A Study of AL102 in Patients With Progressing Desmoid Tumors

Exclusion Criteria

• •1. Diagnosed with a malignancy in the past 2 years with some exceptions.
• •2. Current or recent (within 2 months of IP administration) GI disease or disorders that increase the risk of diarrhea, such as inflammatory bowel disease and Crohn's disease.
• •3. Evidence of uncontrolled, active infection, requiring systemic anti-bacterial, anti-viral or anti- fungal therapy ≤7 days prior to administration of IP such as known active infection with hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) at Screening.
• •4. Myocardial infarction within 6 months prior to enrollment, greater than Class 1 angina pectoris, or has New York Heart Association (NYHA) Class III or IV heart failure, , symptomatic ventricular arrhythmias, sustained ventricular tachycardia, Torsade's de Pointes (TdP), the long QT syndrome, pacemaker dependence, or electrocardiographic evidence of acute ischemia.
• •5. Unstable or severe uncontrolled medical condition (e.g., unstable cardiac or pulmonary function or uncontrolled diabetes) or any important medical illness or abnormal laboratory finding that would, in the investigator's judgment, increase the risk to the subject associated with his or her participation in the study.
• •6. Pregnant or breastfeeding or expecting to conceive children within the projected duration of the study.
• •7. Eastern Cooperative Oncology Group (ECOG) performance status ≥2
• •8. Abnormal organ and marrow function at Screening defined as:
• •1. Neutrophils \<1000/mm3,
• •2. Platelet count \<100,000/mm3,
• •3. Hemoglobin \<9 g/dL,
• •4. Total bilirubin \>1.5x upper limit of normal (ULN) (except known Gilbert's syndrome),
• •5. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \>2.5x ULN,
• •6. Serum creatinine \> ULN and creatinine clearance (CrCl) \<60 mL/min (calculation of CrCl will be based on acceptable institution standard)
• •7. Uncontrolled triglyceride ≥Grade 2 elevations per common terminology criteria for adverse events (CTCAE) v5.0 (\>300 mg/dL or \>3.42 mmol/L).
• •9. ECG Exclusions (Part A only)
• •1. Mean QT interval corrected for heart rate using Fridericia's formula (QTcF) ≥450 msec.
• •2. QRS duration \> 110 ms
• •3. PR interval \> 240 ms
• •4. Marked ST-T wave abnormalities which would make it difficult to measure the QT interval
• •10. Any treatments for desmoid tumors within 4 weeks prior to first dose of investigational therapy; subject must have recovered from therapy related toxicity to \< CTCAE Grade 2 or clinical baseline. Therapy includes:
• •1. Locoregional tumor directed therapies such as major surgery, radiation, radiofrequency ablation, or cryosurgery
• •2. Systemic therapy including chemotherapy, biologic (anti-neoplastic agent, antibodies), TKIs (e.g., sorafenib, pazopanib, imatinib), hormonal therapy, or investigational therapy
• •11. Chronic NSAIDs for the treatment of desmoid tumors within 4 weeks of first dose of IP;