A Phase 1/2 Open-Label Multi-Center First-in-Human Study of the Safety Tolerability Pharmacokinetics and Anti-Tumor Activity of TPX-0005 in Patients with Advanced Solid Tumors Harboring ALK ROS1 or NTRK1-3 Rearrangements (TRIDENT-1)

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    Advanced Solid Tumors Harboring Alk, Ros1, Or Ntrk1-3 Rearrangements
  • Age: Between 18 - 100 Years
  • Gender: Male or Female
  • Other Inclusion Criteria:
    1) Histologically or cytologically confirmed diagnosis of locally advanced, or metastatic solid tumor (including primary CNS tumors) that harbors a ROS1, ALK or NTRK1-3 gene fusion. 2) Subjects must have a documented ROS1, ALK or NTRK1-3 gene fusion that has been identified by local testing AND that has been prospectively confirmed by a central diagnostic laboratory selected by the Sponsor to determine molecular eligibility PRIOR to enrollment.

You may not be eligible for this study if the following are true:

  • 1) Concurrent participation in another therapeutic clinical trial. 2) Symptomatic brain metastases or leptomeningeal involvement. 3) History of previous cancer, except for squamous cell or basal-cell carcinoma of the skin, or any in situ carcinoma that has been completely resected, requiring therapy within the previous 2 years. 4) Major surgery within 4 weeks of start of repotrectinib treatment. Radiation therapy (except palliative to relieve bone pain) within 2 weeks of study entry. Palliative radiation (=10 fractions) must have been completed at least 48 hours prior to study entry.


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