Actively Recruiting
Study to Evaluate ICP-723 in Patients With Advanced Solid Tumors or Primary Central Nervous System Tumors Harboring NTRK Fusion
Led by Beijing InnoCare Pharma Tech Co., Ltd. · Updated on 2025-09-11
70
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating ICP-723 in patients with advanced solid tumors or primary central nervous system (CNS) tumors that have NTRK gene fusions. This open-label, multi-center Phase 2 basket clinical trial aims to assess ICP-723's effects in people who have not previously received NTRK inhibitor treatment. The study focuses on patients with measurable tumors and good performance status to better understand treatment responses and safety. Participants receive ICP-723 tablets orally once a day, with each treatment cycle lasting 28 days. This is a non-randomized study without a placebo group, and all participants are given the study drug. The trial spans an average of four years during which researchers monitor tumor responses and other health outcomes. Throughout the study, participants undergo regular evaluations including tumor measurements using RECIST, RANO, or INRC criteria, depending on tumor type. Safety is closely monitored by assessing adverse events and heart function. Researchers also measure drug levels in the blood and track survival and disease progression. The total study duration allows for long-term follow-up of effectiveness and side effects.
CONDITIONS
Brief Title
Study of ICP-723 in Patients With Advanced Solid Tumors or Primary Central Nervous System Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
- Patients with advanced solid tumors or primary central nervous system tumors harboring NTRK gene fusions confirmed by central lab
- No prior treatment with NTRK inhibitors
- At least one measurable lesion per RECIST1.1 for solid tumors or RANO/INRC for CNS tumors
- Organ functions meet clinical criteria
You will not qualify if you...
- Unstable primary central nervous system tumors or CNS metastasis
- Abnormal QTc interval or significant ECG abnormalities at screening
- Recent anti-tumor or other specified treatments as per protocol
- Grade 1 or higher toxicities from previous treatments not recovered
- Any other condition deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated 28-day cycles until disease progression or discontinuation
Participants take ICP-723 tablets orally once a day in repeated 28-day cycles as part of the treatment for their tumors.
Visits occur regularly during treatment cycles as per study schedule
Trial Site Locations
Total: 1 location
1
Sun Yat-Sen University Cancer Center
Guangzhou, Guangdong, China, 510060
Actively Recruiting
Research Team
R
Ruihua Xu
Y
Yuhong Li
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Frequently Asked Questions
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