Evaluating ICP-723 for advanced solid tumors and CNS tumors with NTRK fusions
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
This study is testing a new drug called ICP-723 to see if it can help people with advanced solid tumors or brain tumors that have specific gene changes.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 2 Years and up |
| Sex | All |
| Sponsor | Beijing InnoCare Pharma Tech Co., Ltd. Industry-sponsored |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT05745623 on ClinicalTrials.gov |
What this trial studies
This clinical trial is a multi-center, non-randomized, open-label study designed to evaluate the efficacy and safety of ICP-723 in patients with advanced solid tumors or primary central nervous system tumors that harbor NTRK gene fusions. Participants must have measurable lesions and have not previously received NTRK inhibitor treatment. The trial aims to gather data on the drug's performance in this specific patient population, utilizing established criteria for assessment.
Who should consider this trial
Good fit: Ideal candidates are patients with advanced solid tumors or primary CNS tumors that have NTRK gene fusions and an ECOG performance status of 0-1.
Not a fit: Patients with unstable CNS tumors or those who have previously received NTRK inhibitor treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced tumors that have limited treatment alternatives.
How similar studies have performed: Other studies targeting NTRK fusions have shown promising results, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Guangzhou, Guangdong
- Sun Yat-Sen University Cancer Center — Guangzhou, Guangdong, China (Recruiting)
Study contacts
- Principal investigator: Ruihua Xu — Sun Yat-Sen University Cancer Center
- Study coordinator: Ruihua Xu
- Email: xurh@sysucc.org.cn
- Phone: 020-87343333
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.