Overview
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
Eligibility
Inclusion Criteria:
- 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
Exclusion 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.
- Other conditions considered unsuitable for participation in this trial at the discretion of the investigator