A Phase I/II Clinical Trial of ICP-723 in the Treatment of Advanced Solid Tumors

Study Overview
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Brief Summary
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A Multicenter, Nonrandomized, Open-Label Phase I/IIClinical Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of ICP-723 in Patients with Solid Tumors

Detailed Description
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Solid Tumors

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

Conditions
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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: Histopathologically confirmed surgically unresectable locally advanced or metastatic solid tumors or primary central nervous system (CNS) tumors.. Age: Adult Cohort: Age ≥ 18 years; Adolescent cohort: 12 ≤ years < 18 years. 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. Adult cohort: ECOG PS score of 0-1; Adolescent cohort: Karnofsky (age ≥ 16 years) or Lansky (age < 16 years) PS score > 60. Life expectancy > 3 months. Female patients or male patients of childbearing potential, who agree to use medically acceptable effective methods of birth control throughout the study up to 12 weeks after the last dose of the study treatment. Patients who have signed the Informed Consent Form voluntarily and agree to follow the therapeutic regimen and the visit schedule. Exclusion Criteria: Any other active malignancy within 5 years prior to the first dose of the study drug. Prior anti-cancer treatment within 28 days prior to the first dose. Major surgical procedures within 4 weeks or minor surgical procedures within 2 weeks prior to the first dose of the study drug. A history of allergic disease, severe drug allergy, known hypersensitivity to any component of the ICP-723 tablet formulation. Other situations that, in the investigator's opinion, would make the subject unsuitable for participation in the study. NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

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>ICP-723 | Drug: ICP-723<br>* ICP-723 is a white, round, uncoated table<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | To evaluate the safety and tolerability of ICP-723 at different doses in the treatment of advanced solid tumors; | Up to 12 months | 
| MTD | To determine maximum tolerated dose (MTD) | Up to 2 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax | To preliminarily obtain pharmacokinetic (PK) data of ICP-723 in the treatment of advanced solid tumors include the peak plasma concentration (Cmax) | Up to 1 month | 
| ORR | Objective Response Rate | Up to 2 months |