Cruces (vizcaya), Spain

  • BTX-A51 in Patients With Liposarcoma

    This is a single arm, pilot study assessing the safety and preliminary exploration of BTX-A51 in participants with metastatic and/or recurrent liposarcomas characterized by Murine Double Minute Clone 2 (MDM2) amplifications. BTX-A51 works in a different way from currently approved therapies used to treat liposarcoma by blocking proteins called CK1α and CDK9. The U.S. Food and Drug Administration (FDA) has not approved BTX-A51 as a treatment for Liposarcoma. The research study procedures include screening for eligibility, Computerized Tomography (CT) scans, Magnetic Resonance Imaging (MRI) scans, or Positron Emission Tomography (PET) scans, blood tests, and tumor biopsies. Participants will receive study treatment for as long as there are no serious side effects, and disease does not get worse. Participants will be followed for 1 year after the last dose of BTX-A51. It is expected that about 12 people will take part in this research study. Edgewood Oncology is supporting this research study by providing the study drug.

    Phase

    1

    Span

    140 weeks

    Sponsor

    Michael Wagner, MD

    Recruiting

  • A Study of Mirdametinib in Combination With Palbociclib in People With Liposarcoma

    Phase

    1/2

    Span

    183 weeks

    Sponsor

    Memorial Sloan Kettering Cancer Center

    Recruiting

  • APG-115 in Combination With PD-1 Inhibitor in Patients With Advanced Liposarcoma or Advanced Solid Tumors

    Part 1 is the open label, dose-escalation phase Ib portion of the study to establish an MTD/RP2D of APG-115 in combination with toripalimab. Dose levels/schedule of APG115 will be tested: 50mg, 100mg, 150mg, and 200mg, QOD with 2 weeks on 1 week off as a cycle of 21 days (3 weeks), toripalimab will administrated with label dose. Part 2 is the phase II portion of the study to evaluate the clinical efficacy and safety of the RP2D of APG-115 in combination with label dose of toripalimab in patients with advanced liposarcoma. In this part, Simon's two-stage design (Simon R (1989). Controlled Clinical Trials 10: 1-10.) will be used. The null hypothesis that the true response rate of combination is 30% or lower will be tested against a one-sided alternative. In the first stage, 19 patients will be accrued. If there are 3 or fewer responses in these patients, the study will be stopped. Otherwise, 15 additional patients will be accrued for a total of 34. The null hypothesis will be rejected if 7 or more responses are observed in 34 patients. This design yields a type I error rate of 0.05 and power of 90%.

    Phase

    1/2

    Span

    297 weeks

    Sponsor

    Ascentage Pharma Group Inc.

    Recruiting

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