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)

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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 years - 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.

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.