Advanced Solid Tumors Harboring NTRK Fusion, Primary Central Nervous System Tumors Harboring NTRK Fusion
Conditions
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
Interventions
DRUGICP-723
ICP-723 tablet administered orally，once a day，for every 28 days as one cycle
Sponsors
Beijing InnoCare Pharma Tech Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1; 2. 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; 3. 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. 4. Organ functions meet the clinical criteria
Exclusion criteria
1. Patients with unstable primary central nervous system (CNS) tumors or CNS metastasis. 2. Patients with abnormal QTc interval at screening, or other clinically significant abnormalities in electrocardiographic examination at the discretion of the investigator. 3. Patient with recent anti-tumor and other treatment as stated in the protocol. 4. Grade 1 or higher toxicities attributed to any previous treatment not yet recovered. 5. Other conditions considered unsuitable for participation in this trial at the discretion of the investigator
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective response rate (ORR) | Through study completion, an average of 4 years | The objective response rate (ORR) evaluated by the Independent Center Review |
Secondary
| Measure | Time frame |
|---|---|
| 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 to response (TTR) as assessed by the investigator and the IRC | 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 |
| Progression-free survival (PFS) 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 |
| 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 |
| The maximum plasma concentration observed (Cmax) | Through study completion, an average of 4 years |
| Time of maximum observed plasma concentration (Tmax) | Through study completion, an average of 4 years |
| Elimination half-life (t1/2) | Through study completion, an average of 4 years |
| AUC0-∞ | Through study completion, an average of 4 years |
| AUC0-t | Through study completion, an average of 4 years |
| Apparent clearance (CL/F) | Through study completion, an average of 4 years |
| Apparent volume of distribution (Vz/F) | 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 |
Other
| Measure | Time frame |
|---|---|
| Colony-stimulating factor (CSF) concentrations | Through study completion, an average of 4 years |
Countries
China
Contacts
Primary ContactRuihua Xu
Backup ContactYuhong Li
Outcome results
None listed