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Clinical Trial Recruitment | Patient Recruitment for Clinical Study of TargetRx's third-generation ALK inhibitor TGRX-326 for NSCLC

2021-03-15 Views:

A phase I dose-escalation and expansion clinical trial to evaluate the safety, tolerability, pharmacokinetics and preliminary effectiveness of TGRX-326 in patients with ALK-positive or ROS1-positive advanced non-small cell lung cancer, sponsored by Shenzhen TargetRx Inc., is being carried out at Sun Yat-sen University Cancer Center. This study, which has obtained a clinical trial notification issued by the National Medical Products Administration (acceptance number: CXHL2000531, CXHL2000532) and was approved by the Ethics Committee of Sun Yat-sen University Cancer Center, is now recruiting patients with ALK-positive or ROS1-positive advanced non-small cell lung cancer from the society.

Introduction to the investigational product

TGRX-326 is a potent and highly selective third-generation ALK (anaplastic lymphoma kinase) / ROS1 (c-ros oncogene 1) inhibitor targeting the EML4-ALK fusion gene, which was independently developed by TargetRx, and is used to treat non-small cell lung cancer with ALK/ROS1 gene mutations.

Inclusion criteria

Inclusion criteria for recruiting subjects include:

  1. Male/female subjects aged ≥ 18 years;

  2. Patients with advanced NSCLC that is confirmed to be ALK positive or ROS1 positive by pathological examination;

  3. At least one measurable target lesion;

  4. For dose escalation and dose expansion phase: ECOG score 0-1 points; for indication expansion phase: score 0-2 points;

  5. Sufficient heart, liver, kidney, bone marrow, and blood coagulation functions;

  6. Expected survival period ≥3 months.

Consultation method

If you (or your family members, friends) meet the above criteria and are interested in participating or learning more about the research project, please consult Mr. Zeng (Tel: +86-20-87343459)