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A Study Investigating the Efficacy and Safety of Ociperlimab and Tislelizumab and BAT1706 Combinations in Patients With Advanced HCC

Sponsor
BeiGene (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT04948697
Collaborator
(none)
90
Enrollment
25
Locations
2
Arms
23.4
Anticipated Duration (Months)
3.6
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a Phase 2, randomized, multicenter, open-label, 2-arm study to investigate the efficacy and safety of ociperlimab in combination with tislelizumab plus BAT1706, and tislelizumab plus BAT1706, as first-line treatment in participants with advanced HCC.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
90 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 2, Randomized, Open-labeled Clinical Study Investigating the Efficacy and Safety of Ociperlimab in Combination With Tislelizumab Plus BAT1706 and of Tislelizumab Plus BAT1706 as First-line Treatment in Patients With Advanced Hepatocellular Carcinoma
Actual Study Start Date :
Aug 20, 2021
Anticipated Primary Completion Date :
Mar 1, 2023
Anticipated Study Completion Date :
Aug 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Arm A: ociperlimab + tislelizumab + BAT1706

tislelizumab 200 mg intravenously once every 3 weeks followed by BAT1706 15 mg/kg intravenously once every 3 weeks followed by ociperlimab 900 mg intravenously once every 3 weeks

Drug: Ociperlimab
900 mg intravenously once every 3 weeks (dosed in 21-day cycles)
Other Names:
  • BGB-A1217

    • Drug: Tislelizumab
    200 mg intravenously once every 3 weeks (dosed in 21-day cycles)
    Other Names:
  • BGB-A317

    • Drug: BAT1706
    15 mg/kg intravenously once every 3 weeks (dosed in 21-day cycles)
    Other Names:
  • Bevacizumab Injection

    		•
    Experimental: Arm B: tislelizumab + BAT1706

    tislelizumab 200 mg intravenously once every 3 weeks followed by BAT1706 15 mg/kg intravenously once every 3 weeks

    Drug: Tislelizumab
    200 mg intravenously once every 3 weeks (dosed in 21-day cycles)
    Other Names:
  • BGB-A317

    • Drug: BAT1706
    15 mg/kg intravenously once every 3 weeks (dosed in 21-day cycles)
    Other Names:
  • Bevacizumab Injection

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Objective Response Rate (ORR) as assessed by the investigator [Time from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months]

      defined as the proportion of participants with a confirmed complete response (CR) or partial response (PR) per RECIST v1.1

    Secondary Outcome Measures

    1. Duration of Response (DOR) as assessed by the investigator [time from the first confirmed objective response until the first documentation of disease progression or death, whichever comes first. assessed up to 24 months]

      DOR is the time from the date of first documentation of a partial response (PR) or better to the date of first documentation of progressive disease (PR or better). DOR will be assessed based on RECIST v1.1.

    2. TIme to Response (TTR) as assessed by the investigator [time from the date of first dose of study drug to the first documentation of response, assessed up to 24 months]

      TTR is defined as the time from the date of first dose administration to the date of first documented partial response (PR) or better by the investigator. TTR will be assessed based on RECIST v1.1.

    3. Disease Control Rate (DCR) as assessed by the investigator [time from the first confirmed objective response until the first documentation of disease progression or death, whichever comes first, assessed up to 24 months]

      DCR is defined as the percentage of participants who achieve complete response (CR), partial response (PR) or durable stable disease (stable disease defined as greater than or equal to (≥) 24 weeks)). The DCR will be assessed based on RECIST v1.1.

    4. Clinical Benefit Rate (CBR) [time from the first confirmed objective response until the first documentation of disease progression or death, whichever comes first, assessed up to 24 months]

      defined as the proportion of participants who achieve complete response (CR), partial response (PR), or durable stable disease (stable disease defined as greater than or equal to (≥) 24 weeks)

    5. PFS as assessed by the investigator [time from the date of the first dose of study drug to the date of first documentation of disease progression or death, whichever occurs first, assessed up to 24 months]

      PFS will be evaluated by the investigator according to RECIST version 1.1. PFS is defined as the time from the date of first dose to the date of first documentation of disease progression or date of death from any cause, whichever occurs first

    6. Overall Survival (OS) [time from the date of the first dose of study drug until the date of death from any cause, assessed up to 24 months]

      measured time from the date of the first dose of study drug until the date of death from any cause

    7. Incidence and severity of adverse events (AEs), [time from the date of the first dose of study drug until the date of death from any cause, assessed up to 24 months]

      severity determined according to National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] Version [v] 5.0, vital signs and clinical laboratory test results

    8. Serum concentrations of ociperlimab at specified timepoints [Through study completion, up to 24 months]

      Collected at time intervals: predose on Day 1 of Cycles 1, 2, 5, 9 and 17. Postdose on Day 1 of Cycles 1 and 5 and Safety Follow-up Visit

    9. Serum concentrations of tislelizumab at specified timepoints [Through study completion, up to 24 months]

      Collected at time intervals: predose on Day 1 of Cycles 1, 2, 5, 9 and 17. Postdose on Day 1 of Cycles 1 and 5 and Safety Follow-up Visit

    10. Serum concentrations of BAT1706 at specified timepoints [Through study completion, up to 24 months]

      Collected at time intervals: predose on Day 1 of Cycles 1,2, 5, 9, and 17. Postdose on Day 1of Cycles 1 and 5 and EOT Visit

    11. Immunogenic Response to ociperlimab [Through study completion, up to 24 months]

      evaluated through detection of antidrug antibodies (ADAs). Time to onset of immunogenic response will be reported Collected at time intervals: predose on Day 1 of Cycles 1, 2, 5, 9 and 17, and at Safety Follow-up Visit

    12. Immunogenic Response to tislelizumab [Through study completion, up to 24 months]

      evaluated through detection of antidrug antibodies (ADAs). Time to onset of immunogenic response will be reported Collected at time intervals: predose on Day 1 of Cycles 1, 2, 5, 9 and 17, and at Safety Follow-up Visit

    13. Immunogenic Response to BAT1706 [Through study completion, up to 24 months]

      evaluated through detection of antidrug antibodies (ADAs). Time to onset of immunogenic response will be reported Collected at time intervals: predose on Day 1 of Cycles 1, 2, 5, 9 and 17, and at EOT Visit

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Criteria:
    Inclusion Criteria:

    1. Histologically confirmed HCC

    2. BCLC Stage C disease, or BCLC Stage B disease that is not amenable to or has progressed after loco-regional therapy, and is not amenable to a curative treatment approach

    3. Tumor tissue required for an evaluable PD-L1 expression result

    4. No prior systemic therapy for HCC

    5. At least 1 measurable lesion as defined per RECIST v1.1

    6. Adequate organ function during screening and before randomization

    Exclusion Criteria:

    1. Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC histology

    2. Prior therapy with antibody or drug specifically targeting T-cell costimulation or checkpoint pathway; prior treatment with bevacizumab or its biosimilars

    3. Prior history of ≥ Grade 2 hepatic encephalopathy

    4. Leptomeningeal disease or uncontrolled, untreated brain metastasis

    5. Active autoimmune diseases or history of autoimmune diseases that may relapse

    6. History of interstitial lung disease, non-infectious pneumonitis or uncontrolled lung diseases including pulmonary fibrosis, acute lung diseases

    7. Infection (including tuberculosis) requiring systemic antibacterial, antifungal, or antiviral therapy within 14 days of randomization

    8. Prior allogeneic stem cell transplantation or organ transplantation

    9. Significant cardiovascular risk factors

    10. Untreated or incompletely treated esophageal or gastric varices with bleeding or high risk of bleeding

    11. History of severe hypersensitivity reactions to other monoclonal antibodies

    12. Administered a live vaccine ≤ 28 days before randomization

    NOTE: Other protocol Inclusion/Exclusion criteria may apply

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Cancer Hospital Chinese Academy of Medical Sciences Beijing Beijing China 100021
    2 Beijing Cancer Hospital Beijing Beijing China 100142
    3 Chongqing University Three Gorges Hospital Chongqing Chongqing China
    4 Fujian Cancer Hospital Fuzhou Fujian China 350014
    5 Mengchao Hepatobiliary Hospital of Fujian Medical University Gulou Fuzhou China
    6 Guangdong Provincial People's Hospital Guangzhou Guangdong China 510080
    7 The First Affiliated Hospital, Sun Yat-sen University Guangzhou Guangdong China
    8 Harbin Medical University Cancer Hospital Harbin Heilongjiang China 150000
    9 Hubei Cancer Hospital Wuhan Hubei China
    10 Hunan Cancer Hospital Changsha Hunan China 410006
    11 The First Hospital of China Medical University Shenyang Liaoning China 110001
    12 Shengjing Hospital of China Medical University Shenyang Liaoning China 110022
    13 Fudan University Zhongshan Hospital Shanghai Shanghai China 200032
    14 West China Hospital Sichuan University Chengdu Sichuan China 610041
    15 Tianjin Medical University Cancer institute & Hospital Tianjin Tianjin China 300070
    16 Tianjin Third Central Hospital Tianjin Tianjin China
    17 The Second Affiliated Hospital of Zhejiang University School of Medicine Hangzhou Zhejiang China 310009
    18 Nanfang Hospital of Southern Medical University Guangdong China
    19 The Second Affiliated Hospital of Nanchang University Jiangxi China
    20 Hwa Mei Hospital, University of Chinese Academy of Sciences Zhejiang China
    21 National Cheng Kung University Hospital Tainan Taiwan 704
    22 Chi Mei Medical Center Tainan Taiwan 710
    23 National Taiwan University Hospital Taipei Taiwan 100
    24 Taipei Veterans General Hospital Taipei Taiwan 112
    25 Chang Gung Medical Foundation (CGMF) - Linkou Branch Taoyuan Taiwan 33305

    Sponsors and Collaborators

    • BeiGene

    Investigators

    • Study Director: Vincent Li, MD, BeiGene, Ltd.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    BeiGene
    ClinicalTrials.gov Identifier:
    NCT04948697
    Other Study ID Numbers:
    • AdvanTIG-206
    First Posted:
    Jul 2, 2021
    Last Update Posted:
    Jul 15, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Carcinoma
    Carcinoma, Hepatocellular
    Bevacizumab

    Study Results

    No Results Posted as of Jul 15, 2022