Study of ICP-723 in Patients with Advanced Solid Tumors or Primary Central Nervous System Tumors
Phase 1
Recruiting
- Conditions
- Primary Central Nervous System Tumors Harboring NTRK FusionAdvanced Solid Tumors Harboring NTRK Fusion
- Interventions
- Registration Number
- NCT05745623
- Lead Sponsor
- Beijing InnoCare Pharma Tech Co., Ltd.
- Brief 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 55
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description ICP-723 ICP-723 -
- Primary Outcome Measures
Name Time Method Objective response rate (ORR) Through study completion, an average of 4 years The objective response rate (ORR) evaluated by the Independent Center Review
- Secondary Outcome Measures
Name Time Method Time to response (TTR) as assessed by the investigator and the IRC Through study completion, an average of 4 years The incidence, character and severity of adverse events as assessed per NCI-CTCAE v5.0 criteria Through study completion, an average of 4 years ORR assessed by the investigator Through study completion, an average of 4 years DCR as assessed by the investigator and the IRC Through study completion, an average of 4 years Time of maximum observed plasma concentration (Tmax) Through study completion, an average of 4 years AUC0-t Through study completion, an average of 4 years Progression-free survival (PFS) as assessed by the investigator and the IRC Through study completion, an average of 4 years central nervous system progression-free survival (CNS-PFS) as assessed by the investigator and IRC Through study completion, an average of 4 years Overall survival (OS) Through study completion, an average of 4 years Elimination half-life (t1/2) Through study completion, an average of 4 years Apparent clearance (CL/F) Through study completion, an average of 4 years Duration of response (DOR) as assessed by the investigator and the IRC Through study completion, an average of 4 years Intracranial objective response rate (IC-ORR) as assessed by the investigator and IRC Through study completion, an average of 4 years AUC0-∞ Through study completion, an average of 4 years Apparent volume of distribution (Vz/F) Through study completion, an average of 4 years The maximum plasma concentration observed (Cmax) Through study completion, an average of 4 years
Trial Locations
- Locations (1)
Sun Yat-Sen University Cancer Center
🇨🇳Guangzhou, Guangdong, China