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Recruiting Phase 1 NCT06414434

BTX-A51 in Patients With Liposarcoma or CIC-rearranged Sarcoma

Trial Parameters

Condition Liposarcoma
Sponsor Michael Wagner, MD
Study Type INTERVENTIONAL
Phase Phase 1
Enrollment 24
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2024-09-30
Completion 2026-06-01
Interventions
BTX-A51

Brief Summary

This study is testing two different doses of BTX-A51 to determine if it is safe and tolerable in participants with liposarcoma with MDM2 amplification, myxoid liposarcoma, and CIC-rearranged sarcoma. The name of the study drug used in this research study is: -BTX-A51 (a type of kinase inhibitor)

Eligibility Criteria

Inclusion Criteria: * Study participants must have histologically-confirmed metastatic and/or recurrent liposarcoma (limited to the subtypes of well-differentiated and/or dedifferentiated liposarcoma, which are associated with MDM2 amplifications), or myxoid liposarcoma, or CIC-rearranged sarcoma. * ECOG performance status ≤2 * Adequate organ and marrow function as defined by the following metrics resulted within 7 days of study enrollment: * WBC \>3000/mm3 * Platelets \>75,000μl * ANC \>1500μl * Hgb \>9g/dl * Creatinine \<1.5 x ULN or measured CrCl of \>60ml/m2/1.73 m2 * Total bilirubin \<2 x ULN * AST/ALT \<3 x ULN * Participants must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non- nodal lesions and short axis for nodal lesions) as ≥20 mm (≥2 cm) by chest x-ray or as ≥10 mm (≥1 cm) with CT scan, MRI, or calipers by clinical exam. See Section 11 (Measurement of Effect) for the e

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