Evaluate the Safety, Tolerability, and Pharmacokinetics of ICP-723 in Patients With Advanced Solid Tumors

Study Overview
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Brief Summary
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During this study, dose escalation will be conducted in subjects with advanced solid tumors who have experienced treatment failure after clinical standard of care treatments or who currently have no effective treatment available to evaluate the safety, tolerability, and PK of ICP-723

Official Title
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A Multicenter, Open-Label Phase I Clinical Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of ICP-723 in Patients With Advanced Solid Tumors

Conditions
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Advanced Solid Tumors

Intervention / Treatment
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* Drug: ICP-723


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with histopathologically confirmed locally advanced malignant solid tumors that are unresectable or metastatic and that are unresponsive to standard treatments or have relapsed; patients who have progressed under standard treatment including prior treatment with TRK or ROS1 inhibitors. Male or female patients with age ≥18 years old and ≤80 years old. Measurable lesion according to RECIST 1.1. Adequate organ functions that meet protocol requirement criteria. Patients with asymptomatic, stable primary central nervous system (CNS) tumors or CNS metastases (treated or untreated) Participates voluntarily, signs informed consent, and follows the study treatment plan and scheduled visits. Exclusion Criteria: Other than the advanced malignant solid tumor under study, patients with another one or more active malignancies within the previous 5 years except for locally curable cancers that have been apparently cured Received systemic anti-cancer therapy including chemotherapy (except for oral fluorouracil chemotherapy), radiation therapy, hormones, targeted drugs, or biological immunotherapy within 4 weeks or 5 half-lives Major surgery (thoracotomy, laparotomy, etc.) within 4 weeks or minor surgery (superficial skin surgery, lymphadenectomy, hernia repair, etc.) within 2 weeks before the first dose of the study drug Clinically significant gastrointestinal/neurological dysfunction that may affect drug intake, transport, or absorption. Has evidence of uncontrolled heart disease At the investigator's discretion, evidence of severe or uncontrolled systemic disease. Other conditions considered by the investigator to be inappropriate for participation in this study.

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: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ICP-723<br> | Drug: ICP-723<br>* 3+3 dose escalation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence and severity of dose-limiting toxicity (DLT), adverse events (AEs), and serious adverse events (SAEs). Frequency of dose interruptions, reductions and intensity |  | through study completion, an average of 1.5 years. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective response rate (ORR) determined using RECIST 1.1 criteria. |  | Through study completion, an average of 4 years | 
| Disease control rate (DCR) determined using RECIST 1.1 criteria. |  | Through study completion, an average of 4 years | 
| Peak concentration (Cmax) |  | Through study completion, an average of 4 years | 
| Time to reach peak concentration (Tmax) |  | Through study completion, an average of 4 years | 
| Half-life (t1/2) |  | Through study completion, an average of 4 years | 
| Area under the plasma concentration-time curve (AUC0-∞ and 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 |