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
This is an open-label, non-controlled study conducted in two parts - Part A (dose escalation) followed by Part B (dose expansion).
Part A (Dose escalation)
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).
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.
To evaluate correlation between biomarkers and clinical outcome.
To evaluate correlation between KRAS mutations and clinical outcome.
Part B (Dose expansion)
To evaluate preliminary efficacy and safety profile of NBF-006 in patients with KRAS-mutated NSCLC.
To investigate the PK of NBF-006.
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.
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.
Prior radiation therapy within 2 weeks or prior chemotherapy non-cytotoxic therapy within 4 weeks or 5 drug half-lives, whichever is shorter (exception: 6 weeks for nitrosourceas or mitomycin C); 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
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