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

• ClinicalTrials.gov Identifier: NCT03819387
• Recruitment Status: Recruiting
• First Posted: January 28, 2019
• Last Update Posted: September 11, 2019
• Sponsor: Nitto BioPharma, Inc.
• Information provided by (Responsible Party): Nitto BioPharma, Inc.

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Non-Small Cell Lung Cancer; Pancreatic Cancer; Colorectal Cancer	Drug: NBF-006	Phase 1

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 30 participants
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: 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
• Actual Study Start Date: March 18, 2019
• Estimated Primary Completion Date: February 2021
• Estimated Study Completion Date: August 2021

Arms and Interventions

Arm	Intervention/treatment
Experimental: NBF-006	Drug: NBF-006; Intravenous infusion, once-weekly x 4 consecutive weeks, every 6 weeks

Outcome Measures

Primary Outcome Measures :

1. Number of patients with treatment-related adverse events as assessed by CTCAE v5.0 [ Time Frame: Change in the incidence and severity of adverse events related to study treatment from baseline to 4 weeks following last dose ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Locations

United States, Ohio

University of Toledo, Eleanor N. Dana Cancer Center; Recruiting

Toledo, Ohio, United States, 43614

Contact: Stephanie Smiddy, RN, BSN 419-383-4000 ext 6962 stephanie.smiddy@utoledo.edu

Principal Investigator: John J Nemunaitis, MD

United States, Texas

Next Oncology; Recruiting

San Antonio, Texas, United States, 78240

Contact: Sarah Gomez 210-580-9500 sgomez@nextoncology.com

Principal Investigator: Anthony Tolcher, MD

Sponsors and Collaborators

Nitto BioPharma, Inc.

More Information

• Responsible Party: Nitto BioPharma, Inc.
• ClinicalTrials.gov Identifier: NCT03819387 History of Changes
• Other Study ID Numbers: NBF-006-001
• First Posted: January 28, 2019
• Last Update Posted: September 11, 2019
• Last Verified: September 2019

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Colorectal Neoplasms; Neoplasms by Site; Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Colonic Diseases; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases