Trial Search Results

A Study of H3B-8800 in Participants With Myelodysplastic Syndromes, Acute Myeloid Leukemia, and Chronic Myelomonocytic Leukemia

The main purpose of this study is to determine the safety of the study drug H3B-8800 in humans and to understand better how the study drug works in your type of cancer. The study will also collect information on how long you live and the side effects that you may experience during the study.

Stanford is currently accepting patients for this trial.

Lead Sponsor:

H3 Biomedicine Inc.

Collaborator: Eisai Inc.

Stanford Investigator(s):

Intervention(s):

  • Drug: H3B-8800

Phase:

Phase 1

Eligibility


Inclusion Criteria:

   1. Confirmed diagnosis of MDS, CMML, or AML. For the MDS expansion cohort, participants
   must be lower-risk MDS, defined as low or intermediate-1 risk categorization per
   International Prognostic Scoring System (IPSS) criteria that carries a missense SF3B1
   mutation at a variant allele frequency of 5 percent (%) or higher.

   2. The participant must meet the following criteria relevant to their specific diagnosis:

   A. Participants with higher-risk MDS/CMML must be intolerant of hypomethylating agents
   (HMAs) or not have responded to 4 treatment cycles of decitabine or 6 treatment cycles
   of azacitidine, or must have progressed at any point after initiation of an HMA.

   B. For dose escalation portion, participants with lower-risk MDS/CMML must be
   transfusion-dependent for red blood cells or platelets (as determined by instructional
   practices or local standard of care). For enrollment MDS expansion cohort, lower risk
   MDS participants must be RBC transfusion dependent according to IWG 2006 criteria
   (having received at least 4 units (U) of RBCs within 8 weeks for hemoglobin (Hb) of
   less than (<) 9 gram per deciliter (g/dL) prior to first dose of H3B-8800).
   Participants who are RBC transfusion-dependent must also have failed erythropoiesis
   stimulating agents (ESA) (primary resistance or relapse after a response) or have
   serum erythropoietin (EPO) levels greater than (>) 500 units per liter (U/L).

   C. Participants with AML must either refuse or not be considered candidates for
   intensive induction chemotherapy using consensus criteria for defining such
   participants. Previously treated participants should have evidence of persistent or
   recurrent AML in the peripheral blood and/or bone marrow that is refractory to, or has
   relapsed from, their most recent prior line of treatment. For AML, participants must
   have white blood cells (WBC) < 15*10^9/liter (L).

   D. Participants with CMML must have been treated with at least one prior therapy
   (hydroxyurea or a hypomethylating agent [HMA]).

   3. Eastern Cooperative Oncology Group (ECOG) performance score of 0-2.

   4. For expansion cohort- absolute neutrophil count (ANC) greater than or equal to (>=)
   500/ microliter (mcL) (0.5*10^9/L).

   5. For expansion cohort- platelet count >50,000/mcL (50*10^9/L).

   6. Adequate baseline organ function.

Exclusion Criteria:

   1. Diagnosis of a core binding factor leukemia (t(8;21), t(16;16) or inv(16)).

   2. Participant is deemed candidate for hematopoietic stem cell transplants at the time of
   enrollment (for AML participants only).

   3. Family history of Leber Hereditary Optic Neuropathy, Autosomal Dominant Optic Atrophy,
   Late-Onset Retinal Degeneration, Familial Dysautonomia or other hereditary
   mitochondrial disease, unless the causative mutation(s) in the family have been
   determined and the participant has tested negative for the mutation(s).

   4. Known prior or current retinal or optic nerve disease (example, Retinitis Pigmentosa,
   diabetic retinopathy, optic neuritis) based on screening ophthalmology assessment for
   eligibility.

   5. Corrected vision is worse than 20/40 unless due to cataracts.

   6. Vitamin B12, folate or vitamin A deficiency. Rescreening following repletion therapy
   is acceptable.

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Anousheh Afjei
650-723-8594
Recruiting