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NBF-006 for Cancer

Phase 1

Waitlist Available

Research Sponsored by Nitto BioPharma, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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.

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.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 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

Awards & highlights

Study Summary

This trial is testing a new cancer treatment to see if it is safe and effective. The first part of the trial is to see what dose is safe, and the second part is to see if the treatment works.

Who is the study for?

This trial is for adults (18+) with certain types of advanced cancers (NSCLC, pancreatic, colorectal) that have worsened despite standard treatments. Participants must have good liver and kidney function, not be pregnant or breastfeeding, agree to use contraception, and cannot have HIV or active hepatitis B/C infections. They should not have had recent chemotherapy or suffer from severe psychiatric disorders or uncontrolled heart disease.Check my eligibility

What is being tested?

NBF-006 is being tested in patients with specific advanced cancers. The study has two parts: Part A finds the best dose of NBF-006 and Part B sees how well it works at that dose. It's an open-label trial which means everyone knows what treatment they're getting; there's no placebo group.See study design

What are the potential side effects?

While the exact side effects of NBF-006 are not listed here, similar cancer drugs often cause fatigue, nausea, diarrhea, blood count changes increasing infection risk, liver and kidney issues. Allergic reactions are possible too.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My kidney function is within the normal range required.

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My advanced lung cancer has a KRAS mutation and standard treatments have failed.

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My cancer has spread, standard treatments failed, and no other treatments are suitable.

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My blood tests show enough white blood cells and platelets.

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My liver tests are within the required range.

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I am able to get out of my bed or chair and move around.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 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

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

Additional pharmacokinetic parameters for siRNA

Best Overall Response per RECIST 1.1

Pharmacokinetic parameters for siRNA

Other outcome measures

To evaluate correlation between KRAS mutations and clinical outcome

To evaluate correlation between biomarkers and clinical outcome

Trial Design

1Treatment groups

Experimental Treatment

Group I: NBF-006Experimental Treatment1 Intervention

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

Nitto BioPharma, Inc.Lead Sponsor

Media Library

Non-Small Cell Lung Cancer Research Study Groups: NBF-006

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals are involved in the current research project?

"Affirmative. According to clinicaltrials.gov, this study is in the process of finding suitable individuals for enrollment; it was initially posted on March 18th 2019 and was most recently revised on December 21st 2021. The research necessitates 44 participants dispersed throughout 10 medical sites."

Answered by AI

Is this investigation still accepting enrollees?

"According to clinicaltrials.gov, recruitment for this trial is ongoing, having been initiated on the 18th of March in 2019 and last updated on the 21st of December 2021."

Answered by AI

Is NBF-006 capable of causing harm to the people who take it?

"Since the available clinical evidence for NBF-006 is limited, our team rated its safety at a 1 on a 3 point scale."

Answered by AI

To what extent is this study being conducted in various locations?

"A number of locations are currently admitting patients into this medical study, including the University of Toledo, Eleanor N. Dana Cancer Center in Toledo, Ohio; Vanderbilt-Ingram Cancer Centre in Nashville, Tennessee; and NEXT Oncology - Austin in Austin Virginia amongst 10 other sites."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2019. "A Study of NBF-006 in Non-Small Cell Lung, Pancreatic, or Colorectal Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03819387.

All > Colorectal Cancer San Diego