An Open Label, Dose-Escalation, Phase 1/2 Study to Evaluate the Safety, Tolerability, Preliminary Efficacy and Pharmacokinetics of TAK-981 in Adult Patients With Advanced or Metastatic Solid Tumors or Relapsed/Refractory Hematologic Malignancies

This study is in 2 parts.The main aims of the 1st part of the study are to check if people with advanced solid tumors or cancers in the immune system (lymphomas) have side effects from TAK-981, and to check how much TAK-981 they can receive without getting side effects from it.The main aims of the 2nd part of the study are to learn if the condition of people with specific cancers improves after treatment with TAK-981. Another aim is to check for side effects from TAK-981.In the 1st part of the study, participants will receive TAK-981. In the 2nd part of the study, participants with specific tumor types will receive TAK-981 at the recommended phase 2 dose determined during the 1st part of the study.In both parts of the study, participants can receive TAK-981 for up to 1 year or longer if their condition stays improved. Participants will receive TAK-981 through vein.

本研究分为两个部分。第一部分的主要研究目的为：验证晚期实体瘤（advanced solid tumors）或免疫系统恶性肿瘤（淋巴瘤，lymphomas）患者使用TAK-981后是否会出现不良反应，并明确患者可安全耐受的最大给药剂量。第二部分的主要研究目的为：评估特定癌症患者接受TAK-981治疗后病情是否得到改善；另一研究目的为监测TAK-981的不良反应。第一部分中，受试者将接受TAK-981治疗。第二部分中，携带特定肿瘤类型的受试者将接受基于第一部分确定的II期推荐给药剂量（recommended phase 2 dose）的TAK-981治疗。在本研究的两个部分中，若受试者病情持续改善，其接受TAK-981治疗的时长最多可达1年，可视情况适当延长。受试者将经静脉途径接受TAK-981给药。