What this trial measures

• Parts 1 and 2: Number of Participants with Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and TEAEs Leading to Treatment DiscontinuationFrom signing of the informed consent up to 30 days after last dose (up to 3 years)
• Part 1: Number of Participants with Dose-Limiting Toxicities (DLTs)Cycle 1 (each cycle is of 21 days)
• Part 2: Clinical Benefit Rateup to 12 weeks

  CBR is defined as the percentage of participants who achieve either an objective tumor response - complete response (CR), partial response (PR) - or confirmed stable disease with an absence of tumor progression during the first 12 weeks. CBR was assessed according to modified Response Evaluation Criteria in Solid Tumors (mRECIST) v1.1. CR: Disappearance of all non-nodal target lesions and reduction in short axis of pathological lymph nodes to less than (\<) 10 millimeter (mm); PR: at least a 30 percent (%) decrease in the sum of diameters of target lesions from baseline; SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progression disease (PD).

• Part 2: Objective Response RateBaseline up to 3 years

  ORR is defined as the percentage of participants who achieve complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 as determined by the Investigator. CR: defined as disappearance of all target and all non-target lesions and no new lesions. PR: defined as at least a 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters, no progression of non-target lesions and no new lesions.