RecruitingPhase 1Phase 2NCT05745623
Study of ICP-723 in Patients With Advanced Solid Tumors or Primary Central Nervous System Tumors
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
Sponsor
Beijing InnoCare Pharma Tech Co., Ltd.
Enrollment
70 participants
Start Date
Dec 27, 2022
Study Type
INTERVENTIONAL
Conditions
Summary
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
Min Age: 2 Years
Inclusion Criteria4
- 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 Criteria5
- 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
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Interventions
DRUGICP-723
ICP-723 tablet administered orally，once a day，for every 28 days as one cycle
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05745623