Back to resultsA Phase 2 Study of ICP-723 in Patients With Advanced Solid Tumors or Primary Central Nervous System Tumors
Primary Purpose
Advanced Solid Tumors Harboring NTRK Fusion, Primary Central Nervous System Tumors Harboring NTRK Fusion
Status
Recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
ICP-723
Sponsored by
About this trial
This is an interventional treatment trial for Advanced Solid Tumors Harboring NTRK Fusion
Eligibility 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
Sites / Locations
- Sun Yat-Sen University Cancer CenterRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
ICP-723
Arm Description
Outcomes
Primary Outcome Measures
Objective response rate (ORR)
The objective response rate (ORR) evaluated by the Independent Center Review
Secondary Outcome Measures
ORR assessed by the investigator
DCR as assessed by the investigator and the IRC
Time to response (TTR) as assessed by the investigator and the IRC
Duration of response (DOR) as assessed by the investigator and the IRC
Progression-free survival (PFS) as assessed by the investigator and the IRC
Intracranial objective response rate (IC-ORR) as assessed by the investigator and IRC
central nervous system progression-free survival (CNS-PFS) as assessed by the investigator and IRC
Overall survival (OS)
The incidence, character and severity of adverse events as assessed per NCI-CTCAE v5.0 criteria
The maximum plasma concentration observed (Cmax)
Time of maximum observed plasma concentration (Tmax)
Elimination half-life (t1/2)
AUC0-∞
AUC0-t
Apparent clearance (CL/F)
Apparent volume of distribution (Vz/F)
Full Information
NCT ID
NCT05745623
First Posted
February 16, 2023
Last Updated
February 16, 2023
Sponsor
Beijing InnoCare Pharma Tech Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT05745623
Brief Title
A Phase 2 Study of ICP-723 in Patients With Advanced Solid Tumors or Primary Central Nervous System Tumors
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 27, 2022 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
December 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Beijing InnoCare Pharma Tech Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Solid Tumors Harboring NTRK Fusion, Primary Central Nervous System Tumors Harboring NTRK Fusion
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
55 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ICP-723
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
ICP-723
Intervention Description
ICP-723 tablet administered orally，once a day，for every 28 days as one cycle
Primary Outcome Measure Information:
Title
Objective response rate (ORR)
Description
The objective response rate (ORR) evaluated by the Independent Center Review
Time Frame
Through study completion, an average of 4 years
Secondary Outcome Measure Information:
Title
ORR assessed by the investigator
Time Frame
Through study completion, an average of 4 years
Title
DCR as assessed by the investigator and the IRC
Time Frame
Through study completion, an average of 4 years
Title
Time to response (TTR) as assessed by the investigator and the IRC
Time Frame
Through study completion, an average of 4 years
Title
Duration of response (DOR) as assessed by the investigator and the IRC
Time Frame
Through study completion, an average of 4 years
Title
Progression-free survival (PFS) as assessed by the investigator and the IRC
Time Frame
Through study completion, an average of 4 years
Title
Intracranial objective response rate (IC-ORR) as assessed by the investigator and IRC
Time Frame
Through study completion, an average of 4 years
Title
central nervous system progression-free survival (CNS-PFS) as assessed by the investigator and IRC
Time Frame
Through study completion, an average of 4 years
Title
Overall survival (OS)
Time Frame
Through study completion, an average of 4 years
Title
The incidence, character and severity of adverse events as assessed per NCI-CTCAE v5.0 criteria
Time Frame
Through study completion, an average of 4 years
Title
The maximum plasma concentration observed (Cmax)
Time Frame
Through study completion, an average of 4 years
Title
Time of maximum observed plasma concentration (Tmax)
Time Frame
Through study completion, an average of 4 years
Title
Elimination half-life (t1/2)
Time Frame
Through study completion, an average of 4 years
Title
AUC0-∞
Time Frame
Through study completion, an average of 4 years
Title
AUC0-t
Time Frame
Through study completion, an average of 4 years
Title
Apparent clearance (CL/F)
Time Frame
Through study completion, an average of 4 years
Title
Apparent volume of distribution (Vz/F)
Time Frame
Through study completion, an average of 4 years
Other Pre-specified Outcome Measures:
Title
Colony-stimulating factor (CSF) concentrations
Time Frame
Through study completion, an average of 4 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ruihua Xu
Phone
020-87343333
Email
xurh@sysucc.org.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Yuhong Li
Email
liyh@sysucc.org.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ruihua Xu
Organizational Affiliation
Sun Yat-sen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sun Yat-Sen University Cancer Center
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
RuiHua Xu
12. IPD Sharing Statement
Learn more about this trial
A Phase 2 Study of ICP-723 in Patients With Advanced Solid Tumors or Primary Central Nervous System Tumors
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