A Study of ICP-189 and ICP-189 in Combination With Anti-PD-1 Monoclonal Antibody in Patients With Advanced Solid Tumors
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Phase Ia: ICP-189 Dose Escalation
|
Drug: ICP-189
Administered orally
|
Outcome Measures
Primary Outcome Measures
- 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).
- 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
Secondary Outcome Measures
- 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.
- 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.
- The objective response rate (ORR) [through study completion, an average of 2 years]
To evaluate the preliminary anti-tumor activity of ICP-189.
- 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.
Other Outcome Measures
- 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).
Eligibility Criteria
Criteria
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:
-
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;
-
Patients with unstable primary central nervous system (CNS) tumors or CNS metastases;
-
Patients who have an active autoimmune disease or have had an autoimmune disease with risk of recurrence;
-
Patients who have active or history of interstitial lung disease or non-infectious pneumonia;
-
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/exclusion criteria apply.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Shanghai Pulmonary Hospital | Shanghai | Shanghai | China | 200433 |
Sponsors and Collaborators
- Beijing InnoCare Pharma Tech Co., Ltd.
Investigators
- Principal Investigator: Caicun Zhou, Shanghai Pulmonary Hospital, Shanghai, China
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ICP-CL-00801