Tianjin Xinyi Shangde Biomedical Technology Co., Ltd.

Primary objectives: To evaluate the tumor remission and safety of ACT001 combined with radiotherapy in newly diagnosed DIPG subjects (efficacy exploration phase), and to verify the effect of ACT001 combined with radiotherapy on tumor remission and overall survival time in newly diagnosed DIPG subjects (efficacy verification phase); Secondary objectives: To evaluate the efficacy of ACT001 combined with radiotherapy in newly diagnosed DIPG subjects (efficacy exploration phase), to verify other efficacy of ACT001 combined with radiotherapy in newly diagnosed DIPG subjects, and to verify the safety of ACT001 combined with radiotherapy in newly diagnosed DIPG subjects (efficacy verification phase); Exploratory objectives: To evaluate the impact of treatment on biomarkers and its relationship with efficacy, to characterize the PK characteristics of ACT001 and metabolites based on PopPK analysis methods, and to explore the relationship between exposure and effect of ACT001

Primary objective: To evaluate the efficacy of ACT001 combined with whole brain radiotherapy for intracranial tumors in patients with brain metastases from lung cancer. Secondary objectives: To evaluate the efficacy of ACT001 combined with whole brain radiotherapy for intracranial and extracranial tumors in patients with brain metastases from lung cancer using other efficacy endpoints; To evaluate the effect of ACT001 in reducing the toxic and side effects of whole brain radiotherapy; To evaluate the effect of ACT001 on the quality of life of patients with brain metastases from lung cancer; To evaluate the pharmacokinetic (PK) characteristics of ACT001 in the study population. Exploratory objectives: To evaluate the efficacy of ACT001 combined with whole brain radiotherapy in the treatment of intracranial and extracranial tumors in patients with brain metastases from lung cancer; To characterize the PK characteristics of ACT001 based on the population pharmacokinetic (PopPK) analysis method; To evaluate the changes in therapeutic blood biomarkers and their relationship with efficacy; To explore the relationship between exposure and effect of ACT001.

Primary purpose: To evaluate the safety and clinical efficacy of oral administration of different doses of ACT001 capsules combined with radiotherapy in subjects with solid tumor brain metastases; Secondary purpose: None Exploratory purpose: To explore the changes in biomarkers after administration of ACT001 capsules