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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ICP-033 Dose Escalation | Experimental | Drug: ICP-033 tablet Administered orally,once a day,every 28 days is a cycle. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ICP-033 tablet | Drug | Administered orally, once a day, 28 days per cycle |
|
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Feng Bi | Contact | +86 028-85423203 | bifeng@medmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Feng Bi | West China Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West China Hospital of Sichuan University | Recruiting | Sichuan | Chengdu | 610041 | China |
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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 |