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A Study of NBF-006 in Non-Small Cell Lung, Pancreatic, or Colorectal Cancer | Clinical Trials | Clareo Health

COMPLETEDPHASE1

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

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

NCT03819387•Nitto BioPharma, Inc.

View on ClinicalTrials.gov

Summary

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

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.
+3 more criteria

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.
+9 more criteria

Locations (9)

Beverly Hills Cancer Center

Beverly Hills, California, United States

UC San Diego Moores Cancer Center

La Jolla, California, United States

Moffitt Cancer Center

Tampa, Florida, United States

University of Toledo, Eleanor N. Dana Cancer Center

Toledo, Ohio, United States

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, United States

NEXT Oncology - Austin

Austin, Texas, United States

Mary Crowley Cancer Research Center

Dallas, Texas, United States

NEXT Oncology - San Antonio

San Antonio, Texas, United States

NEXT Oncology - Virginia

Fairfax, Virginia, United States

Key Dates

Start Date

March 18, 2019

Primary Completion Date

November 2, 2023

Completion Date

March 12, 2024

Last Updated

July 24, 2024

Enrollment

ACTUAL participants

Conditions

Non-Small Cell Lung CancerPancreatic CancerColorectal Cancer

Interventions

NBF-006

DRUG

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NCT05053971

Advanced Malignant Solid NeoplasmLocally Advanced Pancreatic Carcinoma+7 more

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RECRUITINGPHASE3

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 24, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Testing A New Anti-cancer Drug Combination, Entinostat and ZEN003694, for Advanced and Refractory Solid Tumors

Sacituzumab Tirumotecan (MK-2870) Versus Pemetrexed and Carboplatin Combination Therapy in Participants With Epidermal Growth Factor (EGFR)-Mutated, Advanced Nonsquamous Non-small Cell Lung Cancer (NSCLC) Who Have Progressed on Prior EGFR Tyrosine Kinase Inhibitors (MK-2870-009)

A Clinical Study of Calderasib (MK-1084) and Other Treatments for Participants With Non-Small Cell Lung Cancer (MK-1084-007/KANDLELIT-007)

Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations

Testing the Combination of Two Anti-cancer Drugs, DS-8201a and AZD6738, for The Treatment of Advanced Solid Tumors Expressing the HER2 Protein or Gene, The DASH Trial

Clinical Trial of an Anti-cancer Drug, CA-4948 (Emavusertib), in Combination With Chemotherapy Treatment (FOLFOX Plus Bevacizumab) in Metastatic Colorectal Cancer