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

NCT03819387 | Completed Phase 1 FDA Drug

• 1 other identifier: NBF-006-001
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 9

Brief Summary

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

Conditions

Non-Small Cell Lung Cancer; Pancreatic Cancer; Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

• Number of patients with treatment-related adverse events as assessed by CTCAE v5.0

  Change in the incidence and severity of adverse events related to study treatment from baseline to 4 weeks following last dose

Secondary Outcomes (3)

• Best Overall Response per RECIST 1.1

  Number of days from date of first dose to 30 days after last treatment

• Pharmacokinetic parameters for siRNA

  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

• Additional pharmacokinetic parameters for siRNA

  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

Other Outcomes (2)

• To evaluate correlation between biomarkers and clinical outcome

  Number of days from date of first dose to 30 days after last treatment

• To evaluate correlation between KRAS mutations and clinical outcome

  Number of days from date of first dose to 30 days after last treatment

Study Arms (1)

NBF-006

EXPERIMENTAL

Drug: NBF-006

Interventions

NBF-006 DRUG

Intravenous infusion, once-weekly x 4 consecutive weeks, every 6 weeks

NBF-006

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Eastern Cooperative Oncology Group performance status of 0-2.
• Men and women ≥ 18 years of age.
• Patients must have recovered from all acute adverse effects (excluding alopecia) of prior therapies to baseline or ≤ Grade 1 prior to study entry.
• Adequate bone marrow function, defined as an absolute neutrophil count (ANC) ≥ 1.5 x 109/L and a platelet count ≥ 100 x 109/L.
• 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.
• 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.
• Female patients of childbearing potential must have a negative serum or urine pregnancy test result at time of pre-treatment screening.
• 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.
• 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.
• All patients must have measurable tumor per RECIST 1.1.
• Agree to adhere to all study protocol requirements.

You may not qualify if:

• 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.
• Concurrent use of any other investigational agent.
• 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.
• 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.
• Significant cardiovascular disease or condition, including:
• Congestive heart failure currently requiring therapy
• Need for antiarrhythmic medical therapy for ventricular arrhythmia
• Severe conduction disturbance
• Angina pectoris requiring therapy
• 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.
• History of congenital long QT syndrome or congenital short QT syndrome
• Uncontrolled hypertension (per the Investigator's discretion)
• Class III or IV cardiovascular disease according to the New York Heart Association's Functional Criteria
• Myocardial infarction within 6 months prior to first study drug administration

Sponsors & Collaborators

• Nitto BioPharma, Inc.: lead

Study Sites (9)

Beverly Hills Cancer Center

Beverly Hills, California, 90211, United States

Location

UC San Diego Moores Cancer Center

La Jolla, California, 92093, United States

Location

Moffitt Cancer Center

Tampa, Florida, 33612, United States

Location

University of Toledo, Eleanor N. Dana Cancer Center

Toledo, Ohio, 43614, United States

Location

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, 37203, United States

Location

NEXT Oncology - Austin

Austin, Texas, 78758, United States

Location

Mary Crowley Cancer Research Center

Dallas, Texas, 75230, United States

Location

NEXT Oncology - San Antonio

San Antonio, Texas, 78240, United States

Location

NEXT Oncology - Virginia

Fairfax, Virginia, 22031, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Pancreatic Neoplasms; Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Digestive System Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2019
• First Posted: January 28, 2019
• Study Start: March 18, 2019
• Primary Completion: November 2, 2023
• Study Completion: March 12, 2024
• Last Updated: July 24, 2024

Record last verified: 2024-07

Locations

US (9)