1. Modify study population (delete Notch activated endocrine refractory breast cancer). Rationale: Per FDA suggestion, this population may be included in the future once there is sufficient data on the response of subjects with TNBC. 2. Add a lead-in cohort with 6 subjects at dose level 6 mg QW and modify sample size. Rationale: Per FDA request, as a safety precaution, to allow safety evaluation of 6 mg QW in 6 subjects before proceeding to enroll the rest of the subjects. 3. Add PK assessment per FDA request. 4.Replace triglyceride with complete lipid panel as a safety precaution.

1. Delete reference to ‘Early Discontinuation’. In this study end of study and early discontinuation are synonymous. 2. Update exclusion criterion 11f (creatinine) -creatinine clearance (CrCl) <50 mL/min (calculation of CrCl will be based on acceptable institution standard). Rationale: Allow inclusion based on normal creatinine values, as well as sufficient GFR, as AL101 is not expected to impact renal function. 3. Introduce change in regimen (2 weeks on / 1 week of) for first episode of Grade 2 or 3 diarrhea and Grade 2 Colitis before dose reduction on subsequent episodes. Rationale: To allow investigators to use a 2 weeks on 1 weeks off regime at 6 mg QW, before implementing dose reduction. The aim is to introduce a scheduled dose interruption to prevent recurrence of toxicity.