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A Dose finding Study to Evaluate the Safety, Tolerability and Pharmacokinetics and Preliminary Anti-Tumor Activity of ICP-189 Tablets and ICP-189 Tablets in Combination with Anti-PD-1 Monoclonal Antibody in Patients with Advanced Solid Tumors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase Ia: ICP-189 Dose Escalation | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ICP-189 | Drug | Administered orally |
|
| Measure | Description | Time Frame |
|---|---|---|
| The incidence and severity of adverse event (AE) of ICP-189 assessed by NCI-CTCAE V5.0 | To assess the safety and tolerability of ICP-189 in patients with advanced solid tumors. | through study completion, an average of 2 years |
| Dose-Limiting Toxicities (DLTs) | Percentage of Participants Experiencing Dose Limiting Toxicities (DLTs). | through study completion, an average of 2 years |
| Recommended Phase 2 Dose (RP2D) and/or maximum tolerated dose (MTD) | To preliminarily determine the PR2D and the MTD of ICP-189 in patients with advanced solid tumors | 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-189 in patients with solid tumors. | through study completion, an average of 2 years |
| Time of maximum observed plasma concentration (Tmax) |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacodynamics | On-treatment versus baseline comparison of PD biomarkers e.g., phosphorylated form of extracellular signal-regulated kinase (pERK), dual specificity phosphatase 6 (DUSP6). | through study completion, an average of 2 years |
Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria apply.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Caicun Zhou | Contact | +86 13301825532 | caicunzhoudr@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Caicun Zhou | Shanghai Pulmonary Hospital, Shanghai, China | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Pulmonary Hospital | Shanghai | Shanghai Municipality | 200433 | China |
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To evaluate the pharmacokinetic (PK) characteristics of ICP-189 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-189 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-189 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-189 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-189 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-189. | through study completion, an average of 2 years |
| Duration of response (DoR) | To evaluate the preliminary anti-tumor activity of ICP-189. | through study completion, an average of 2 years |
| Progression-free survival (PFS) | To evaluate the preliminary anti-tumor activity of ICP-189. | through study completion, an average of 2 years |
| Overall survival (OS) | To evaluate the preliminary anti-tumor activity of ICP-189. | through study completion, an average of 3.5 years |