NCT05745623 Study of ICP-723 in Patients With Advanced Solid Tumors or Primary Central Nervous System Tumors
| NCT ID | NCT05745623 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Beijing InnoCare Pharma Tech Co., Ltd. |
| Condition | Advanced Solid Tumors Harboring NTRK Fusion |
| Study Type | INTERVENTIONAL |
| Enrollment | 70 participants |
| Start Date | 2022-12-27 |
| Primary Completion | 2027-12-25 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 70 participants in total. It began in 2022-12-27 with a primary completion date of 2027-12-25.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
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
Contact & Investigator
Ruihua Xu
PRINCIPAL INVESTIGATOR
Sun Yat-Sen University Cancer Center
Frequently Asked Questions
Who can join the NCT05745623 clinical trial?
This trial is open to participants of all sexes, aged 2 Years or older, studying Advanced Solid Tumors Harboring NTRK Fusion. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05745623 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05745623 currently recruiting?
Yes, NCT05745623 is actively recruiting participants. Contact the research team at xurh@sysucc.org.cn for enrollment information.
Where is the NCT05745623 trial being conducted?
This trial is being conducted at Guangzhou, China.
Who is sponsoring the NCT05745623 clinical trial?
NCT05745623 is sponsored by Beijing InnoCare Pharma Tech Co., Ltd.. The principal investigator is Ruihua Xu at Sun Yat-Sen University Cancer Center. The trial plans to enroll 70 participants.