Clinical trial NCT05745623: Study of ICP-723 in Patients with Advanced Solid Tumors or Primary Central Nervous System Tumors
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Advanced Solid Tumors Harboring NTRK Fusion
Primary Central Nervous System Tumors Harboring NTRK Fusion
Lead sponsor: Beijing InnoCare Pharma Tech Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-02-27
Enrollment: 55
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Objective response rate (ORR)
timeFrame: Through study completion, an average of 4 years
Secondary outcomes:
measure: ORR assessed by the investigator
timeFrame: Through study completion, an average of 4 years
measure: DCR as assessed by the investigator and the IRC
timeFrame: Through study completion, an average of 4 years
measure: Time to response (TTR) as assessed by the investigator and the IRC
timeFrame: Through study completion, an average of 4 years
measure: Duration of response (DOR) as assessed by the investigator and the IRC
timeFrame: Through study completion, an average of 4 years
measure: Progression-free survival (PFS) as assessed by the investigator and the IRC
timeFrame: Through study completion, an average of 4 years
measure: Intracranial objective response rate (IC-ORR) as assessed by the investigator and IRC
timeFrame: Through study completion, an average of 4 years
measure: central nervous system progression-free survival (CNS-PFS) as assessed by the investigator and IRC
timeFrame: Through study completion, an average of 4 years
measure: Overall survival (OS)
timeFrame: Through study completion, an average of 4 years
measure: The incidence, character and severity of adverse events as assessed per NCI-CTCAE v5.0 criteria
timeFrame: Through study completion, an average of 4 years
measure: The maximum plasma concentration observed (Cmax)
timeFrame: Through study completion, an average of 4 years
measure: Time of maximum observed plasma concentration (Tmax)
timeFrame: Through study completion, an average of 4 years
measure: Elimination half-life (t1/2)
timeFrame: Through study completion, an average of 4 years
measure: AUC0-∞
timeFrame: Through study completion, an average of 4 years
measure: AUC0-t
timeFrame: Through study completion, an average of 4 years
measure: Apparent clearance (CL/F)
timeFrame: Through study completion, an average of 4 years
measure: Apparent volume of distribution (Vz/F)
timeFrame: Through study completion, an average of 4 years
Other outcomes:
measure: Colony-stimulating factor (CSF) concentrations
timeFrame: Through study completion, an average of 4 years
Locations:
city: Guangzhou
country: China
facility: Sun Yat-Sen University Cancer Center
state: Guangdong
Study officials:
affiliation: Sun Yat-sen University
name: Ruihua Xu
role: PRINCIPAL_INVESTIGATOR
References: