A Phase 1/2 Study of CG001419 Tablets in Adult Subjects With Locally Advanced or Metastatic Solid Tumours Harbouring NTRK Gene Abnormalities
Recruiting now · Phase 1/Phase 2
Conditions studied: Solid Tumors Harboring NTRK Fusion, NTRK, NTRK Gene Fusion, NTRK Fusion Positive
In brief
The goal of this clinical trial is to learn about the safety of drug CG001419. It also learn if drug CG001419 works to treat in locally advanced/metastatic adult solid tumours with NTRK gene fusions, NTRK gene point mutations, and NTRK gene amplification or over expression. The main questions it aims to answer are: Phase1:To determind the Maximum Tolerated Dose (MTD) and/or Phase 2 Recommended Dose for Phase 2 (RP2D) of CG001419 administered orally to adult subjects with locally advanced/metastatic solid tumours. To establish the safety and tolerability profile of CG001419. Phase2:To evaluate the efficacy of CG001419 in adult subjects with locally advanced or metastatic solid tumours harbouring oncogenic NTRK fusions, mutations, amplifications or over expression. Participants will Receive treatment with CG001419 until disease progression.
Key facts
- Study ID
- NCT07394374
- Run by
- Cullgen (Shanghai),Inc
- People needed
- 42
- Starts
- 2023-06-20
- Expected to finish
- 2030-08-30
- Last updated by the study team
- 2026-02-06
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- The Cancer Hospital, Chinese Academy of Medical Sciences — Beijing, China (enrolling)
- West China Hospital of Sichuan University — Chengdu, China (enrolling)
- Sun Yat-sen Memorial Hospital, Sun Yat-sen University — Guangzhou, China (enrolling)
- The Sir Run Run Shaw Hospital, Affiliated to Zhejiang University School of Medicine — Hangzhou, China (enrolling)
- Zhejiang Provincial Cancer Hospital — Hangzhou, China (enrolling)
- Shanxi Provincial Cancer Hospital — Taiyuan, China (enrolling)
Full record on ClinicalTrials.gov
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