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

NCT05745623 | Recruiting Phase 1

• 1 other identifier: ICP-CL-00505
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Objective response rate (ORR)

  The objective response rate (ORR) evaluated by the Independent Center Review

  Through study completion, an average of 4 years

Secondary Outcomes (16)

• 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

Other Outcomes (1)

• Colony-stimulating factor (CSF) concentrations

  Through study completion, an average of 4 years

Study Arms (1)

ICP-723

EXPERIMENTAL

Drug: ICP-723

Interventions

ICP-723 DRUG

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

ICP-723

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;
• 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;
• 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.
• Organ functions meet the clinical criteria

You may not qualify if:

• Patients with unstable primary central nervous system (CNS) tumors or CNS metastasis.
• Patients with abnormal QTc interval at screening, or other clinically significant abnormalities in electrocardiographic examination at the discretion of the investigator.
• Patient with recent anti-tumor and other treatment as stated in the protocol.
• Grade 1 or higher toxicities attributed to any previous treatment not yet recovered.
• Other conditions considered unsuitable for participation in this trial at the discretion of the investigator

Sponsors & Collaborators

• Beijing InnoCare Pharma Tech Co., Ltd.: lead

Study Sites (1)

Sun Yat-Sen University Cancer Center

Guangzhou, Guangdong, 510060, China

RECRUITING

Study Officials

• Ruihua Xu

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ruihua Xu

CONTACT

020-87343333; xurh@sysucc.org.cn

Yuhong Li

CONTACT

liyh@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2023
• First Posted: February 27, 2023
• Study Start: December 27, 2022
• Primary Completion (Estimated): December 25, 2027
• Study Completion (Estimated): December 25, 2028
• Last Updated: September 11, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)