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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02407990




Registration number
NCT02407990
Ethics application status
Date submitted
26/03/2015
Date registered
3/04/2015
Date last updated
25/03/2020

Titles & IDs
Public title
Study of the Safety, Pharmacokinetics and Antitumor Activities of BGB-A317 in Participants With Advanced Tumors
Scientific 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
Secondary ID [1] 0 0
BGB-A317_Study_001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced Cancer 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - BGB-A317
Other interventions - BGB-A317

Experimental: BGB-A317 Phase 1A -

Experimental: BGB-A317 Phase 1B -


Other interventions: BGB-A317
In the dose escalation part, the dose levels will be escalated following a modified 3+3 dose escalation scheme. In the schedule exploration part, patients will be assigned to doses and dose schedules. In the fix dose exploration, patients will be assigned to dose group(s) not to exceed the Maximum Tolerated Dose (MTD).
In the dose expansion part, patients will be assigned to different groups based on their tumor type.

Other interventions: BGB-A317
Patients will be assigned to different groups based on their tumor types

Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Phase 1A: Number of participants with adverse events
Timepoint [1] 0 0
From first dose to within 30 days of last dose of BGB-A317, up to 2 years and 1 month
Primary outcome [2] 0 0
Phase 1B: Overall response based on RECIST v 1.1 in participants with select tumor types by the Investigators
Timepoint [2] 0 0
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
Secondary outcome [1] 0 0
Phase 1A: Area under the plasma concentration-time curve (AUC)
Timepoint [1] 0 0
During first 4 months
Secondary outcome [2] 0 0
Phase 1A: Maximum plasma concentration (Cmax)
Timepoint [2] 0 0
During first 4 months
Secondary outcome [3] 0 0
Phase 1A: Time to reach maximum plasma concentration (Tmax)
Timepoint [3] 0 0
During first 4 months
Secondary outcome [4] 0 0
Phase 1A: Terminal elimination half-life (t1/2)
Timepoint [4] 0 0
During first 4 months
Secondary outcome [5] 0 0
Phase 1A: Disease assessment by CT/MRI scan
Timepoint [5] 0 0
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
Secondary outcome [6] 0 0
Phase 1A: Anti-BGB-A317 antibody
Timepoint [6] 0 0
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
Secondary outcome [7] 0 0
Phase 1B: Disease assessment by CT/MRI scan
Timepoint [7] 0 0
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
Secondary outcome [8] 0 0
Phase 1B: Number of participants with adverse events
Timepoint [8] 0 0
From first dose to within 30 days of last dose of BGB-A317, up to 2 years and 1 month
Secondary outcome [9] 0 0
Phase 1B: Plasma concentration
Timepoint [9] 0 0
During first 4 months

Eligibility
Key inclusion criteria
Key

1. Participants must have a histologically or cytologically confirmed advanced or
metastatic tumor for which no effective standard therapy is available.

1. For Phase 1A: no specific restriction

2. For Phase 1B: histology specified below

i. NSCLC (Participants with documented epidermal growth factor receptor (EGFR)
mutation or anaplastic lymphoma kinase (ALK) rearrangement should be excluded) ii.
ovarian cancer iii. gastric cancer iv. HCC (Barcelona-Clinic Liver Cancer stage C,
stage B not amenable to locoregional therapy or refractory to locoregional therapy,
and not amenable to a curative treatment approach, and Child-Pugh A) v. HNSCC vi.
esophageal carcinoma vii. Triple Negative Breast Cancer (TNBC) viii.
cholangiocarcinoma ix. Renal Cell Cancer (RCC), bladder cancer, melanoma, Merkel-cell
carcinoma, sarcoma, gastrointestinal stromal tumor (GIST), or Cutaneous squamous cell
carcinoma (cuSCC). Or any other solid tumors with known microsatellite
instability-high (MSI-H) or deficient MisMatch Repair (dMMR) status, such as
Colorectal Cancer (CRC) or pancreatic cancer

2. Participants 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. Participants 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 participants with readily accessible tumor
lesions and who consent to the biopsies.)

4. Participants 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. Participants 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 participants with liver
metastases

- International Normalized Ratio (INR) or Prothrombin Time (PT) =1.5 X ULN

- Activated Partial Thromboplastin Time (aPTT) =1.5 X ULN

Key
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. History of severe hypersensitivity reactions to other Monoclonal antibodies (mAbs).

2. Prior malignancy active within the previous 2 years except for tumor for which a
participant 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. Participants who fail to meet enrollment criteria for other PD-1 or PD-L1 trials
solely due to low or negative predictive biomarkers.

5. Participants with active autoimmune diseases or history of autoimmune diseases should
be excluded.

6. Participants 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) except in participant with HCC, who meet the
following criteria:

- HBV viral load (VL) <200 IU/mL (approximately 1000 cps/mL)

- Participants with active Hepatitis B Virus (HBV) infection need to be on anti-HBV
suppression =3 months, throughout treatment and for 6 months after

- Participants Hepatitis C Virus (HCV)-positive after successful treatment (defined
as sustained virologic response [SVR] 12 or SVR 24) are allowed as long as 4
weeks have passed between completion of HCV therapy and start of study drug

10. 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.

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

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Chris O'Brien Lifehouse - Camperdown
Recruitment hospital [2] 0 0
Prince of Wales Hospital - Sydney
Recruitment hospital [3] 0 0
Tasman Oncology Research Ltd - Southport
Recruitment hospital [4] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [5] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [6] 0 0
The Queen Elizabeth Hospital - Woodville South
Recruitment hospital [7] 0 0
Monash Health - Clayton
Recruitment hospital [8] 0 0
Peter MacCallum Cancer Centre - East Melbourne
Recruitment hospital [9] 0 0
Austin Health Hospital - Heidelberg
Recruitment hospital [10] 0 0
Cabrini Hospital - Malvern
Recruitment hospital [11] 0 0
Nucleus Network - Melbourne
Recruitment hospital [12] 0 0
Royal Melbourne Hospital - Melbourne
Recruitment hospital [13] 0 0
Linear Clinical Research/Sir Charles Gairdner Hospital - Nedlands
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
- Sydney
Recruitment postcode(s) [3] 0 0
4216 - Southport
Recruitment postcode(s) [4] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [5] 0 0
- Adelaide
Recruitment postcode(s) [6] 0 0
- Woodville South
Recruitment postcode(s) [7] 0 0
- Clayton
Recruitment postcode(s) [8] 0 0
- East Melbourne
Recruitment postcode(s) [9] 0 0
- Heidelberg
Recruitment postcode(s) [10] 0 0
3144 - Malvern
Recruitment postcode(s) [11] 0 0
3004 - Melbourne
Recruitment postcode(s) [12] 0 0
- Melbourne
Recruitment postcode(s) [13] 0 0
- Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Massachusetts
Country [2] 0 0
United States of America
State/province [2] 0 0
Texas
Country [3] 0 0
Korea, Republic of
State/province [3] 0 0
Kyeonggi-do
Country [4] 0 0
Korea, Republic of
State/province [4] 0 0
Seoul
Country [5] 0 0
New Zealand
State/province [5] 0 0
Grafton
Country [6] 0 0
New Zealand
State/province [6] 0 0
Hamilton
Country [7] 0 0
New Zealand
State/province [7] 0 0
Wellington
Country [8] 0 0
Taiwan
State/province [8] 0 0
Kaohsiung
Country [9] 0 0
Taiwan
State/province [9] 0 0
Tainan
Country [10] 0 0
Taiwan
State/province [10] 0 0
Taipei
Country [11] 0 0
Taiwan
State/province [11] 0 0
Taoyuan

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
BeiGene
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This study will evaluate the safety, tolerability, pharmacokinetic profile and treatment
effect of a new drug known as BGB-A317 in participants with advanced tumors.
Trial website
https://clinicaltrials.gov/show/NCT02407990
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Jayesh Desai, MD
Address 0 0
Peter MacCallum Cancer Centre, Australia
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications