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A Phase 1, Open-Label, Dose-Escalation Study Evaluating the Safety, Pharmacokinetics, Pharmacodynamics, and Clinical Effects of Intravenously Administered Nerofe™ in Subjects With Advanced Malignancies

Phase 1
18 Years
Open (Enrolling)

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Trial Information

A Phase 1, Open-Label, Dose-Escalation Study Evaluating the Safety, Pharmacokinetics, Pharmacodynamics, and Clinical Effects of Intravenously Administered Nerofe™ in Subjects With Advanced Malignancies

This is a Phase 1 single-center, open-label, non-randomized, dose-escalation study, to be
conducted in 2 phases. The Dose Escalation Phase will determine the maximum tolerated dose
(MTD) of Nerofe and evaluate its safety and tolerability, pharmacokinetics,
pharmacodynamics, immunogenicity, and preliminary clinical effects. The subsequent Dose
Confirmation Phase will be a cohort expansion at or below the MTD of Nerofe. Subjects will
be treated with IV doses of Nerofe thrice weekly (on alternating days) in consecutive,
28-day cycles. Subjects will be evaluated regularly for safety. Subjects who tolerate the
drug and who do not experience progressive disease, intolerable toxicity, or meet any of the
other withdrawal criteria may continue to receive Nerofe for up to 6 cycles, at the
discretion of the Principal Investigator. Throughout the trial, oversight will be provided
by the Clinical Safety Committee.

Inclusion Criteria:

1. Males and females at least 18 years of age.

2. Pathologically confirmed locally advanced and/or metastatic solid tumor for which
standard therapy proven to provide clinical benefit does not exist, is no longer
effective, or cannot be tolerated.

3. Evaluable disease, either measurable on physical examination or imaging by Response
Evaluation Criteria in Solid Tumors, or by informative tumor markers.

4. Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤1.

5. Acceptable clinical laboratory values at screening, as indicated by:

- Absolute neutrophil count ≥1,500/mm3;

- Platelets ≥75,000/mm3;

- Total bilirubin ≤1.5 × the upper limit of normal (ULN);

- AST (SGOT) ≤2.5 × the ULN;

- ALT (SGPT) ≤2.5 × the ULN;

- Serum creatinine ≤1.5 mg/dL; and

- Negative serum hCG test in women of childbearing potential.

6. Willing and able to provide written Informed Consent and comply with the requirements
of the study.

Exclusion Criteria:

1. Any chemotherapy, immunomodulatory drug therapy, anti-neoplastic hormonal therapy
(unless dose has been stable for 3 months), immunosuppressive therapy,
corticosteroids > 20 mg/day prednisone or equivalent, or growth factor treatment (eg,
erythropoietin) within 14 days prior to initiation of study drug.

2. Presence of an acute toxicity of prior chemotherapy, with the exception of alopecia
or peripheral neuropathy, that has not resolved to ≤ Grade 1, as determined by NCI
CTCAE v 4.0.

3. Life expectancy <20 weeks.

4. Major surgery or radiation therapy within 28 days prior to initiation of study drug.

5. Receipt of radiotherapy to >25 % of bone marrow.

6. Known human immunodeficiency virus (HIV) or acquired immunodeficiency
syndrome-related illness.

7. Known active hepatitis B or C or other active liver disease (other than malignancy).

8. Active infection requiring systemic therapy.

9. Uncontrolled congestive heart failure (New York Heart Association Classification 3 or
4), angina, myocardial infarction, cerebrovascular accident, coronary/peripheral
artery bypass graft surgery, transient ischemic attack, or pulmonary embolism within
3 months prior to initiation of study drug.

10. History of or ongoing cardiac dysrhythmias requiring treatment, atrial fibrillation
of any grade, or persistent prolongation of the QTc (Fridericia) interval to > 450
msec for males or > 470 msec for females.

11. Pregnant or lactating female.

12. Any severe, acute, or chronic medical or psychiatric condition, or laboratory
abnormality that may increase the risk associated with study participation.

Type of Study:


Study Design:

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

Outcome Measure:

Safety, as determined by frequency, nature, and severity of adverse events; and the profile of dose-limiting toxicities

Outcome Time Frame:

Up to 6 months

Safety Issue:


Principal Investigator

Yoram Devary, PhD

Investigator Role:

Study Director

Investigator Affiliation:

Immune System Key Ltd


Israel: Ministry of Health

Study ID:




Start Date:

April 2013

Completion Date:

October 2014

Related Keywords:

  • Cancer
  • Cancer
  • Malignancy
  • Solid tumors
  • Neoplasms