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

Inclusion Criteria18

• 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 evaluation of measurable disease.
• Patients must have recovered from toxicity related to prior therapy to grade \<=1 (defined by CTCAE v5.0) (except alopecia and neuropathy, or immunotherapy related hypothyroidism)
• As the effect of this study drug on the developing human fetus is not known, women of child-bearing potential and men must agree to use at least 2 methods of contraception (abstinence; hormonal or barrier method of birth control) for the study and at least 2 months after completion.
• Female patient of childbearing potential has a negative serum pregnancy test within 7 days of study enrollment.
• Ability to understand and the willingness to sign a written informed consent document.
• Age ≥18 years
• Patients must have completed all prior anti-cancer treatment for liposarcoma, including radiation, ≥ 14 days prior to registration.