Evaluating ICP-723 for advanced solid tumors and CNS tumors with NTRK fusions

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial is a multi-center, non-randomized, open-label study designed to evaluate the efficacy and safety of ICP-723 in patients with advanced solid tumors or primary central nervous system tumors that harbor NTRK gene fusions. Participants must have measurable lesions and have not previously received NTRK inhibitor treatment. The trial aims to gather data on the drug's performance in this specific patient population, utilizing established criteria for assessment.

Why it matters

Who can join: the full rules

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

Where it's running

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

Study contacts

• Principal investigator: Ruihua Xu — Sun Yat-Sen University Cancer Center
• Study coordinator: Ruihua Xu
• Email: xurh@sysucc.org.cn
• Phone: 020-87343333

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• CG001419 tablets for adults with advanced solid tumors that have NTRK gene changes.

  This will test whether the oral drug CG001419 is safe and can control advanced or metastatic solid tumors in adults whose cancers have NTRK fusions, mutations, or amplifications.

  Recruiting at 6 sites Phase 1/2 Cullgen (Shanghai),Inc · Beijing and 5 other locations · NCT07394374

• Using larotrectinib for advanced or recurrent solid tumors with NTRK gene fusion

  This study is testing how well larotrectinib works for adults and children with advanced or recurrent solid tumors caused by NTRK gene fusions.

  Recruiting Bayer · Multiple Locations · NCT04945330

• Investigating ANS03 for advanced solid tumors with specific genetic alterations

  This study is testing a new treatment called ANS03 to see if it can help people with advanced solid tumors that have specific genetic changes.

  Recruiting at 5 sites Phase 1 Avistone Biotechnology Co., Ltd. · New York, New York and 4 other locations · NCT06716138

• Repotrectinib safety in children with NTRK fusion cancers in Japan

  This study tests the safety of repotrectinib in children and teens with NTRK fusion–positive solid tumors in Japan during routine care.

  Recruiting at 2 sites Bristol-Myers Squibb · Minato-ku, Tokyo and 1 other locations · NCT07755826

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.