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Study of the Safety, Pharmacokinetics and Antitumor Activities of BGB-A317 in Subjects With Advanced Tumors

This study is currently recruiting participants.
Verified February 2017 by BeiGene
Sponsor:
ClinicalTrials.gov Identifier:
NCT02407990
First Posted: April 3, 2015
Last Update Posted: February 23, 2017
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.
Information provided by (Responsible Party):
BeiGene
  Purpose
This study will evaluate the safety, tolerability, pharmacokinetic profile and treatment effect of a new drug known as BGB-A317 in patients with advanced tumors.

Condition Intervention Phase
Advanced Cancer Biological: BGB-A317 Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1A/1B, Open Label, Multiple Dose, Dose Escalation and Expansion Study to Investigate the Safety, Pharmacokinetics and Antitumor Activities of the Anti-PD-1 Monoclonal Antibody BGB-A317 in Subjects With Advanced Tumors

Further study details as provided by BeiGene:

Primary Outcome Measures:
  • Number of participants with adverse events [ Time Frame: From first dose to within 30 days of last dose of BGB-A317, up to 2 years and 1 month ]

Secondary Outcome Measures:
  • Area under the plasma concentration-time curve (AUC) [ Time Frame: During first 4 months ]
  • Maximum plasma concentration (Cmax) [ Time Frame: During first 4 months ]
  • Time to reach maximum plasma concentration (Tmax) [ Time Frame: During first 4 months ]
  • Terminal elimination half-life (t1/2) [ Time Frame: During first 4 months ]
  • Disease assessment by CT/MRI scan [ Time Frame: Performed at an expected average of 10 weeks during treatment period (up to 2 years) and within 30 days of last dose of BGB-A317 during follow-up period ]
  • Anti-BGB-A317 antibody [ Time Frame: Performed at an expected average of 6 weeks during treatment period (up to 2 years) and within 30 days of last dose of BGB-A317 during follow-up period ]

Estimated Enrollment: 450
Study Start Date: June 2015
Estimated Study Completion Date: March 2018
Estimated Primary Completion Date: August 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BGB-A317 Biological: BGB-A317

In the dose escalation part, the dose levels will be escalated following a modified 3+3 dose escalation scheme.

In the dose expansion part, patients will be assigned to different groups based on their tumor type.


  Eligibility

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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subjects must have a histologically or cytologically confirmed advanced or metastatic tumor for which no effective standard therapy is available.
  2. Subjects with previously treated brain metastasis (es) that is asymptomatic or radiographically/clinically stable and not requiring steroids medications for 4 weeks prior to enrollment are permitted.
  3. Subjects must have archival tumor tissues or agree to a tumor biopsy for analysis of predictive biomarkers such as PD-L1. (Fresh tumor biopsies are strongly recommended at baseline for biomarker analysis in subjects with readily accessible tumor lesions and who consent to the biopsies.)
  4. Subjects must have measurable disease as defined per RECIST Version 1.1.
  5. Male or female and ≥18 years of age on day of signing informed consent.
  6. Eastern Cooperative Oncology Group (ECOG) performance status of ≤1.
  7. Subjects must have adequate organ function as indicated by the following laboratory values.

    • Absolute neutrophil count (ANC) ≥1,500 /mL
    • Platelets ≥100,000 / mL
    • Hemoglobin ≥9 g/dL or ≥5.6 mmol/L- without qualifications
    • Serum creatinine ≤1.5 X upper limit of normal (ULN)
    • Serum total bilirubin ≤ 1.5 X ULN
    • AST (SGOT) and ALT (SGPT) ≤ 2.5 X ULN OR ≤ 5 X ULN for patients with liver metastases
    • International Normalized Ratio (INR) or Prothrombin Time (PT) ≤1.5 X ULN
    • Activated Partial Thromboplastin Time (aPTT) ≤1.5 X ULN
  8. Subjects have voluntarily agreed to participate by giving written informed consent.
  9. Female subjects are eligible to enter and participate in the study if they

    • Non childbearing potential (i.e., physiologically incapable of becoming pregnant), including any female who

      • Has had a hysterectomy.
      • Has had a bilateral oophorectomy (ovariectomy).
      • Has had a bilateral tubal ligation.
      • Is post menopausal (total cessation of menses for ≥1 year).
    • Childbearing potential, has a negative serum pregnancy test at screening (within 7 days of the first investigational product administration), and uses adequate contraception before study entry and throughout the study until 90 days after the last investigational product administration. Adequate contraception, when used consistently and in accordance with both the product label and the instructions of the physician, are defined as follows:

      • Vasectomized partner who is sterile prior to the female subject's entry and is the sole sexual partner for that female.
      • Any intrauterine device with a documented failure rate of less than 1% per year.
      • Double barrier contraception defined as condom with spermicidal jelly, foam, suppository, or film; OR diaphragm with spermicide; OR male condom and diaphragm.
      • Not be breast feeding.
  10. Male subjects are eligible to enter and participate in the study if they are vasectomized or agree to the use of contraception during the study treatment period and for at least 180 days after the last dose of study drug

Exclusion Criteria:

  1. History of severe hypersensitivity reactions to other mAbs.
  2. Prior malignancy active within the previous 2 years except for tumor for which a patient is enrolled in the study, and locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer or carcinoma in situ of the cervix or breast.
  3. Prior therapies targeting PD-1 or PD-L1.
  4. Subjects who fail to meet enrollment criteria for other PD-1 or PD-L1 trials solely due to low or negative predictive biomarkers.
  5. Subjects with active autoimmune diseases or history of autoimmune diseases should be excluded.
  6. Subjects should be excluded if they have a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration.
  7. Has history of interstitial lung disease or non-infectious pneumonitis except for those induced by radiation therapies..
  8. Known history of Human Immunodeficiency Virus;
  9. Active infection requiring therapy, positive tests for Hepatitis B surface antigen or Hepatitis C ribonucleic acid (RNA);
  10. Underlying medical conditions that, in the Investigator's opinion, will make the administration of study drug hazardous or obscure the interpretation of toxicity determination or adverse events;
  11. Prior chemotherapy, radiotherapy, immunotherapy or any investigational therapies used to control cancer must have been completed at least 4 weeks or at least 5 half-lives (whichever is shorter) before study drug administration, and all adverse events have either returned to baseline or stabilized.
  12. Use of any vaccines against infectious diseases (e.g., influenza, varicella, etc.) within 4 weeks (28 days) of initiation of study therapy and 60 days after the last administration of the study medication.
  Contacts and Locations
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): NCT02407990


Contacts
Contact: Xuemei Tan, MD clinicaltrials@beigene.com

Locations
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
United States, Texas
Oncology Consultants, P.A. Recruiting
Houston, Texas, United States, 77024-2545
Australia, New South Wales
Chris O'Brien Lifehouse Recruiting
Camperdown, New South Wales, Australia, 2050
Prince of Wales Hospital Recruiting
Sydney, New South Wales, Australia
Australia, Queensland
Tasman Oncology Research Ltd Recruiting
Southport, Queensland, Australia, 4216
Princess Alexandra Hospital Recruiting
Woolloongabba, Queensland, Australia, 4102
Australia, South Australia
Royal Adelaide Hospital Recruiting
Adelaide, South Australia, Australia
The Queen Elizabeth Hospital Recruiting
Woodville South, South Australia, Australia
Australia, Victoria
Monash Health Recruiting
Clayton, Victoria, Australia
Peter MacCallum Cancer Centre Recruiting
East Melbourne, Victoria, Australia
Austin Health Hospital Recruiting
Heidelberg, Victoria, Australia
Cabrini Hospital Recruiting
Malvern, Victoria, Australia, 3144
Nucleus Network Recruiting
Melbourne, Victoria, Australia, 3004
Royal Melbourne Hospital Recruiting
Melbourne, Victoria, Australia
Australia, Western Australia
Linear Clinical Research/Sir Charles Gairdner Hospital Recruiting
Nedlands, Western Australia, Australia
Korea, Republic of
Seoul National University Bundang Hospital Recruiting
Seongnam, Kyeonggi-do, Korea, Republic of, 13620
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of, 3080
Asan Medical Center Recruiting
Seoul, Korea, Republic of, 5505
New Zealand
Auckland City Hospital Recruiting
Grafton, New Zealand, 1023
Waikato Recruiting
Hamilton, New Zealand, 3204
Wellington Hospital Recruiting
Wellington, New Zealand, 6022
Taiwan
Chang Gung Memorial Hospital, Chiayi Recruiting
Chiayi, Taiwan, 61363
Kaohsiung Chang Gung Memorial Hospital Recruiting
Kaohsiung, Taiwan, 83301
National Cheng Kung University Hospital Recruiting
Tainan, Taiwan, 704
Taipei Veterans General Hospital Recruiting
Taipei, Taiwan, 11217
National Taiwan University Hospital Recruiting
Taipei, Taiwan
Linkou Chang Gung Memorial Hospital Recruiting
Taoyuan, Taiwan, 33305
Sponsors and Collaborators
BeiGene
Investigators
Study Director: Xuemei Tan, MD BeiGene
  More Information

Responsible Party: BeiGene
ClinicalTrials.gov Identifier: NCT02407990     History of Changes
Other Study ID Numbers: BGB-A317_Study_001
First Submitted: March 26, 2015
First Posted: April 3, 2015
Last Update Posted: February 23, 2017
Last Verified: February 2017