A Phase 2 Study of ICP-723 in Patients With Advanced Solid Tumors or Primary Central Nervous System Tumors

Study Overview
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Brief Summary
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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

Official Title
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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

Conditions
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Advanced Solid Tumors Harboring NTRK Fusion, Primary Central Nervous System Tumors Harboring NTRK Fusion

Intervention / Treatment
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* Drug: ICP-723


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ICP-723<br> | Drug: ICP-723<br>* ICP-723 tablet administered orally，once a day，for every 28 days as one cycle<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective response rate (ORR) | The objective response rate (ORR) evaluated by the Independent Center Review | Through study completion, an average of 4 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 incidence, character and severity of adverse events as assessed per NCI-CTCAE v5.0 criteria |  | 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 |