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

Study of Ociperlimab (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 : February 14, 2023
Sponsor:
Information provided by (Responsible Party):
BeiGene

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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 (known as Ociperlimab) in combination with tislelizumab in participants with advanced solid tumors in phase 1.

Primary objective of Phase 1b is to assess overall response rate (ORR) determined by Investigator per RECIST v1.1 for patients in each dose- expansion cohort


Condition or disease Intervention/treatment Phase
Locally Advanced and Metastatic Solid Tumors Drug: Ociperlimab Drug: Tislelizumab Drug: Pemetrexed Drug: Paclitaxel Drug: Nab paclitaxel Drug: Carboplatin Drug: Cisplatin Drug: Etoposide Drug: 5fluorouracil Drug: Oxaliplatin Drug: Capecitabine Phase 1

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 542 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 : May 2024
Estimated Study Completion Date : October 2024
Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Phase 1

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

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

 Drug: Ociperlimab
Administered as an intravenous (IV) injection

Drug: Tislelizumab
Administered as an IV injection
Experimental: Phase 1b Cohort 1
Participants with metastatic squamous NSCLC will receive ociperlamib + tislelizumab + paclitaxel/nab-paclitaxel + Carbo once every 3 weeks (Q3W) for 4 to 6 cycles (21 days each) followed by ociperlimab + tislelizumab Q3W)
 Drug: Ociperlimab
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
Participants with metastatic squamous NSCLC will receive ociperlimab + tislelizumab + pemetrexed + Cis/Carbo Q3W for 4 to 6 cycles (21 days each) followed by ociperlamib+tislelizumab Q3W)
 Drug: Ociperlimab
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
Participants with metastatic NSCLC (PD-L1 positive, [TC] ≥ 1%) will be treated with ociperlimab + tislelizumab
 Drug: Ociperlimab
Administered as an intravenous (IV) injection

Drug: Tislelizumab
Administered as an IV injection
Experimental: Phase 1b Cohort 4
Patients with extensive stage SCLC will be treated with ociperlimab + tislelizumab + etoposide + Cis/Carbo Q3W for up to 6 to 8 cycles followed by ociperlamib+tislelizumab Q3W
 Drug: Ociperlimab
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 patients will be treated with ociperlimab plus tislelizumab
 Drug: Ociperlimab
Administered as an intravenous (IV) injection

Drug: Tislelizumab
Administered as an IV injection
Experimental: Phase1b Cohort 6
Patients with metastatic ESCC will be treated with ociperlimab + tislelizumab + cisplatin + 5-fluorouracil /paclitaxel Q3W for 6 cycles followed by ociperlamib+tislelizumab Q3W
 Drug: Ociperlimab
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: Cisplatin
Administered in accordance with local guidelines , prescribing information/summary of product

Drug: 5fluorouracil
Administered in accordance with local guidelines , prescribing information/summary of product
Experimental: Phase1b Cohort 7
Patients with metastatic EAC will be treated with ociperlimab + tislelizumab + cisplatin + 5-fluorouracil or paclitaxel Q3W for 6 cycles followed by ociperlamib+tislelizumab Q3W
 Drug: Ociperlimab
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: Cisplatin
Administered in accordance with local guidelines , prescribing information/summary of product

Drug: 5fluorouracil
Administered in accordance with local guidelines , prescribing information/summary of product
Experimental: Phase1b Cohort 8
Patients with recurrent or metastatic HNSCC (PD-L1 positive, vCPS≥ 1%) will be treated with ociperlimab + tislelizumab Q3W
 Drug: Ociperlimab
Administered as an intravenous (IV) injection

Drug: Tislelizumab
Administered as an IV injection
Experimental: Phase1b Cohort 9
Patients with metastatic G/GEJ carcinoma will be treated with ociperlimab + tislelizumab + [oxalipatin + capecitabine] or [cisplatin + 5-fluorouracil] Q3W for 6 cycles followed by ociperlamib+tislelizumab + capecitabine Q3W
 Drug: Ociperlimab
Administered as an intravenous (IV) injection

Drug: Tislelizumab
Administered as an IV injection

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

Drug: 5fluorouracil
Administered in accordance with local guidelines , prescribing information/summary of product

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

Drug: Capecitabine
Administered in accordance with local guidelines , prescribing information/summary of product
Experimental: Phase 1b Cohort10
Patients with metastatic NSCLC (PD-L1 positive, [TC] ≥ 1%) will be treated with tislelizumab in combination with ociperlimab 450mg, 900mg or 1800mg Q3W.
 Drug: Ociperlimab
Administered as an intravenous (IV) injection

Drug: Tislelizumab
Administered as an IV injection


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Phase 1 Dose Escalation - 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 ociperlimab in combination with tislelizumab [ Time Frame: Up to 1.5 years ]
  4. Phase 1b Dose Confirmation - Anti-tumor activity of ociperlimab 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 ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.


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

Key Inclusion Criteria:

Phase 1 Key Inclusion Criteria

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

Phase 1b Key Inclusion Criteria

  1. Signed informed consent form (ICF) and able to comply with study requirements.
  2. Age ≥ 18 years (or the legal age of consent) at the time the ICF is signed.

  3. Histologically or cytologically confirmed tumor types in the following disease cohorts:

    Cohort 1: stage IV squamous NSCLC Cohort 2: stage IV non-squamous NSCLC Cohort 3: stage IV squamous or non-squamous NSCLC with PD-L1 positive. Cohort 4: extensive-stage SCLC Cohort 5: stage IIIB, IIIC or IV NSCLC Cohort 6: stage IV ESCC Cohort 7: stage IV EAC Cohort 8: recurrent or metastatic HNSCC incurable by local therapies Cohort 9: stage IV G/GEJ adenocarcinoma. Cohort 10: stage IV squamous or non-squamous NSCLC with PD-L1 positive.

  4. ECOG Performance Status ≤ 1
  5. Adequate organ function
  6. Willing to use highly effective method of birth control

Phase 1 Key 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.

Phase 1b Key Exclusion Criteria:

  1. Patients with any prior therapy for recurrent/metastatic disease.
  2. Non-squamous NSCLC patients with sensitizing epidermal growth factor receptor (EGFR) mutation, anaplastic lymphoma kinase (ALK) fusion, and c-ros oncogene 1 (ROS1) fusion.
  3. Gastric cancer patients with squamous or with positive HER2 expression.
  4. Prior therapy with any drug specifically targeting T-cell co-stimulation or checkpoint pathways. (anti-PD(L)1 exception for Cohort 5).
  5. Active leptomeningeal disease or uncontrolled brain metastasis.
  6. Active autoimmune diseases or history of autoimmune diseases that may relapse.
  7. 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).
  8. Concurrent participation in another therapeutic clinical study.

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

Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Layout table for location contacts
Contact: BeiGene 1-877-828-5568 clinicaltrials@beigene.com

Locations
Show Show 75 study locations
Sponsors and Collaborators
BeiGene
Investigators
Layout table for investigator information
Study Director: Study Director BeiGene
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: BeiGene
ClinicalTrials.gov Identifier: NCT04047862    
Other Study ID Numbers: BGB-900-105
AdvanTIG-105 ( Other Identifier: BeiGene )
First Posted: August 7, 2019    Key Record Dates
Last Update Posted: February 14, 2023
Last Verified: February 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Layout table for additional information
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
Ociperlimab
Additional relevant MeSH terms:
Layout table for MeSH terms
Neoplasms
Paclitaxel
Etoposide
Albumin-Bound Paclitaxel
Carboplatin
Fluorouracil
Capecitabine
Oxaliplatin
Pemetrexed
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
 Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors