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

InnoCare Pharma

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Advanced Solid Tumors Harboring NTRK Fusion; Primary Central Nervous System Tumors Harboring NTRK Fusion

Treatments: Drug: ICP-723

Study type: Interventional

Funder types: Industry

Identifiers

NCT05745623

ICP-CL-00505

Details and patient eligibility

About

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

Enrollment: 70 estimated patients

Sex: All

Ages: 2+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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70 participants in 1 patient group

ICP-723

Experimental group

Treatment:

Drug: ICP-723