A Multi-center, Non-Randomized, Open-Label Phase 2 Basket Clinical Trial to Evaluate ICP-723 in Patients with Advanced Solid Tumors or Primary Central Nervous System Tumors
Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;
Patients with advanced solid tumors or primary central nervous system (CNS) tumors harboring NTRK gene fusions as detected by the designated central laboratory, who received no previous NTRK inhibitor treatment;
At least one measurable lesion as per RECIST1.1 criteria, or for primary CNS tumors, at least one measurable lesion as per RANO or INRC criteria.
Organ functions meet the clinical criteria
Patients with unstable primary central nervous system (CNS) tumors or CNS metastasis.
Patients with abnormal QTc interval at screening, or other clinically significant abnormalities in electrocardiographic examination at the discretion of the investigator.
Patient with recent anti-tumor and other treatment as stated in the protocol.
Grade 1 or higher toxicities attributed to any previous treatment not yet recovered.
Single group
ICP-723
DrugICP-723 tablet administered orally，once a day，for every 28 days as one cycle
Objective response rate (ORR)
The objective response rate (ORR) evaluated by the Independent Center Review
ORR assessed by the investigator
DCR as assessed by the investigator and the IRC
Time to response (TTR) as assessed by the investigator and the IRC
Duration of response (DOR) as assessed by the investigator and the IRC
Colony-stimulating factor (CSF) concentrations
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