To hear about similar clinical trials, please enter your email below
Trial Title:
A Phase 2 Study of ICP-723 in Patients With Advanced Solid Tumors or Primary Central Nervous System Tumors
NCT ID:
NCT05745623
Condition:
Advanced Solid Tumors Harboring NTRK Fusion
Primary Central Nervous System Tumors Harboring NTRK Fusion
Conditions: Official terms:
Neoplasms
Nervous System Neoplasms
Central Nervous System Neoplasms
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
ICP-723
Description:
ICP-723 tablet administered orally，once a day，for every 28 days as one cycle
Arm group label:
ICP-723
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
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;
2. 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;
3. 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.
4. Organ functions meet the clinical criteria
Exclusion Criteria:
1. Patients with unstable primary central nervous system (CNS) tumors or CNS
metastasis.
2. Patients with abnormal QTc interval at screening, or other clinically significant
abnormalities in electrocardiographic examination at the discretion of the
investigator.
3. Patient with recent anti-tumor and other treatment as stated in the protocol.
4. Grade 1 or higher toxicities attributed to any previous treatment not yet recovered.
5. Other conditions considered unsuitable for participation in this trial at the
discretion of the investigator
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Sun Yat-Sen University Cancer Center
Address:
City:
Guangzhou
Zip:
510060
Country:
China
Status:
Recruiting
Contact:
Last name:
RuiHua Xu
Start date:
December 27, 2022
Completion date:
December 2026
Lead sponsor:
Agency:
Beijing InnoCare Pharma Tech Co., Ltd.
Agency class:
Industry
Source:
Beijing InnoCare Pharma Tech Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05745623
