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Study Investigating Safety, Tolerability, Pharmacokinetics(PK) and Antitumor Activities of Anti-PD-1(Programmed Death-1) Monoclonal Antibody

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04068519
Recruitment Status : Active, not recruiting
First Posted : August 28, 2019
Last Update Posted : March 25, 2020
Sponsor:
Information provided by (Responsible Party):
BeiGene

Brief Summary:
Phase I/II Study Investigating Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activities of Anti-PD-1 Monoclonal Antibody BGBA317 in Chinese Patients with Advanced Solid Tumors.

Condition or disease Intervention/treatment Phase
Advanced Solid Tumors Drug: BGB-A317 Phase 1 Phase 2

Detailed Description:
This study is a dose verification, PK assessment of products derived from two manufacturing processes and scales (500L-FMP and 2000L-FMP; FMP: Final Manufacturing Process) and indication expansion clinical study of monoclonal antibody BGB-A317 conducted in Chinese subjects with advanced solid tumors, with a purpose of exploring the safety, tolerability, pharmacokinetics and preliminary efficacy. This study is carried out on the basis of a Phase IA multi-dose and dose-escalation study in Australia. All subjects will receive BGB-A317 until they have no evidence of continued clinical benefits, unacceptable toxicity, or withdrawal of informed consent in the discretion of the investigator. Paraffin-embedded tumor tissue will be collected for purpose of biomarker analysis.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 300 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I/II Study Investigating Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activities of Anti-PD-1 Monoclonal Antibody BGB-A317 in Chinese Patients With Advanced Solid Tumors
Actual Study Start Date : December 28, 2016
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2020

Arm Intervention/treatment
Experimental: BGB-A317 Drug: BGB-A317
Subjects will be treated with BGB A317 200 mg IV on Day 1 during each 21-day cycle. BGB A317 will be administered until disease progression, intolerable toxicity, or treatment discontinuation for any other reason.




Primary Outcome Measures :
  1. Phase I: Number and serious for Adverse Events (AEs) [ Time Frame: approximate 3 years ]
    To monitoring AEs and Serious Adverse Events(SAEs) per the NCI-CTCAE Version 4.03 (National Cancer institute-Common Toxicity Criteria Version 4.03, 2010), physical examination, electrocardiograms and laboratory assessments.

  2. Phase I: Maximum tolerated dose(MTD) (if any) and/or Recommended phases 2 dose (RP2D) [ Time Frame: approximate 1 year ]
    The MTD (if any) and/or RP2D (s) for BGB-A317 will be determined based on safety, tolerability, pharmacokinetics, preliminary efficacy, and other available data in dose verification study.

  3. Phase I:Maximum observed plasma concentration(Cmax) [ Time Frame: approximate 1 year ]
    Single-dose pharmacokinetic parameters Cmax will be assessed to evaluate the PK characteristics of BGB-A317 derived from both manufacturing processes and scales.

  4. Phase II: Objective response rate(ORR) [ Time Frame: approximate 2 years ]
    The ORR in different tumor types will be determined by the Investigator per Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1 to assess the preliminary anti-tumor activity

  5. Phase I:Area under the plasma concentration and time curve(AUC) [ Time Frame: approximate 1 year ]
    Single-dose pharmacokinetic parameters AUC will be assessed to evaluate the PK characteristics of BGB-A317 derived from both manufacturing processes and scales


Secondary Outcome Measures :
  1. Phase I: Terminal elimination half-life (t½) [ Time Frame: approximate 3 years ]
    To characterize the pharmacokinetics of BGB-A317 in dose verification study, to assess the PK of products derived from two manufacturing processes and scales (500L-FMP and 2000L-FMP) following the multiple doses of BGB-A317.

  2. Phase I: ORR [ Time Frame: approximate 3 years ]
    These parameters will be determined by Investigator per RECIST Version 1.1 to assess the preliminary anti-tumor activity of BGB-A317 and the two manufacturing processes and scales (500L-FMP and 2000L-FMP).

  3. Phase I:Progression-free survival(PFS) [ Time Frame: approximate 3 years ]
    These parameters will be determined by Investigator per RECIST Version 1.1 to assess the preliminary anti-tumor activity of BGB-A317 and the two manufacturing processes and scales (500L-FMP and 2000L-FMP).

  4. Phase I: Duration of response(DOR) [ Time Frame: approximate 3 years ]
    These parameters will be determined by Investigator per RECIST Version 1.1 to assess the preliminary anti-tumor activity of BGB-A317 and the two manufacturing processes and scales (500L-FMP and 2000L-FMP).

  5. Phase I: Overall survival(OS) [ Time Frame: approximate 3 years ]
    These parameters will be determined by Investigator per RECIST Version 1.1 to assess the preliminary anti-tumor activity of BGB-A317 and the two manufacturing processes and scales (500L-FMP and 2000L-FMP).

  6. Phase I: Anti-BGB-A317 antibody [ Time Frame: approximate 3 years ]
    immunogenic responses to BGB-A317 will be assessed by monitoring the occurrence of anti-drug antibody

  7. Phase II: PFS [ Time Frame: approximate 3 years ]
    To evaluate the efficacy by investigator based on RECIST Version 1.1

  8. Phase II: DOR [ Time Frame: approximate 3 years ]
    To evaluate the efficacy by investigator based on RECIST Version 1.1

  9. Phase II: OS [ Time Frame: approximate 3 years ]
    To evaluate the efficacy by investigator based on RECIST Version 1.1

  10. Phase II: Number and serious for adverse events [ Time Frame: approximate 3 years ]
    The safety and tolerability of BGB-A317 will be further assessed throughout the study by monitoring adverse events and serious adverse events per NCI CTCAE Version 4.03, physical examination, electrocardiograms and laboratory assessments.



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
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subjects must have histologically or cytologically confirmed advanced or metastatic tumors (unresectable), have had progression or intolerability since last standard anti-tumor treatment, or have no standard treatment or have refused standard therapy
  2. Subjects must be able to provide archival tumor tissues (paraffin blocks or at least 10 unstained tumor specimen slides
  3. Subjects must have at least one measurable lesion as defined per RECIST criterion Version 1.1
  4. Subject must have adequate organ
  5. Female subjects are eligible to participate in the study if they are: a) Non-childbearing potential (i.e., physiologically incapable of becoming pregnant) who: • Has had hysterectomy • Has had bilateral oophorectomy • Has had bilateral tubal ligation or are post-menopausal (total cessation of menses for ≥1 year) b) Childbearing potential: • Must be willing to use a highly effective method of birth control for the duration of the study, and for at least 120 days after the last dose of BGB-A317, and have a negative urine or serum pregnancy test within 7 days of the first dose of study drug
  6. Non-sterile males must be willing to use a highly effective method of birth control for the duration of the study

Exclusion Criteria:

  1. History of severe hypersensitivity reactions to other mAbs
  2. Prior malignancy active within the previous 2 years except for the tumor under investigation in this trial, cured or locally curable cancers, 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. Active brain or leptomeningeal metastases. Subjects with brain metastases are permitted if they are asymptomatic, eg, diagnosed incidentally by brain imaging, or subjects with previously treated brain metastases that are asymptomatic at screening, radiographically stable and not requiring steroid medications for at least 4 weeks prior to the first administration of study treatment
  5. Subjects with active autoimmune diseases or history of autoimmune diseases or immunodeficiency that may relapse should be excluded. Subjects with following diseases are allowed to be enrolled for further screening: type I diabetes, hypothyroidism managed with hormone replacement therapy only, skin diseases not requiring systemic treatment (such as vitiligo, psoriasis or alopecia), or diseases not expected to recur in the absence of external triggering factors
  6. Subjects should be excluded if they have a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications within 14 days of study drug administration.
  7. With uncontrollable pleural effusion, pericardial effusion or ascites requiring repeated drainage
  8. Use of any live or attenuated vaccines within 4 weeks (28 days) prior to initiation of study therapy
  9. Major surgical procedure (Grade 3 or 4) within the past 4 weeks (28 days) prior to study drug administration
  10. Prior allogeneic or solid organ transplantation

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): NCT04068519


Locations
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China, Beijing
Beijing Cancer Hospital
Beijing, Beijing, China, 100142
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing, China
China, Guangdong
The Fifth Affiliated Hospital, Su-Sen University
Guangzhou, Guangdong, China, 519000
Guangdong general hospital
Guangzhou, Guangdong, China
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen university
Guangzhou, Guangdong, China
China, Heilongjiang
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China, 150081
China, Jiangsu
Jiangsu Province hospital
Nanjing, Jiangsu, China
China, Jiangxi
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China, 330006
China, Shanghai
Fudan University Shanghai Cancer Center
Shanghai, Shanghai, China, 200032
Zhongshan Hospital Fudan University
Shanghai, Shanghai, China, 200032
China, Zhejiang
The Second Affiliated Hospital of Zhejiang University school of Medicine
Hangzhou, Zhejiang, China, 310009
Sir Run Run Shaw hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, China, 310016
Sponsors and Collaborators
BeiGene
Investigators
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Principal Investigator: Yilong Wu, PhD Guangdong Provincial People's Hospital
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Responsible Party: BeiGene
ClinicalTrials.gov Identifier: NCT04068519    
Other Study ID Numbers: BGB-A317-102
First Posted: August 28, 2019    Key Record Dates
Last Update Posted: March 25, 2020
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Upon request, and subject to certain criteria, conditions, and exceptions, BeiGene will provide access to individual de-identified participant data from BeiGene-sponsored global interventional clinical studies conducted for medicines for indications that have been approved or in programmes that have been terminated. BeiGene will also consider requests for the protocol, data dictionary, and statistical analysis plan. Data requests can be submitted to medicalinformation@beigene.com.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No