A Phase 2 Study of ICP-723 in Patients With Advanced Solid Tumors or Primary Central Nervous System Tumors

• Status: Recruiting
• Trial end date: 2026-12-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Beijing InnoCare Pharma Tech Co., Ltd.

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