ASP-1929 Photoimmunotherapy (PIT) Study in Recurrent Head/Neck Cancer for Patients Who Have Failed at Least Two Lines of Therapy

ORR, defined by the percentage of patients with the best overall response of complete response (CR) or partial response (PR) by RECIST 1.1 with modifications.

DoR, defined as the time from first objective response (CR or PR) to the date of the first documented tumor progression, as determined by Central Radiographic Review according to RECIST 1.1 criteria with modifications or date of death due to any cause, whichever occurs first.

EFS, defined as the time interval from randomization to a >20% increase in tumor size from baseline (CT or MRI scan at screening) by Central Radiographic Review according to RECIST 1.1 with modifications, development of new locoregional disease, distant metastatic disease, or death, whichever occurs first.

Change from baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30). EORTC QLQ-C30 is a 30-item questionnaire developed to assess QoL of head and neck cancer participants and consists of five functional scales (physical, role, cognitive, emotional, and social), three symptom scales (fatigue, pain, and nausea and vomiting), a global health status scale, and a number of single items assessing additional symptoms commonly reported by cancer patients (dyspnoea, loss of appetite, insomnia, constipation and diarrhea) and perceived financial impact of the disease. It has four-point scales for the first 28 items. The minimum value is 1 and maximum value is 4. Higher scores mean a worse outcome. Overall health was evaluated as a 7-point response scale as the other two questions in that scale. The minimum value is 1 and maximum value is 7. Higher scores mean a better outcome.

Change from baseline in EORTC head and neck specific module (EORTC QLQ H\&N 35). EORTC QLQ-H\&N35 is a 35-item questionnaire developed to assess QoL of head and neck cancer participants and consists of 7 multiple-item scales that assess the symptom of pain, swallowing, senses (taste/smell), speech, social eating, social contact and sexuality. Also, six single-item scales are included to survey the presence of symptomatic problems associated with teeth, mouth=opening, dry mouth, sticky saliva, coughing, and feeling ill. The minimum value is 1 and maximum value is 4. It has 2-point scales for the last 5 items. The minimum value is 1 and maximum value is 2. For all items and scales, high scores indicate more problems.

Change from baseline in EuroQol 5-Dimension 5-Level (EQ 5D-5L) Questionnaire. EQ-5D-5L is a 5-dimension (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) questionnaire developed to assess the patient-generated health state index score from the societal perspective and subjective perceived health. For each dimension, levels of perceived problems are coded from level 1 (minimum) to level 5 (maximum): no problems (1), slight problems (2), moderate problems (3), severe problems (4), and extreme problems/inability (5). A second part of the questionnaire provides a visual analogue scale (VAS) for individually perceived health from 0 to 100 (corresponding to the worst to the best imaginable health).

Estimate covariate effects of ASP-1929 PK through compartmental PK modeling.

CR, defined as the proportion of patients with tumor response of CR, as determined by Central Radiographic Review according to RECIST 1.1 with modifications.

CR by histopathologic biopsy of target tumor(s) and a repeated confirmatory histopathologic CR biopsy at least 3 months after initial CR histopathologic biopsy of the target tumor(s) for patients who demonstrate a clinical CR but not an image CR per RECIST 1.1 with modifications, as determined by the Investigator.