This is a phase 1, open label, dose-escalation, safety, pharmacokinetic, and pharmacodynamic
study to determine the maximum tolerated doses (MTD) or recommended phase 2 doses (RP2D) of
both ALA and RT. Once the MTDs are identified, the cohort providing the highest dose
intensity at or below the MTD (if supported by emerging PK and biomarker data) will be
selected for an expansion phase for the purpose of refining the safety assessment and
assessing preliminary efficacy. The initial dose escalation phase will enroll at least 20
patients across a variety of tumor types, after which concurrent disease site-specific
expansion cohorts will accrue, each consisting of 20 patients. Anatomic site-specific cohorts
will include patients with symptomatic metastatic disease to specific anatomic regions, where
varying toxicity may be expected (Head and Neck, Thorax and Abdomen/Pelvis).