DNA x IL2RA

1、主要目的： （1）评估IBI363联合治疗在晚期恶性肿瘤受试者中的安全性和耐受性； （2）评估IBI363联合治疗在晚期恶性肿瘤受试者中的抗肿瘤活性。 2、次要目的： （1）评估IBI363联合治疗在晚期恶性肿瘤受试者中的药代动力学（Pharmacokinetics, PK）特征； （2）评估IBI363联合治疗在晚期恶性肿瘤受试者中的免疫原性。 3、探索性目的： （1）探索肿瘤组织样本中PD-L1表达水平和肿瘤微环境与疗效的关系。 （2）探索IBI363联合治疗在晚期恶性肿瘤受试者中的药效动力学（Pharmacodynamics, PD）特征。

This phase I trial is to find out the best dose, possible benefits and/or side effects of 90Y-DOTA-anti-CD25 basiliximab given together with fludarabine, melphalan, and total marrow and lymphoid irradiation (TMLI) in treating patients with high-risk acute leukemia or myelodysplastic syndrome. 90Y-DOTA-anti-CD25 basiliximab is a monoclonal antibody, called basiliximab, linked to a radioactive agent called 90Y-DOTA. Basiliximab attaches to CD25 positive cancer cells in a targeted way and delivers 90Y-DOTA to kill them. Fludarabine and melphalan are common chemotherapy drugs used to prepare the bone marrow to receive transplanted cells. TMLI is a different type of targeted radiation therapy used to prepare the bone marrow to receive transplanted cells. Giving 90Y-DOTA-anti-CD25 basiliximab together with fludarabine, melphalan, and TMLI may help prepare the bone marrow to receive the transplanted cells for improved transplant outcomes in patients with acute leukemia or myelodysplastic syndrome.

This is a first-in-human, phase 1a/1b, multicenter, open-label, dose escalation study of STK-012 as monotherapy and in combination therapy in patients with selected advanced solid tumors.