{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"13"},{"groupId":"OG001","value":"4"}],"units":"Participants"}],"description":"The outcome measure presented is the number of DLTs per module","groups":[{"description":"This Module is designed to evaluate the tolerability and the overall safety profile of NUC-3373 (1875 mg/m2) + LV (400 mg/m2) + pembrolizumab (200 mg) in the treatment of patients with advanced solid tumours (dose validation phase).\n\nNUC-3373 and LV will be administered on Days 1, 8 and 15 and pembrolizumab will be administered on Day 1 of 21-day cycles. The dosing schedule may be adjusted based on emerging data with agreement from the Safety Review Committee. Following completion of the dose validation phase, expansion cohorts may be initiated at the selected dose level.","id":"OG000","title":"Module 1 (NUC-3373 + LV + Pembrolizumab)"},{"description":"This Module is designed to assess NUC-3373 (750 mg/m2) + LV (400 mg/m2) + docetaxel (55 mg/m2) for the treatment of patients with advanced/metastatic NSCLC or pleural mesothelioma who have progressed on, or were unable to tolerate, 1 or 2 prior lines of cytotoxic chemotherapy-containing regimens for advanced/metastatic disease (dose validation phase).\n\nNUC-3373 and LV will be administered on Days 1 and 22 and docetaxel will be administered on Day 8 of 28-day cycles. The dosing schedule may be adjusted based on emerging data with agreement from the Safety Review Committee. Following completion of the dose validation phase, expansion cohorts may be initiated at the selected dose level.","id":"OG001","title":"Module 2 (NUC-3373 + LV + Docetaxel)"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"The safety population was used and consisted of all patients who received at least one dose of study treatment (n=13 in Module 1 and n=4 in Module 2).","reportingStatus":"POSTED","timeFrame":"Assessed during Cycle 1 (first 28 days) in Module 1 and during Cycles 1 and 2 (first 56 days) in Module 2","title":"Number of Participants With DLTs in Each Module","type":"PRIMARY","unitOfMeasure":"Participants"}