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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03819387
Recruitment Status : Recruiting
First Posted : January 28, 2019
Last Update Posted : April 19, 2021
Sponsor:
Information provided by (Responsible Party):
Nitto BioPharma, Inc.

Brief Summary:
This is an open-label, non-controlled study conducted in two parts - Part A (dose escalation) followed by Part B (dose expansion).

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

Detailed Description:

Patients in Part A will have previously treated progressive or metastatic NSCLC, pancreatic, or colorectal cancer, with or without KRAS mutation. Five dose levels will be explored. In dose level 5, only patients with previously-treated NSCLC with KRAS mutation will be included.

Patients in Part B must have previously treated NSCLC with confirmed KRAS mutation. Two dose levels will be explored further in Part B. Twenty (20) patients will be enrolled in Part B, with 10 patients enrolled in each of the two cohorts. Once dose level 5 has been confirmed to be safe in Part A (i.e. 0-1 DLT in 6 patients), an additional 4 patients will then be enrolled for a planned total of 24 patients in Part B.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 44 participants
Allocation: N/A
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 Followed by a Dose Expansion Study in Patients With KRAS-Mutated Non-Small Cell Lung Cancer
Actual Study Start Date : March 18, 2019
Estimated Primary Completion Date : August 2022
Estimated Study Completion Date : March 2023

Resource links provided by the National Library of Medicine


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




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 ]

Secondary Outcome Measures :
  1. Best Overall Response per RECIST 1.1 [ Time Frame: Number of days from date of first dose to 30 days after last treatment ]
    The rate of complete remission (CR) + partial remission (PR) + stable disease (SD)

  2. Pharmacokinetic parameters for siRNA [ Time Frame: Up to 72 hours from start of infusion on Cycle 1, Day 1 and Day 22 and prior to infusion Cycle 1, Day 8 and Cycle 2, Day 1 ]
    Peak Plasma Concentration (Cmax)

  3. Additional pharmacokinetic parameters for siRNA [ Time Frame: Up to 72 hours from start of infusion on Cycle 1, Day 1 and Day 22 and prior to infusion Cycle 1, Day 8 and Cycle 2, Day 1 ]
    Area under the plasma concentration versus time curve (AUC)


Other Outcome Measures:
  1. To evaluate correlation between biomarkers and clinical outcome [ Time Frame: Number of days from date of first dose to 30 days after last treatment ]
    analysis of ADAs, immune activation biomarkers, GSTP knockdown, and other biomarker activity

  2. To evaluate correlation between KRAS mutations and clinical outcome [ Time Frame: Number of days from date of first dose to 30 days after last treatment ]


Information from the National Library of Medicine

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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 or appropriate for the patient up to dose level 4. In dose level 5, patients with histologically or cytologically confirmed progressive or metastatic NSCLC with documented KRAS-mutant genotype, who have failed standard treatment and have no other effective treatment available or appropriate for the patient.

    Part B: Patients with histologically or cytologically confirmed progressive or metastatic NSCLC with documented KRAS-mutant genotype, who have failed standard treatment and have no other effective treatment available or appropriate for the patient.

  2. Eastern Cooperative Oncology Group 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 109/L and a platelet count ≥ 100 x 109/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 m². 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 highly effective 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. All patients must have measurable tumor per RECIST 1.1.
  12. Agree to adhere to all study protocol requirements.

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 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 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 Functional Criteria
    9. Myocardial infarction within 6 months prior to first study drug administration
  6. Known history of human immunodeficiency virus or active infection with hepatitis B virus or hepatitis C virus.
  7. Known uncontrolled intercurrent illnesses, including uncontrolled viral influenza and COVID 19, systemic bacterial infections, and fungal infections.
  8. Psychiatric disorder or altered mental status that would preclude understanding of the informed consent process and/or completion of the necessary studies.
  9. Known allergic reactions to H1/H2 antagonists.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03819387


Contacts
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Contact: Zachary Albaugh 609-917-4701 zalbaugh@theradex.com
Contact: Gianfranco Beniamini 609-619-7663 gbeniamini@theradex.com

Locations
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United States, Ohio
University of Toledo, Eleanor N. Dana Cancer Center Recruiting
Toledo, Ohio, United States, 43614
Contact: Stephanie Smiddy, RN, BSN    419-383-6962    stephanie.smiddy@utoledo.edu   
Principal Investigator: Roland Skeel, MD         
United States, Texas
Next Oncology Recruiting
San Antonio, Texas, United States, 78240
Contact: Amanda Betancourt    210-289-0575    abetancourt@nextoncology.com   
Principal Investigator: Anthony Tolcher, MD         
Sponsors and Collaborators
Nitto BioPharma, Inc.
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Responsible Party: Nitto BioPharma, Inc.
ClinicalTrials.gov Identifier: NCT03819387    
Other Study ID Numbers: NBF-006-001
First Posted: January 28, 2019    Key Record Dates
Last Update Posted: April 19, 2021
Last Verified: April 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Colorectal Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases