A Study of SY-3505 in Patients With Advanced LTK Fusion-Positive Solid Tumors
Trial Parameters
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Brief Summary
This is an open-label, single-arm, multicenter, phase Ib study to evaluate the efficacy and safety of SY-3505 capsule in patients with locally advanced or metastatic, LTK fusion-positive solid tumor who have progressed on or are intolerant to prior standard therapy.
Eligibility Criteria
Inclusion Criteria: * Patients must meet all of the following criteria to be eligible for this study: 1. Age ≥ 18 years at the time of signing the Informed Consent Form (ICF). 2. Histologically or cytologically confirmed locally advanced (as assessed by the investigator, unresectable tumor or tumor recurrence following standard therapy with evidence of progression \[PD\] or intolerance to prior therapy) or metastatic solid tumor and failure of standard treatment with evidence of disease progression on imaging. 3. Agreement to provide a required tumor tissue sample (preferably fresh biopsy tissue or archived tumor tissue within 2 years prior to first dosing) that has been tested by the central laboratory and determined to be positive for LTK gene fusion. 4. At least one measurable extracranial lesion as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v 1.1 criteria. 5. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1. 6. Expected survival of ≥ 3