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

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

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

Study Overview

• Status: Recruiting
• Conditions: Advanced Solid Tumors Harboring NTRK Fusion; Primary Central Nervous System Tumors Harboring NTRK Fusion
• Intervention / Treatment: Drug: ICP-723

• Study Type: Interventional
• Enrollment (Estimated): 70
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Ruihua Xu; Phone Number: 020-87343333; Email: xurh@sysucc.org.cn
• Study Contact Backup: Name: Yuhong Li; Email: liyh@sysucc.org.cn

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510060
      • Recruiting
      • Sun yat-sen University Cancer Center
      • Contact: Ruihua Xu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ICP-723	Drug: ICP-723; ICP-723 tablet administered orally，once a day，for every 28 days as one cycle

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective response rate (ORR)	The objective response rate (ORR) evaluated by the Independent Center Review	Through study completion, an average of 4 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Apparent clearance (CL/F)	Through study completion, an average of 4 years
ORR assessed by the investigator	Through study completion, an average of 4 years
DCR as assessed by the investigator and the IRC	Through study completion, an average of 4 years
Time to response (TTR) as assessed by the investigator and the IRC	Through study completion, an average of 4 years
Duration of response (DOR) as assessed by the investigator and the IRC	Through study completion, an average of 4 years
Progression-free survival (PFS) as assessed by the investigator and the IRC	Through study completion, an average of 4 years
Intracranial objective response rate (IC-ORR) as assessed by the investigator and IRC	Through study completion, an average of 4 years
central nervous system progression-free survival (CNS-PFS) as assessed by the investigator and IRC	Through study completion, an average of 4 years
Overall survival (OS)	Through study completion, an average of 4 years
The incidence, character and severity of adverse events as assessed per NCI-CTCAE v5.0 criteria	Through study completion, an average of 4 years
The maximum plasma concentration observed (Cmax)	Through study completion, an average of 4 years
Time of maximum observed plasma concentration (Tmax)	Through study completion, an average of 4 years
Elimination half-life (t1/2)	Through study completion, an average of 4 years
AUC0-∞	Through study completion, an average of 4 years
AUC0-t	Through study completion, an average of 4 years
Apparent volume of distribution (Vz/F)	Through study completion, an average of 4 years

Other Outcome Measures

Outcome Measure	Time Frame
Colony-stimulating factor (CSF) concentrations	Through study completion, an average of 4 years

Collaborators and Investigators

• Sponsor: Beijing InnoCare Pharma Tech Co., Ltd.
• Investigators: Principal Investigator: Ruihua Xu, Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start (Actual): December 27, 2022
• Primary Completion (Estimated): December 25, 2027
• Study Completion (Estimated): December 25, 2028

Study Registration Dates

• First Submitted: February 16, 2023
• First Submitted That Met QC Criteria: February 16, 2023
• First Posted (Actual): February 27, 2023

Study Record Updates

• Last Update Posted (Estimated): September 11, 2025
• Last Update Submitted That Met QC Criteria: September 10, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neoplasms by Site; Neoplasms; Nervous System Neoplasms; Central Nervous System Neoplasms
• Other Study ID Numbers: ICP-CL-00505

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No