This trial is currently open and accepting patients.
The following criteria is a partial list of reasons why patients may be eligible to participate in this clinical trial. Further evaluation with a medical professional is required.
Enrollment: 112 patients (estimated)View More
November 15, 2022
Up to July 25, 2022, 17 patients have been treated with RVU120 at doses from 10 mg to 110 mg per day on day 1, 3, 5, 7, 9, 11 and 13 in a 21-day cycle. Three patients had HR-MDS and 14 had AML, relapsed/refractory to a median of 3 prior lines of therapy, median age was 71 years and ECOG PS was 0-1 in 10 patients and 2 in 7 patients. Most frequent all grade Adverse Events (AE) were nausea (in 55% of patients), thrombocytopenia (33%) and febrile neutropenia (33%), hypokalemia (27%) and vomiting (27%). Drug discontinuation due to AE occurred in 5 patients, Clinical benefit was observed in 11 evaluable patients. Best response was 1 CR and 10 disease stabilizations (SD), 2 of which associated with Hematological Improvement due to increased Erythroid differentiation and/or Platelet recovery, and 4 with BM blast reduction. At the dose level of 100 mg, one patient with AML, refractory to 4 prior lines of therapy and with GATA2 rearrangement, achieved SD and is ongoing at Cycle 4 with platelet recovery and RBC transfusion independence; 1 patient with HR-MDS, progressing after 5 lines of therapy, showed a SD with BM blasts clearance at flow cytometry in an unscheduled efficacy evaluation. The third patient dosed at 100 mg died due to SAE of pneumonia with no post treatment BM evaluation. 2 additional patients (1 treated at 75 mg and 1 at 85 mg) are still ongoing after nearly 6 months of treatment. Both achieved SD. All patients' CD34+ blasts were tested for relative STAT5 phosphorylation changes from baseline. Results showed a clear correlation between pSTAT5 inhibition and RVU120 exposure.
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