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI-CTCAE v.5.0) [ Time Frame: Up to 28 Days in Cycle 1 ]
  2. Phase 1 Dose Escalation - Number of participants experiencing Serious Adverse Events (SAEs) [ Time Frame: Up to 1.5 years ]
  3. Phase 1 Dose Escalation - Recommended Phase Ib dose (RP2D) of BGB-A1217 in combination with tislelizumab [ Time Frame: Up to 1.5 years ]
  4. 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 as assessed by the presence of anti-drug antibodies [ Time Frame: Up to 3 years ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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

Key Inclusion Criteria:

  1. 1. Has Eastern Cooperative Oncology Group (ECOG) Performance Status ≤1;
  2. ≥ 1 measurable lesion per RECIST v1.1;
  3. Has adequate organ function. Phase 1
  4. 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.

    Phase 1b

  5. Newly diagnosed histologically or cytologically confirmed stage IV NSCLC for cohort 1 and 2 (squamous for cohort 1 and non-squamous for cohort2);
  6. Newly diagnosed histologically or cytologically confirmed stage IV NSCLC with PD-L1 testing result positive (TPS≥1%) for cohort 3;
  7. Newly diagnosed histologically or cytologically confirmed extensive-stage SCLC for cohort 4;
  8. Histologically or cytologically confirmed NSCLC previously treated with standard systemic therapy with an anti-PD-(L)1 therapy in most recent line of treatment for cohort 5.

Key Exclusion Criteria:

  1. 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.
  6. For patients with non-squamous NSCLC in Phase 1b, participants with sensitizing epidermal growth factor receptor (EGFR) mutation, anaplastic lymphoma kinase (ALK) fusion, and c-ros oncogene 1 (ROS1) fusion are excluded.

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): NCT04047862


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

Locations
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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    
Other Study ID Numbers: BGB-900-105
First Posted: August 7, 2019    Key Record Dates
Last Update Posted: November 4, 2020
Last Verified: November 2020
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
Keywords provided by BeiGene:
BGB-A1217
Anti-TIGIT antibody
Tislelizumab
anti-PD-1
Additional relevant MeSH terms:
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Neoplasms
Paclitaxel
Etoposide
Albumin-Bound Paclitaxel
Carboplatin
Pemetrexed
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors