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NCT Number: NCT05745623

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

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Key information

Conditions

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

Age range

2 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Sun Yat-Sen University Cancer Center

Guangzhou, Guangdong, 510060, China

Location status: Recruiting

Location contact

RuiHua Xu

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

ICP-723

Drug

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

Primary outcomes

  1. Objective response rate (ORR)

    Time frame: Through study completion, an average of 4 years

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

Secondary outcomes

  1. ORR assessed by the investigator

    Time frame: Through study completion, an average of 4 years

  2. DCR as assessed by the investigator and the IRC

    Time frame: Through study completion, an average of 4 years

  3. Time to response (TTR) as assessed by the investigator and the IRC

    Time frame: Through study completion, an average of 4 years

  4. Duration of response (DOR) as assessed by the investigator and the IRC

    Time frame: Through study completion, an average of 4 years

  5. Progression-free survival (PFS) as assessed by the investigator and the IRC

    Time frame: Through study completion, an average of 4 years

  6. Intracranial objective response rate (IC-ORR) as assessed by the investigator and IRC

    Time frame: Through study completion, an average of 4 years

  7. central nervous system progression-free survival (CNS-PFS) as assessed by the investigator and IRC

    Time frame: Through study completion, an average of 4 years

  8. Overall survival (OS)

    Time frame: Through study completion, an average of 4 years

  9. The incidence, character and severity of adverse events as assessed per NCI-CTCAE v5.0 criteria

    Time frame: Through study completion, an average of 4 years

  10. The maximum plasma concentration observed (Cmax)

    Time frame: Through study completion, an average of 4 years

  11. Time of maximum observed plasma concentration (Tmax)

    Time frame: Through study completion, an average of 4 years

  12. Elimination half-life (t1/2)

    Time frame: Through study completion, an average of 4 years

  13. AUC0-∞

    Time frame: Through study completion, an average of 4 years

  14. AUC0-t

    Time frame: Through study completion, an average of 4 years

  15. Apparent clearance (CL/F)

    Time frame: Through study completion, an average of 4 years

  16. Apparent volume of distribution (Vz/F)

    Time frame: Through study completion, an average of 4 years

Other outcomes

  1. Colony-stimulating factor (CSF) concentrations

    Time frame: Through study completion, an average of 4 years

Study contacts

Contact information is provided by the study sponsor or research team.

Ruihua Xu

CONTACT

[email protected]

020-87343333

Yuhong Li

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Beijing InnoCare Pharma Tech Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2027
Study completion
2028
First posted
Feb 27, 2023
Registry last updated
Sep 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.