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A Phase I Study of the Safety and Pharmacokinetics of a Fully Human Monoclonal Antibody to the Vascular Endothelial Growth Factor Receptor2 (Tanibirumab) in Patients With Advanced Cancers or Metastatic Cancer

Phase 1
20 Years
Open (Enrolling)
Advanced Cancer, Metastatic Cancer

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Trial Information

A Phase I Study of the Safety and Pharmacokinetics of a Fully Human Monoclonal Antibody to the Vascular Endothelial Growth Factor Receptor2 (Tanibirumab) in Patients With Advanced Cancers or Metastatic Cancer

This is a Phase I, first-in-human, open-label, non-randomized, dose-escalating study of
Tanibirumab which is a fully human monoclonal antibody to vascular endothelial growth factor
receptor 2 (VEGFR2/KDR). This study will enroll patients with advanced or metastatic cancer
who are refractory or for whom there are no standard therapeutic options. Tanibirumab will
be administered intravenously to such patients over 60 minutes on Day 1, 8, and 15 (subject
to change pending PK and toxicity data). Each treatment cycle will be a minimum of 28 days
in length. The dose escalation study employing a 3 + 3 design is designed to identify the
RP2D which will be based on safety, tolerability and PK of the RP2D. This study is expected
to enroll a total of approximately 18-24 patients.

Inclusion Criteria:

- Age > 20 years

- Signed informed consent

- Histologically documented, incurable, locally advanced or metastatic cancers that
have failed to respond to at least one prior regimen or for which there is no
standard therapy.

- Disease that is measurable or evaluable by RECIST 1.1 criteria (for Solid Tumors)

- ECOG performance status 0-2

- Documented negative pregnancy test for women of childbearing potential and use of an
effective means of contraception for both men and women while enrolled in the study

- Granulocyte count ≥ 1,500/㎣, platelet count ≥ 100,000/㎣, and hemoglobin ≥ 9 g/dL

- Serum bilirubin ≤ 1.5 x upper limit of normal (ULN)(≤ 3 x ULN if liver metastatic

- Alkline phosphatase, AST and ALT ≤ 2.5 x ULN (≤ 5 x ULN if liver metastatic cancer)

- Serum creatinine ≤ 1.5 mg/dL

- INR (international normalized ratio) ≤ 1.3, and aPTT (activated partial
thromboplastin time) ≤ 1.5 x ULN

- Subject had to have a projected life expectancy of at least 3 months

- Bazetts correction QTc < 450 msec in ECG at Screening

Exclusion Criteria:

- Less than 4 weeks since last chemotherapy (including biologic unless previous Avastin
treatment, experimental, and hormonal therapy), radiation therapy, or major surgical

- All incisions from any procedure must be fully healed and sutures removed prior to
infusion on Day 1

- Pleural effusions, ascites, or leptomeningeal disease as the only manifestation of
the current malignancy

- Subjects that have hypertension that is remained uncontrolled, despite drug regimen.

- Subjects with grade III or IV hemorrhage/bleeding and who have experienced pulmonary
hemorrhage/hemoptysis (exceed size of 2.5 mL of erythrocyte) or who have experienced
grade III/IV hemorrhage/bleeding.

- The presence of gastrointestinal perforation

- The presence of tracheoesophageal fistula or grade Ⅳ fistula

- Subjects with grade Ⅳ proteinuria (nephritic syndrome)

- The presence of arterial thromboembolic events

- Subjects who have history of life threatening (grade Ⅳ) pulmonary embolism

- Subjects with a known hypersensitivity to CHO cell product or other recombined human
or humanized antibody

- Subjects with mental illness

- Subjects with a known hypersensitivity to any of the ingredients/substrates in
investigational product of this study

- Subjects who given any investigational drug within longer period between 30 days and
5 times of half life before participation in this study

- Active infection requiring IV antibiotics

- Active autoimmune disease that is not controlled by drugs

- Clinically important history of liver disease, including viral or other active
hepatitis, current alcohol abuse, or cirrhosis

- Known human immunodeficiency virus (HIV) infection

- Any other diseases, metabolic dysfunction, physical examination finding, or clinical
laboratory finding giving reasonable suspicion of a disease or condition that
contraindicates the use of an investigational drug or that may affect the
interpretation of the results or renders the subjects at high risk from treatment

- Significant traumatic injury within 3 weeks of Day 1

- Inability to comply with study and follow-up procedures

Type of Study:


Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety and tolerability

Outcome Description:

The safety and tolerability of Tanibirumab will be assessed using the following measures: frequency and nature of dose-limiting toxicities (DLTs); nature, severity, and relatedness of adverse events, graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events, v4.0; changes in vital signs; and changes in clinical laboratory parameters.

Outcome Time Frame:


Safety Issue:


Principal Investigator

Young Seok Park, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Samsung Medical Center


Korea: Food and Drug Administration

Study ID:




Start Date:

November 2011

Completion Date:

August 2013

Related Keywords:

  • Advanced Cancer
  • Metastatic Cancer
  • Tanibirumab Phase I trial
  • Neoplasm Metastasis
  • Neoplasms
  • Neoplasms, Second Primary