A Study of ICP-033 in Patients With Advanced Solid Tumors

Study Overview
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Brief Summary
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A Dose finding Study to Evaluate the Safety, Tolerability and Pharmacokinetics and Preliminary Anti-Tumor Activity of ICP-033 Tablets in Patients with Advanced Solid Tumors.

Official Title
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A Phase I Clinical Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of ICP-033 in Patients With Solid Tumors

Conditions
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Patients With Advanced Solid Tumors

Intervention / Treatment
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* Drug: ICP-033 tablet


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 histologically confirmed locally advanced unresectable or metastatic solid tumors; At least one measurable lesion according to RECIST 1.1. Exclusion Criteria: Pregnant and lactating women, or women planning to become pregnant during the study through at least 6 months after the last dose of study drug. Patients with unstable primary central nervous system (CNS) tumors or CNS metastases. Patients who have active or history of interstitial lung disease or noninfectious pneumonia. Patients with QTc > 450 ms in males and > 470 ms in females on ECG at screening, or other clinically significant abnormalities in the ECG at the discretion of the investigator. Patient with the Medication history and surgical history as stated in the protocol Those who are unsuitable for blood collection or contraindicated for blood collection. 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
Maximum Age: 75 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-033 Dose Escalation<br>Drug: ICP-033 tablet Administered orally，once a day，every 28 days is a cycle. | Drug: ICP-033 tablet<br>* Administered orally, once a day, 28 days per cycle<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence and severity of adverse event (AE) of ICP-033 assessed by NCI-CTCAE V5.0. | To assess the safety and tolerability of ICP-033 in patients with advanced solid tumors. | through study completion, an average of 2 years | 
| Dose-Limiting Toxicities (DLTs) | To assess the safety and tolerability of ICP-033 in patients with advanced solid tumors. | through study completion, an average of 2 years | 
| Maximum tolerated dose (MTD) | To assess the safety and tolerability of ICP-033 in patients with advanced solid tumors. | through study completion, an average of 2 years | 
| Recommended phase II dose (RP2D) |  | through study completion, an average of 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The maximum plasma concentration observed (Cmax) | To evaluate the pharmacokinetic (PK) characteristics of ICP-033 in patients with solid tumors. | through study completion, an average of 2 years | 
| Time of maximum observed plasma concentration (Tmax) | To evaluate the pharmacokinetic (PK) characteristics of ICP-033 in patients with solid tumors. | through study completion, an average of 2 years | 
| Elimination half-life (t1/2) | To evaluate the pharmacokinetic (PK) characteristics of ICP-033 in patients with solid tumors. | through study completion, an average of 2 years | 
| Area under plasma concentration-time curve (AUC0-t and AUC0-∞) | To evaluate the pharmacokinetic (PK) characteristics of ICP-033 in patients with solid tumors. | through study completion, an average of 2 years | 
| Apparent clearance (CL/F) | To evaluate the pharmacokinetic (PK) characteristics of ICP-033 in patients with solid tumors. | through study completion, an average of 2 years | 
| Apparent volume of distribution (Vz/F) | To evaluate the pharmacokinetic (PK) characteristics of ICP-033 in patients with solid tumors. | through study completion, an average of 2 years | 
| The objective response rate (ORR) | To evaluate the preliminary anti-tumor activity of ICP-033. | through study completion, an average of 2 years | 
| Duration of response (DoR) | To evaluate the preliminary anti-tumor activity of ICP-033. | through study completion, an average of 2 years | 
| Progression-free survival (PFS) | To evaluate the preliminary anti-tumor activity of ICP-033. | through study completion, an average of 2 years | 
| Overall survival (OS) | To evaluate the preliminary anti-tumor activity of ICP-033. | through study completion, an average of 2 years |