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Study identifier: NCT07394374 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

A Phase 1/2 Study of CG001419 Tablets in Adult Subjects With Locally Advanced or Metastatic Solid Tumours Harbouring NTRK Gene Abnormalities

Condition: Solid Tumors Harboring NTRK Fusion · NTRK · NTRK Gene Fusion  ·  Sponsor: Cullgen (Shanghai),Inc

PhasePhase 1/Phase 2
Planned participants42
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Xiangyu Jin, MS  ·  +86 13858065096  ·  xiangyu.jin@cullgen.com

Qiao Yi  ·  qiao.yi@cullgen.com

Always discuss trial participation with your own doctor first.

Locations (6)

The Cancer Hospital, Chinese Academy of Medical SciencesBeijing, ChinaRecruiting
West China Hospital of Sichuan UniversityChengdu, ChinaRecruiting
Sun Yat-sen Memorial Hospital, Sun Yat-sen UniversityGuangzhou, ChinaRecruiting
The Sir Run Run Shaw Hospital, Affiliated to Zhejiang University School of MedicineHangzhou, ChinaRecruiting
Zhejiang Provincial Cancer HospitalHangzhou, ChinaRecruiting
Shanxi Provincial Cancer HospitalTaiyuan, ChinaRecruiting

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Source record: clinicaltrials.gov/study/NCT07394374