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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
22
Administered orally
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, China
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.
Time frame: through study completion, an average of 2 years
Dose-Limiting Toxicities (DLTs)
Percentage of Participants Experiencing Dose Limiting Toxicities (DLTs).
Time frame: 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
Time frame: through study completion, an average of 2 years
The maximum plasma concentration observed (Cmax)
To evaluate the pharmacokinetic (PK) characteristics of ICP-189 in patients with solid tumors.
Time frame: through study completion, an average of 2 years
Time of maximum observed plasma concentration (Tmax)
To evaluate the pharmacokinetic (PK) characteristics of ICP-189 in patients with solid tumors.
Time frame: 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.
Time frame: 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.
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Time frame: 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.
Time frame: 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.
Time frame: through study completion, an average of 2 years
The objective response rate (ORR)
To evaluate the preliminary anti-tumor activity of ICP-189.
Time frame: through study completion, an average of 2 years
Duration of response (DoR)
To evaluate the preliminary anti-tumor activity of ICP-189.
Time frame: through study completion, an average of 2 years
Progression-free survival (PFS)
To evaluate the preliminary anti-tumor activity of ICP-189.
Time frame: through study completion, an average of 2 years
Overall survival (OS)
To evaluate the preliminary anti-tumor activity of ICP-189.
Time frame: through study completion, an average of 3.5 years