Phase 1 Trial to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of Splicing Modulator H3B-8800 for Subjects With Myelodysplastic Syndromes, Acute Myeloid Leukemia, and Chronic Myelomonocytic Leukemia
Complete title: An Open-label, Multicenter Phase 1 Trial to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of Splicing Modulator H3B-8800 for Subjects With Myelodysplastic Syndromes, Acute Myeloid Leukemia, and Chronic Myelomonocytic Leukemia
This study will include a Phase 1 dose-finding portion (Cohorts A and B) and a four-arm expansion portion. The primary objectives of the study are to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of H3B-8800 administered orally in participants with Myelodysplastic Syndromes (MDS), Acute Myeloid Leukemia (AML), or Chronic Myelomonocytic Leukemia (CMML) and to assess the safety and tolerability of H3B-8800 as a single agent administered orally once daily on a 5 days on/9 days off repeated dosing schedule in 28-day cycles in participants with MDS, AML, or CMML.
** For Eligibility information, please click on the "Look up trial at NIH" link above. **
Other eligibility criteria may apply.
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Leukemia, Acute Myeloid (AML); Hematologic Malignancies; Leukemia; Myelodysplastic Syndromes (MDS); Leukemia, Myeloid; Myelodysplastic-Myeloproliferative Diseases; Leukemia, Chronic Myelomonocytic (CMML); Leukemia, Acute Myelomonocytic (AML-M4); Bone Marrow Diseases
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