Evaluation of AP-002 in Patients With Solid Tumors

Inclusion Criteria

• •1. Phase 1: Patients with advanced or recurrent solid tumors with target (± non-target) or with only non-target disease, for which there is no standard therapy available Phase 2: Patients with advanced or recurrent breast cancer, NSCLC, or prostate cancer with target (± non-target) or with only non-target disease for which there is no standard therapy available
• •2. Patients with bone metastases but without target disease are eligible
• •3. Patients with bone metastases must have at least one bone lesion that has not received radiation therapy within 6 weeks prior to Cycle 1 Day 1
• •4. Patients must discontinue bisphosphonate and/or denosumab treatment.
• •5. Age ≥ 18 years
• •6. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
• •7. O2 saturation ≥ 92% on room air per pulse oximetry
• •8. Exhaled nitrous oxide ≤ 50 parts per billion (ppb)
• •9. Adequate hematologic, hepatic and renal function defined as:
• •1. Hemoglobin ≥ 9 g/dL
• •2. Absolute neutrophil count (ANC) ≥ 1.5 × 109/L
• •3. Platelet count ≥ 75 × 109/L
• •4. Total bilirubin ≤ 2 × upper limit of normal (ULN). Patients with an established diagnosis of Gilberts syndrome with an unconjugated bilirubin ≤ 2 mg/dL and conjugated bilirubin within normal limits (WNL) are eligible.
• •5. Serum electrolytes WNL
• •6. Transaminases ≤ 3 × ULN
• •7. Prothrombin time (PT)/international normalized ratio (INR), thromboplastin time (PTT), or activated PTT (aPTT) ≤ 1.5 × ULN. For patients on therapeutic coumadin, PT (INR) ≤ 2.5 × ULN is acceptable; for patients on therapeutic heparin, PTT (or aPTT) ≤ 2.5 × ULN
• •8. Corrected creatinine clearance ≥ 40 mL/minute, based on the Cockcroft-Gault equation
• •10. Patient must have discontinued prior antineoplastic therapy at least 21 days prior to Cycle 1 Day 1 and have recovered or stabilized from any prior AEs related to the prior therapy
• •11. Provision of signed and dated informed consent form
• •12. Serum 25-hydroxyvitamin D ≥ 30 ng/mL by investigative site laboratory at screening