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Recruiting NCT05745623

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

Phase I / Phase II Interventional Advanced Solid Tumors Harboring NTRK Fusion Primary Central Nervous System Tumors Harboring NTRK Fusion

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: ICP-723.
Who it may be relevant to
Registry conditions: Advanced Solid Tumors Harboring NTRK Fusion, Primary Central Nervous System Tumors Harboring NTRK Fusion. Basic parameters: from 2 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official 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

Overview

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

Interventions

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

Primary outcome measures

  • Objective response rate (ORR) [Time frame: Through study completion, an average of 4 years]
Secondary outcome measures (12)
  • ORR assessed by the investigator [Time frame: Through study completion, an average of 4 years]
  • DCR as assessed by the investigator and the IRC [Time frame: Through study completion, an average of 4 years]
  • Time to response (TTR) as assessed by the investigator and the IRC [Time frame: Through study completion, an average of 4 years]
  • Duration of response (DOR) as assessed by the investigator and the IRC [Time frame: Through study completion, an average of 4 years]
  • Progression-free survival (PFS) as assessed by the investigator and the IRC [Time frame: Through study completion, an average of 4 years]
  • Intracranial objective response rate (IC-ORR) as assessed by the investigator and IRC [Time frame: Through study completion, an average of 4 years]
  • 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]
  • Overall survival (OS) [Time frame: Through study completion, an average of 4 years]
  • 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]
  • The maximum plasma concentration observed (Cmax) [Time frame: Through study completion, an average of 4 years]
  • Time of maximum observed plasma concentration (Tmax) [Time frame: Through study completion, an average of 4 years]
  • Elimination half-life (t1/2) [Time frame: Through study completion, an average of 4 years]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Sun Yat-Sen University Cancer Center — Guangzhou

Identifiers

NCT: NCT05745623 · ICP-CL-00505

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗