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Protocol NumberBGB-A317_Study_001
NCT Number(ClinicalTrials.gov Identfier)NCT02407990

2016-06-01 - 2019-05-31

Phase I

Terminated6

ICD-10C80.1

Malignant (primary) neoplasm, unspecified

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

  • Trial Applicant

    IQVIA RDS Taiwan Ltd.

  • Sponsor

    BeiGene Aus Pty Ltd

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2025/08/20

Investigators and Locations

Principal Investigator Chia-Jui Yen Division of Hematology & Oncology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Audit

None

Principal Investigator Kuan-Der Lee Division of Hematology & Oncology
Chiayi Chang Gung Memorial Hospital of the C.G.M.F.

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator 饒坤銘 Division of Hematology & Oncology
Kaoshiung Chang Gung Memorial Hospital of the C.G.M.F.

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator Yee Chao Division of Hematology & Oncology
Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

9 Terminated

Audit

None

Principal Investigator Ming-Mo Hou Division of Hematology & Oncology
Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

9 Terminated

Audit

CRO

Principal Investigator Chia-Chi Lin Division of Hematology & Oncology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Audit

None

Condition/Disease

Advanced Tumors

Objectives

Phase 1A Primary:  To assess the safety and tolerability of BGB-A317 in subjects with advanced tumors. Secondary:  To characterize the pharmacokinetics of BGB-A317.  To determine maximum tolerated dose (MTD), if any, and recommended Phase II dose (RP2D) for BGB-A317.  To assess the preliminary anti-tumor activity of BGB-A317.  To assess host immunogenicity to BGB-A317. Exploratory:  To assess potential pharmacodynamic biomarkers.  To assess potential predictive biomarkers.  To explore mechanisms of treatment resistance in subjects who have failed to respond or developed resistance. Phase 1B Primary:  To assess the anti-tumor activity of BGB-A317 in select tumor types. Secondary:  To further assess the safety and tolerability of BGB-A317 in subjects with advanced tumors.  To further characterize the pharmacokinetics of BGB-A317. Exploratory:  To explore potential pharmacodynamic biomarkers  To explore potential predictive biomarkers.  To explore mechanisms of treatment resistance in subjects who have failed to respond or developed resistance

Test Drug

BGB-A317

Active Ingredient

BGB-A317

Dosage Form

Injection

Dosage

100

Endpoints

Primary Endpoints:
The primary endpoint of the Phase 1A stage is the following:
• BGB-A317 safety and tolerability: The safety of BGB-A317 will be assessed throughout the study by
monitoring adverse events (AEs) per the NCI-CTCAE Version 4.03, physical examination,
ophthalmologic examination, electrocardiograms, laboratory measurements and severity of adverse
events.
The primary endpoint of the Phase 1B stage is the following:
• Objective response rate (ORR: complete response [CR] + partial response [PR]) based on RECIST
Version 1.1 in subjects with select tumor types as evaluated by the Investigators.
Secondary Endpoints:
The secondary endpoints of the Phase 1A stage of the study are the following:
• Pharmacokinetic evaluations: include but not limited to AUC0-14 day, Cmax and Tmax, Ctrough, t½, Cl and Vd.
• The MTD, if any, and RP2D (s) for BGB-A317 will be determined based on safety, tolerability,
pharmacokinetics, preliminary efficacy, and other available data.
• Efficacy evaluations: ORR (CR+PR), CR rate, PR rate, stable disease (SD) rate, progression-free
survival (PFS), overall survival (OS) and duration of response and duration of SD will be determined
based on RECIST Version 1.1 and the results of Investigator evaluations.
• Anti-BGB-A317 antibody: immunogenic responses to BGB-A317 will be assessed to determine
occurrence of anti-drug antibody.
The secondary endpoints of the Phase 1B stage of the study are the following:
• PFS as described above; disease control rate (DCR: CR + PR + SD); and clinical benefit rate (CBR: CR
or PR or durable SD [SD ≥24 weeks]).
• Safety and tolerability assessment of AEs, SAEs, physical examination, ophthalmologic examination,
vital signs, ECG, and laboratory measurements.
• Plasma concentrations of BGB-A317 at selected time points.

Inclution Criteria

Key inclusion criteria:
1. Subjects meet the following corresponding requirements for the
stage of the study they will enroll into:
a) In Phase 1A stage of the study, subjects must have a
histologically or cytologically confirmed advanced or metastatic
tumor for which no effective standard therapy is available,
including but not limited to CRC, NSCLC, melanoma, SCC,
uveal melanoma, gastric cancer, pancreatic cancer, ovarian
cancer, bladder cancer, HNSCC, RCC, TNBC and HCC.
b) In Phase 1B stage of the study, subjects recruited to one of the
following expansion arms must have histologically or
cytologically confirmed advanced or metastatic tumor (of the
types described below) for which no effective standard therapy
is available:
• Arm 1. Subjects with NSCLC
• Arm 2. Subjects with ovarian cancer
• Arm 3. Subjects with gastric cancer
• Arm 4. Subjects with HCC (BCLC stage C and ChildPugh A)
• Arm 5. Subjects with HNSCC
• Arm 6. Subjects with esophageal carcinoma
• Arm 7. Subjects with TNBC
• Arm 8. Subjects with cholangiocarcinoma, CRC or
pancreatic cancer
• Arm 9. Subjects with RCC, bladder cancer, melanoma,
Merkel-cell carcinoma, sarcoma or any other solid
tumors not covered in arms 1 to 8
2. Subjects with previously treated brain metastasis(es) that is
asymptomatic or radiographically/clinically stable and not
requiring steroid 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).
For Arm 2 (ovarian cancer), Arm 3 (gastric cancer), and Arm
4 (HCC) of Phase 1B study, a fresh baseline biopsy within 8
weeks of starting treatment is mandatory for biomarker
analysis.
For Arm 9 (melanoma) of Phase 1B study, a fresh baseline
biopsy within 8 weeks of starting treatment and one
approximately on Cycle 3 Day 1 are mandatory for biomarker
analysis.
All other subjects who have easily accessible lesions are
strongly recommended for baseline or the paired biopsy.
Subjects may be permitted to enroll on a case-by-case basis after
discussion with the medical monitor and in consultation with the
Sponsor if tissue or biopsy is not available.
4. Subjects must have at least one measurable lesion as defined per
RECIST Version 1.1. Subjects with mCRPC and with only nonmeasurable bone lesions must have either progression with 2 or
more new lesions or have prostate-specific antigen (PSA)
progression within the 6-week period before study drug
administration.
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. Life expectancy ≥12 weeks.
8. Subject must have adequate organ function as indicated by the
following laboratory values.
a) Absolute neutrophil count (ANC) ≥1,500 /mcL
b) Platelets ≥100,000 / mcL
c) Hemoglobin ≥9 g/dL or ≥5.6 mmol/L
d) Serum creatinine ≤1.5 X upper limit of normal (ULN)
e) Serum total bilirubin ≤ 1.5 X ULN (total bilirubin must be <4
X ULN for subjects with Gilbert’s syndrome)
f) AST (SGOT) and ALT (SGPT) ≤ 2.5 X ULN OR ≤ 5 X ULN
for subjects with liver metastases or HCC
g) International Normalized Ratio (INR) or Prothrombin Time
(PT) ≤1.5 X ULN
h) Activated Partial Thromboplastin Time (aPTT) ≤1.5 X ULN
9. Subjects have voluntarily agreed to participate by giving written
informed consent.
10. Female subjects are eligible to enter and participate in the study if
they are of:
a) 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).
b) 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.
11. Male subjects are eligible to participate in the study if they are
vasectomized or agree to use of contraception during the study
treatment period and for at least 180 days after the last dose of
study drug.

Exclusion Criteria

Key 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 subject 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 failed to meet enrollment criteria for other PD-1 or
PD-L1 trials solely due to low or negative predictive biomarkers,
including but not limited to PD-L1, microsatellite instability
(MSI), and DNA mutation load.
5. Subjects with active autoimmune diseases or history of
autoimmune diseases should be excluded; these include but are not
limited to subjects with a history of immune related neurologic
disease, multiple sclerosis, autoimmune (demyelinating)
neuropathy, Guillain-Barre syndrome, myasthenia gravis, systemic
lupus erythematosus (SLE), connective tissue diseases,
scleroderma, inflammatory bowel disease including Crohn’s
disease and ulcerative colitis, hepatitis, toxic epidermal necrolysis
(TEN), Stevens-Johnson syndrome, or phospholipid syndrome.
Note: Subject are permitted to enroll if they have vitiligo, eczema,
type I diabetes mellitus, endocrine deficiencies including
thyroiditis managed with replacement hormones including
physiologic corticosteroids. Subjects with rheumatoid arthritis and
other arthropathies, Sjogren's syndrome and psoriasis controlled
with topical medication and subjects with positive serology, such
as antinuclear antibodies (ANA), anti-thyroid antibodies should be
evaluated for the presence of target organ involvement and
potential need for systemic treatment but should otherwise be
eligible.
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.
Note: Adrenal replacement doses ≤ 10 mg daily prednisone
equivalents are permitted in the absence of active autoimmune
disease; subjects are permitted to use topical, ocular, intraarticular, intranasal, and inhalational corticosteroids (with minimal
systemic absorption); a brief course of corticosteroids for
prophylaxis (e.g., contrast dye allergy) or for treatment of nonautoimmune conditions (e.g., delayed-type hypersensitivity
reaction caused by contact allergen) is permitted
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. Except for HCC in Phase 1A or Arm 4 in Phase 1B, subjects who
are Hepatitis B surface antigen (HBsAg) and Hepatitis B core
antibody (HBcAb) positive or Hepatitis C virus (HCV) antibody
positive at screening must not be enrolled until further definite
testing with Hepatitis B virus (HBV) DNA titres and HCV RNA
tests can conclusively rule out presence of active infection
requiring therapy with Hepatitis B and C, respectively.
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 any intended use until 60 days after the last
administration of the study medication.

The Estimated Number of Participants

  • Taiwan

    70 participants

  • Global

    220 participants

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