A Phase 2 Study of ICP-723 in Patients With Advanced Solid Tumors or Primary Central Nervous System Tumors

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05745623
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 1/Phase 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Beijing InnoCare Pharma Tech Co., Ltd.
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Ruihua Xu
Principal Investigator Affiliation	Sun Yat-sen University
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	China
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Advanced Solid Tumors Harboring NTRK Fusion, Primary Central Nervous System Tumors Harboring NTRK Fusion

Arms & Interventions

Arms

Experimental: ICP-723

Interventions

Drug: - ICP-723

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

Contact a Trial Team

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International Sites

Sun Yat-Sen University Cancer Center, Guangzhou, Guangdong, China

Status

Recruiting

Address

Sun Yat-Sen University Cancer Center

Guangzhou, Guangdong, 510060

Site Contact

RuiHua Xu

xurh@sysucc.org.cn

020-87343333

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