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A Multi-Center, Open-Label, Single-Arm, Phase 2 Study of ASONEP™ (Sonepcizumab/LT1009) Administered as a Single Agent to Subjects With Refractory Renal Cell Carcinoma

Phase 2
18 Years
Open (Enrolling)
Renal Cell Carcinoma

Thank you

Trial Information

A Multi-Center, Open-Label, Single-Arm, Phase 2 Study of ASONEP™ (Sonepcizumab/LT1009) Administered as a Single Agent to Subjects With Refractory Renal Cell Carcinoma

LT1009-Onc-002 is a Phase 2a open-label, multi-center study designed to evaluate the
efficacy and safety of ASONEP (sonepcizumab/LT1009) monotherapy in subjects with advanced,
unresectable, refractory RCC who have previously failed up to 3 therapies, including VEGF
and/or mTOR inhibitors. Two cohorts will be enrolled for a total of up to 39 subjects.
Subjects will receive an intravenous (IV) infusion of ASONEP™ over 90 minutes at 15 mg/kg
once a week and progression-free survival (PFS) will be assessed after 8 weeks of treatment.
Cohort 1 will enroll approximately 22 subjects. A second cohort of up to 17 subjects will be
enrolled if at least 12 out of 22 subjects from Cohort 1 demonstrated PFS at 8 weeks. Weekly
dosing will take place from the date of randomization until the date of first documented
progression or date of death from any cause, whichever comes first.

Inclusion Criteria:

- Unresectable, locally advanced recurrent or metastatic RCC

- Histological or cytological confirmation of clear cell RCC - core tissue biopsy of
either primary tumor or metastatic lesion with paraffin-embedded tissue specimens if
no prior nephrectomy

- Measurable disease by RECIST 1.1

- Had one prior therapy for unresectable RCC with a VEGF/VEGFR targeted therapy
(sunitinib, sorafenib, other VEGFR TKI or bevacizumab) - One prior treatment with an
mTOR inhibitor (everolimus, temsirolimus or sirolimus) for unresectable disease
permitted-Prior immunotherapy (immunomodulators such as cytokines, interleukins,
vaccines, etc.) such as IL-2 also permitted

- Male or non-pregnant, non-nursing female

- Life expectancy ≥3 months

- ECOG performance status of 0, 1 or 2

- Must not be receiving any concurrent anticancer therapy

- Baseline CT or MRI scans of measurable disease sites by RECIST 1.1 performed within 2
weeks of Day 0 - For subjects with bone metastases, baseline bone scan performed
within 4 weeks of study entry

- Adequate organ and immune function (within 7 days of Day 0):

Hemoglobin >9 g/dL−Absolute neutrophil count >1500 cells/uL without growth
factors−Platelet count ≥100x10^9/L without transfusion−Serum creatinine <2.0x ULN or
creatinine clearance >40 mL/min−Total bilirubin <1.5x ULN−AST/ALT <2.5x ULN (or <5.0x ULN
if liver metastases present)−INR and aPTT <1.5x ULN

- Subject lesions for arterial spin labeling (ASL) MRI ≥2.5cm by CT imaging

- Must understand, be able and willing to fully comply with study procedures

Exclusion Criteria:

- Prior treatment with >3 VEGF pathway and/or mTOR inhibitors for RC cancer

- History of other CNS disease (spinal cord compression, or evidence of symptomatic
brain or leptomeningeal carcinomatosis)

- Major surgery within 4 weeks of Day 0

- Radiation therapy within 4 weeks of baseline/infusion. Prior palliative radiation to
metastatic lesions is acceptable if there is at least one measurable, non-radiated

- Uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection requiring parenteral antibiotics on Day 0

- Known or suspected intolerance or hypersensitivity to study materials or any

- Evidence of bowel obstruction because of theoretical possibility of GI perforation
with an anti-angiogenesis agent

- Severe hemorrhage within 4 weeks of screening

- History of GI perforation

- History of non-healing wounds including ulcer or delayed bone fractures

- Prolonged QTc interval on baseline ECG (>450 msec for males or >470 msec for
females), cardiac dysrhythmias including atrial fibrillation, torsade de pointes,
ventricular tachycardia or fibrillation, pathologic sinus bradycardia (<60 bpm),
heart block (excluding 1st degree block, being PR interval prolongation only),
congenital long QT syndrome or new ST segment elevation or depression or new Q wave
on ECG

- Secondary malignancy within the last 5 years, except for adequately-treated basal
cell carcinoma, squamous cell skin cancer, superficial bladder tumors, or in situ
cervical cancer

- Previously enrolled in an sonepcizumab study or into this study and subsequently

- History of alcohol or other substance abuse within the last year

- Use of corticosteroids or other immunosuppression (if taking systemic steroids [vs.
topical], at least 4 weeks must have passed since the last dose)

- Growth factors within 1 week of screening

- Serious medical conditions that might be aggravated by treatment or limit compliance

- Cerebrovascular accident or transient ischemic attack, or pulmonary embolism within 6
months prior to screening

- Participation in another clinical trial

- Other severe or intercurrent acute or chronic medical or psychiatric condition or
laboratory abnormality that may increase risk associated with study participation or
study drug administration

Type of Study:


Study Design:

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

Outcome Measure:

Progression-Free Survival

Outcome Description:

The study will use a two-cohort design based on an 8-week PFS rate. Treatment will be considered promising if at least 12 out of the first 22 eligible subjects entered in the Cohort 1 of the study are progression free at Week 8. Enrollment of Cohort 2 will then proceed and be considered worthy of further evaluation if at least 25 out of 39 eligible subjects are progression free at Week 8. If no efficacy signal is observed after enrollment of 22 subjects in Cohort 1, the second cohort will not be enrolled and the clinical study may be stopped.

Outcome Time Frame:

8 weeks

Safety Issue:


Principal Investigator

France LaPierre-Holme

Investigator Role:

Study Director

Investigator Affiliation:

Executive Director of Development at Lpath


United States: Food and Drug Administration

Study ID:




Start Date:

February 2013

Completion Date:

March 2015

Related Keywords:

  • Renal Cell Carcinoma
  • Renal cell carcinoma
  • Renal cell cancer
  • Sonepcizumab
  • Carcinoma
  • Carcinoma, Renal Cell



Medical University of South CarolinaCharleston, South Carolina  29425-0721
Beth Israel Deaconess Medical CenterBoston, Massachusetts  02215
City of Hope Comprehensive Cancer CenterDuarte, California  91010
Florida Cancer SpecialistsFort Myers, Florida  33901
Tennessee OncologyNashville, Tennessee  37203