A Study of NBF-006 in Non-Small Cell Lung,Pancreatic, or Colorectal Cancer



Status:Recruiting
Conditions:Lung Cancer, Colorectal Cancer, Cancer, Cancer, Cancer, Cancer, Pancreatic Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:3/6/2019
Start Date:March 2019
End Date:August 2021

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A Phase I/Ib Open-Label, Multi-Center, Dose-Escalation Study to Investigate the Safety, Pharmacokinetics and Preliminary Efficacy of Intravenous NBF 006 in Patients With Non-Small Cell Lung, Pancreatic, or Colorectal Cancer

This is an open-label, non-controlled study to investigate the safety, efficacy and
pharmacokinetics (PK) of NBF-006 in patients with advanced non-small cell lung cancer
(NSCLC), pancreatic, or colorectal cancer.


Inclusion Criteria:

1. Part A: Patients with histologically or cytologically confirmed progressive or
metastatic NSCLC, pancreatic, or colorectal cancer that have failed standard treatment
and for which no other effective treatment is available for that patient.

Part B: Patients with histologically or cytologically confirmed progressive or
metastatic NSCLC with documented KRAS-mutant genotype that have failed standard
treatment and have no other effective treatment available.

2. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.

3. Men and women ≥ 18 years of age.

4. Patients must have recovered from all acute adverse effects (excluding alopecia) of
prior therapies to baseline or ≤ Grade 1 prior to study entry.

5. Adequate bone marrow function, defined as an absolute neutrophil count (ANC) ≥1.5 x
10^9/L and a platelet count ≥100 x 10^9/L.

6. Adequate renal function, defined as serum creatinine ≤1.5 X upper limit of normal
(ULN) for the institution or calculated creatinine clearance [Cockcroft-Gault method]
must be ≥ 60 mL/min/1.73 m^2. If serum creatinine is >1.5 x ULN, then creatinine
clearance can be calculated from a 24 hour urine collection.

7. Adequate hepatic function, defined as total bilirubin ≤ 1.5 mg/dL and alanine
transaminase (ALT) and aspartate transaminase (AST) ≤ 2.5 X ULN, or ≤ 5 X ULN if known
liver metastases.

8. Female patients of childbearing potential must have a negative serum or urine
pregnancy test result at time of pre-treatment screening.

9. Patients with reproductive potential must agree to use at least one form of barrier
contraception prior to study entry and for up to 30 days beyond the last
administration of study drug.

10. Patients must be capable of providing informed consent and must be willing to provide
written informed consent prior to the start of any study-specific procedures.

11. In Part B, all patients must have measurable tumor per RECIST 1.1.

Exclusion Criteria:

1. Prior chemotherapy, radiation therapy, or investigational therapy within 4 weeks
(exception: 6 weeks for nitrosoureas or mitomycin C); or prior non-cytotoxic therapy
within 5 drug half-lives (or 4 weeks, whichever is shorter); or monoclonal antibodies
within 4 weeks prior to the first dose of study treatment.

2. Concurrent use of any other investigational agent.

3. Known or clinically suspected central nervous system (CNS) or leptomeningeal
metastases, unless irradiated or treated a minimum of 4 weeks prior to first study
treatment and stable without requirement of corticosteroids for > 1 week.

4. Pregnant or breast feeding. A negative pregnancy test must be documented at baseline
for women of childbearing potential. Patients may not breast-feed infants while on
this study.

5. Significant cardiovascular disease or condition, including:

1. Congestive heart failure (CHF) currently requiring therapy

2. Need for antiarrhythmic medical therapy for ventricular arrhythmia

3. Severe conduction disturbance

4. Angina pectoris requiring therapy

5. QTc interval > 450 msec (males) or > 470 msec (females) Fridericia's correction
Note: QTc values up to 500 ms will be acceptable where patient's medical history
e.g. bundle branch block, is known to cause mild QTc prolongation and the
condition is well controlled.

6. History of congenital long QT syndrome or congenital short QT syndrome

7. Uncontrolled hypertension (per the Investigator's discretion)

8. Class III or IV cardiovascular disease according to the New York Heart
Association's (NYHA) Functional Criteria

9. Myocardial infarction (MI) within 6 months prior to first study drug
administration

6. Known history of human immunodeficiency virus (HIV) or active infection with hepatitis
B virus (HBV) or hepatitis C virus (HCV).

7. Psychiatric disorder or altered mental status that would preclude understanding of the
informed consent process and/or completion of the necessary studies.

8. Known allergic reactions to H1/H2 antagonists.
We found this trial at
1
site
5206 Research Drive
San Antonio, Texas 78240
Principal Investigator: Anthony Tolcher, MD
Phone: 210-580-9500
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mi
from
San Antonio, TX
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