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

NCT ID: NCT05745623

Last Updated: 2025-09-11

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-27
• Study Completion Date: 2028-12-25

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

Conditions

Advanced Solid Tumors Harboring NTRK Fusion; Primary Central Nervous System Tumors Harboring NTRK Fusion

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ICP-723

Group Type: EXPERIMENTAL

ICP-723

Intervention Type: DRUG

ICP-723 tablet administered orally，once a day，for every 28 days as one cycle

Interventions

ICP-723

ICP-723 tablet administered orally，once a day，for every 28 days as one cycle

Intervention Type: DRUG

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

• Minimum Eligible Age: 2 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing InnoCare Pharma Tech Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ruihua Xu

Role: PRINCIPAL_INVESTIGATOR

Sun Yat-sen University

Locations

Sun Yat-Sen University Cancer Center

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Ruihua Xu

Role: CONTACT

xurh@sysucc.org.cn

020-87343333

Yuhong Li

Role: CONTACT

liyh@sysucc.org.cn

Facility Contacts

RuiHua Xu

Role: primary

Other Identifiers

ICP-CL-00505

Identifier Type: -

Identifier Source: org_study_id