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

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.
• •10. 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.
• •11. All patients must have measurable tumor per RECIST 1.1.
• •12. Agree to adhere to all study protocol requirements.