Study of Monzosertib In Patients With R/R AML Or High-Risk Myelodysplastic Syndrome
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorM.D. Anderson Cancer Center
About this trial
The goal of this clinical research study is to find the recommended dose of monzosertib in patients with relapsed/refractory AML and high-risk MDS. The safety and effects of monzosertib will also be studied.
Eligibility criteria
Qualifiers
Patients need to be adults ≥18 years with R/R AML, 'MDS/AML', MDS, or CMML, per the ICC 2022 or the WHO 2022 with ≥5% blasts at screening. 6,7
Relapsed or refractory disease is defined as: patient having received and have progressed or relapsed or intolerant to standard regimens, e.g., as listed in NCCN guidelines, or declined treatment with such therapies.
"Treated secondary AML" i.e., patients with antecedent hematological disorder, e.g., MDS, CMML, MPD/MPN, who progress to AML despite receiving treatment adequate for AML (per NCCN) for the antecedent hematological disorder, will be eligible due to recognized poor outcomes similar to R/R AML.
Patients with actionable mutations with available FDA-approved therapies, e.g., FLT3, IDH1/2, menin inhibitors may be enrolled after they have exhausted or ineligible for appropriate lines of FDA approved treatment options.
Disqualifiers
Patient has a white blood cell count > 15 x 10⁹/L. Hydroxyurea, and/or cytarabine use as supportive care is permitted to meet this criterion.10
Prior use of any cytotoxic chemotherapy, targeted therapy, immunotherapy, or investigational therapies within 2 weeks or 5 half-lives (whichever is shorter), prior to first dose of study treatment. Patients should have recovered from all prior therapy related toxicities. Patients may receive hydroxyurea or cytarabine for control of WBC count during this washout period.
Patient has uncontrolled systemic fungal, bacterial, viral or other infection with ongoing signs/symptoms despite appropriate treatment.
Decompensated congestive heart failure, clinically significant, uncontrolled arrhythmia prolonged QT interval corrected for heart rate (QTcF) to greater than 450 msec, or long QT syndrome, or history of Torsades de pointes. Patients with bundle branch block or pacemaker and prolonged QTc interval are permitted after appropriate correction, (e.g., Bogossian formula, or others) or after discussion with the PI and/or cardiologist. Acute respiratory failure, unstable or decompensated pulmonary disease
Trial design
Treatments tested in this trial
- Monzosertib
- Posaconazole
- Isavuconazole
Treatment groups
42 Participants
are divided into 3 treatment groupsSponsors and collaborators
M.D. Anderson Cancer Center
Lead sponsor
Carna Biosciences, Inc.
Collaborator
Source ClinicalTrials.gov