A Phase 2 Study of ICP-723 in Patients With Advanced Solid Tumors or Primary Central Nervous System Tumors
Study Details
Study Description
Brief Summary
A Multi-center, Non-Randomized, Open-Label Phase 2 Basket Clinical Trial to Evaluate ICP-723 in Patients with Advanced Solid Tumors or Primary Central Nervous System Tumors
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1/Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: ICP-723
|
Drug: ICP-723
ICP-723 tablet administered orally，once a day，for every 28 days as one cycle
|
Outcome Measures
Primary Outcome Measures
- Objective response rate (ORR) [Through study completion, an average of 4 years]
The objective response rate (ORR) evaluated by the Independent Center Review
Secondary Outcome Measures
- ORR assessed by the investigator [Through study completion, an average of 4 years]
- DCR as assessed by the investigator and the IRC [Through study completion, an average of 4 years]
- Time to response (TTR) as assessed by the investigator and the IRC [Through study completion, an average of 4 years]
- Duration of response (DOR) as assessed by the investigator and the IRC [Through study completion, an average of 4 years]
- Progression-free survival (PFS) as assessed by the investigator and the IRC [Through study completion, an average of 4 years]
- Intracranial objective response rate (IC-ORR) as assessed by the investigator and IRC [Through study completion, an average of 4 years]
- central nervous system progression-free survival (CNS-PFS) as assessed by the investigator and IRC [Through study completion, an average of 4 years]
- Overall survival (OS) [Through study completion, an average of 4 years]
- The incidence, character and severity of adverse events as assessed per NCI-CTCAE v5.0 criteria [Through study completion, an average of 4 years]
- The maximum plasma concentration observed (Cmax) [Through study completion, an average of 4 years]
- Time of maximum observed plasma concentration (Tmax) [Through study completion, an average of 4 years]
- Elimination half-life (t1/2) [Through study completion, an average of 4 years]
- AUC0-∞ [Through study completion, an average of 4 years]
- AUC0-t [Through study completion, an average of 4 years]
- Apparent clearance (CL/F) [Through study completion, an average of 4 years]
- Apparent volume of distribution (Vz/F) [Through study completion, an average of 4 years]
Other Outcome Measures
- Colony-stimulating factor (CSF) concentrations [Through study completion, an average of 4 years]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;
-
Patients with advanced solid tumors or primary central nervous system (CNS) tumors harboring NTRK gene fusions as detected by the designated central laboratory, who received no previous NTRK inhibitor treatment;
-
At least one measurable lesion as per RECIST1.1 criteria, or for primary CNS tumors, at least one measurable lesion as per RANO or INRC criteria.
-
Organ functions meet the clinical criteria
Exclusion Criteria:
-
Patients with unstable primary central nervous system (CNS) tumors or CNS metastasis.
-
Patients with abnormal QTc interval at screening, or other clinically significant abnormalities in electrocardiographic examination at the discretion of the investigator.
-
Patient with recent anti-tumor and other treatment as stated in the protocol.
-
Grade 1 or higher toxicities attributed to any previous treatment not yet recovered.
-
Other conditions considered unsuitable for participation in this trial at the discretion of the investigator
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Sun Yat-Sen University Cancer Center | Guangzhou | Guangdong | China | 510060 |
Sponsors and Collaborators
- Beijing InnoCare Pharma Tech Co., Ltd.
Investigators
- Principal Investigator: Ruihua Xu, Sun Yat-sen University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ICP-CL-00505