Patients With Advanced Solid Tumors
Conditions
Brief summary
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.
Interventions
DRUGICP-189
Administered orally
Sponsors
Beijing InnoCare Pharma Tech Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1; 2. Patients with histologically confirmed locally advanced unresectable or metastatic solid tumors; 3. At least one measurable lesion according to RECIST 1.1.
Exclusion criteria
1. Patients who have had other cancer(s) within 5 years prior to the first dose, except for locally curable cancers that have been apparently cured; 2. Patients with unstable primary central nervous system (CNS) tumors or CNS metastases; 3. Patients who have an active autoimmune disease or have had an autoimmune disease with risk of recurrence; 4. Patients who have active or history of interstitial lung disease or non-infectious pneumonia; 5. Patients who have a history of severe allergic reaction to any component of ICP-189 tablets or anti-PD-1 antibody (\> grade 3 assessed by CTCAE 5.0). Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recommended Phase 2 Dose (RP2D) and/or maximum tolerated dose (MTD) | through study completion, an average of 2 years | To preliminarily determine the PR2D and the MTD of ICP-189 in patients with advanced solid tumors |
| The incidence and severity of adverse event (AE) of ICP-189 assessed by NCI-CTCAE V5.0 | through study completion, an average of 2 years | To assess the safety and tolerability of ICP-189 in patients with advanced solid tumors. |
| Dose-Limiting Toxicities (DLTs) | through study completion, an average of 2 years | Percentage of Participants Experiencing Dose Limiting Toxicities (DLTs). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Elimination half-life (t1/2) | through study completion, an average of 2 years | To evaluate the pharmacokinetic (PK) characteristics of ICP-189 in patients with solid tumors. |
| Area under plasma concentration-time curve (AUC0-t and AUC0-∞) | through study completion, an average of 2 years | To evaluate the pharmacokinetic (PK) characteristics of ICP-189 in patients with solid tumors. |
| Apparent clearance (CL/F) | through study completion, an average of 2 years | To evaluate the pharmacokinetic (PK) characteristics of ICP-189 in patients with solid tumors. |
| Apparent volume of distribution (Vz/F) | through study completion, an average of 2 years | To evaluate the pharmacokinetic (PK) characteristics of ICP-189 in patients with solid tumors. |
| Duration of response (DoR) | through study completion, an average of 2 years | To evaluate the preliminary anti-tumor activity of ICP-189. |
| Progression-free survival (PFS) | through study completion, an average of 2 years | To evaluate the preliminary anti-tumor activity of ICP-189. |
| Overall survival (OS) | through study completion, an average of 3.5 years | To evaluate the preliminary anti-tumor activity of ICP-189. |
| The objective response rate (ORR) | through study completion, an average of 2 years | To evaluate the preliminary anti-tumor activity of ICP-189. |
| The maximum plasma concentration observed (Cmax) | through study completion, an average of 2 years | To evaluate the pharmacokinetic (PK) characteristics of ICP-189 in patients with solid tumors. |
| Time of maximum observed plasma concentration (Tmax) | through study completion, an average of 2 years | To evaluate the pharmacokinetic (PK) characteristics of ICP-189 in patients with solid tumors. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Pharmacodynamics | through study completion, an average of 2 years | On-treatment versus baseline comparison of PD biomarkers e.g., phosphorylated form of extracellular signal-regulated kinase (pERK), dual specificity phosphatase 6 (DUSP6). |
Countries
China
Contacts
Primary ContactCaicun Zhou
Outcome results
None listed