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Phase 1/2 Study of TEW-7197 Monotherapy in Patients with Low or Intermediate Myelodysplastic Syndromes (MDS)
The goal of this study is to evaluate the safety and efficacy of an investigational drug called TEW-7197 when it is given to people with Myelodysplastic Syndromes (MDS). TEW-7197 is also currently being tested in other clinical research studies for other malignancies. TEW-7197 is being studied as a new potential anticancer drug and as a potential treatment for myelodysplasia. It is thought that TEW-7197 exerts its anticancer effect by interfering with critical cellular signaling pathways and preventing the tumor cells from dividing and growing.
Primary Objective: The primary objectives of this phase 1/2 trial are to evaluate the safety and tolerability of TEW-7197 monotherapy in a dose -escalation phase by defining the maximum tolerable dose (MTD) and determining 2 doses to be used in the second, proof-of-concept phase of the study to determine the best hematologic improvement (HI) maintained for 8 weeks and evaluate the efficacy and safety of TEW-7197 monotherapy in subjects with Myelodysplastic Syndromes (MDS). Secondary Objective(s) The secondary objectives of the study are as follows: To characterize the PK profile of TEW-7197 in patients with MDS. To document the time to best HI. To document the duration of best HI. To assess the effect on transfusion dependency for red blood cells and platelets. To evaluate the frequency of bone marrow response (CR+PR) and cytogenetic response. To determine changes of TGF-B-associated signaling-related biomarkers (for example, pSMAD2 inhibition in bone marrow). To evaluate the relationship between mutations and response. To evaluate the relationship between various stem and progenitor alterations and response. To evaluate the quality of life parameters experienced by patients with MDS. To summarize vital signs, physical findings, adverse events, laboratory findings, and tumor imaging evaluation results.