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

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age2+
SponsorBeijing InnoCare Pharma Tech Co., Ltd.

About this trial

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

Eligibility criteria

Qualifiers

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

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • ICP-723

Treatment groups

70 Participants
are divided into 1 treatment group