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Clinical Trial 21157

Cancer Type: Thoracic
Study Type: Treatment
NCT#: NCT03819387

Phase: Phase I
Prinicipal Investigator: Chiappori, Alberto

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Overview

Study 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

Summary

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

Objective

Objectives: Part A (Dose escalation) Primary: To determine the safety profile, maximum tolerated dose (MTD), and recommended dose of NBF-006 for Part B in patients with advanced non-small cell lung cancer (NSCLC), pancreatic, or colorectal cancer for dose levels 1-4 (0.15, 0.3, 0.6, and 1.2 mg/kg) and in patients with Kirsten rat sarcoma (KRAS)-mutated NSCLC for dose level 5 (1.6 mg/kg). Secondary: To evaluate preliminary efficacy of NBF-006 in patients with advanced NSCLC, pancreatic, or colorectal cancer for dose levels 1-4 (0.15, 0.3, 0.6, and 1.2 mg/kg) and in patients with KRAS-mutated NSCLC for dose level 5 (1.6 mg/kg). To investigate the pharmacokinetics (PK) of NBF-006. Exploratory: To evaluate correlation between biomarkers and clinical outcome. To evaluate correlation between KRAS mutations and clinical outcome. Part B (Dose expansion) Primary: To evaluate preliminary efficacy and safety profile of NBF-006 in patients with KRAS-mutated NSCLC. Secondary: To investigate the PK of NBF-006. Exploratory: To evaluate correlation between glutathione S-transferase pi (GSTP) messenger ribonucleic acid (mRNA) knockdown (KD) in surrogate tissue (peripheral blood mononuclear cells [PBMCs]), biomarkers, and clinical outcome.

Treatments

Therapies

Therapy (NOS)

Medications

NBF-006 ()

Inclusion Criteria

  • 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 > Adequate bone marrow function, defined per protocol
  • Adequate renal function, defined per protocol
  • Adequate hepatic function, defined per protocol
  • 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.

  • Exclusion Criteria

  • 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
  • Known history of human immunodeficiency virus or active infection with hepatitis B virus or hepatitis C virus.
  • Known uncontrolled intercurrent illnesses, including uncontrolled viral influenza and COVID 19, systemic bacterial infections, and fungal infections.
  • Psychiatric disorder or altered mental status that would preclude understanding of the informed consent process and/or completion of the necessary studies.
  • Known allergic reactions to H1/H2 antagonists.

  • If you are interested in learning more about clinical trials, our clinical trial navigators can discuss your options and recommend opportunities that may be suitable for you. Call 813-745-6100 or 1-800-679-0775 (toll-free) or submit a clinical trials inquiry form.