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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 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

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Non-Small Cell Lung Cancer (NSCLC) include chemotherapy, targeted therapy, and immunotherapy. Chemotherapy kills rapidly dividing cells, including cancer cells, but can also affect normal cells, leading to side effects. Targeted therapies, such as tyrosine kinase inhibitors (TKIs), focus on specific genetic mutations or proteins that drive cancer growth, offering a more precise treatment with potentially fewer side effects. Immunotherapy, including immune checkpoint inhibitors like anti-PD-1 and anti-PD-L1 antibodies, boosts the body's immune response against cancer cells. These treatments are vital for NSCLC patients as they provide multiple strategies to control and potentially eliminate the cancer, thereby improving survival rates and quality of life.
Large Cell Neuro-Endocrine Carcinoma of the Lung: Current Treatment Options and Potential Future Opportunities.Management of patients with lung cancer and poor performance status.Systemic therapy for lung cancer brain metastases: a rationale for clinical trials.

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
~7 spots leftby Jun 2025
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