Study procedures and assessments
death, DLTs, tumour
DISEASE PROGRESSION, EVENT, ADVERSE EVENT, TUMOUR
The study consisted of a 4-week screening period, a 6- to 10-month treatment period (plus up to an extra 6 months in part B), and an ongoing 5-year long-term follow-up (Fig. Overview of study procedures during part A and part B of the study. After each [Eight weeks after the third treatment administration, an EOCT visit took place, which included repetition of baseline analyses. In the event that patients in part B underwent additional treatment cycles, a further assessment (EOAC visit) was performed 8 weeks after the last administration of [Radiological assessments for tumour response were performed at screening, at the end of each treatment cycle, and at the EOCT visit (or at the EOAC/early withdrawal visit), through independent central review on CT/MRI, according to RECIST version 1.1. Long-term follow-up is ongoing, in which tumour response assessments and safety evaluations will be carried out over 5 years or until disease progression or death.Safety outcome measures included the nature, frequency, severity, and timing of treatment-emergent AEs (TEAEs), including dose-limiting AEs and AEs leading to treatment modification or withdrawal. AEs were graded using Common Terminology Criteria for Adverse Events version 5.0, and the relationship to [In part A, if DLTs occurred in two or fewer of the initial six patients, the remaining nine patients would continue at the administered activity. In part B, based on the first three evaluable patients in each cohort, if DLTs occurred in more than one patient, the next cohort would not be initiated. If DLTs occurred in no more than one of the patients, and two or more of the three patients had a cumulative absorbed dose in each organ-at-risk exceeding the acceptability limits (1.5 Gy in the bone marrow and 23 Gy in the kidney), patients in the next cohort would receive the same cumulative activity or less than the preceding cohort. If DLTs occurred in no more than one of the patients, and fewer than two of the three patients did not reach the cumulative absorbed dose limit in each organ-at-risk, the next cohort would be initiated as planned.