LP-108 + Azacitidine for Leukemia
Trial Summary
What is the purpose of this trial?
A Phase 1, Multicenter, Open-label, Dose-escalation Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Clinical Activity of Orally Administered LP-108 as Monotherapy and in Combination with Azacitidine in Subjects with Relapsed or Refractory Myelodysplastic Syndromes (MDS), Chronic Myelomonocytic Leukemia (CMML), or Acute Myeloid Leukemia (AML)
Eligibility Criteria
This trial is for adults with certain advanced blood cancers like MDS, CMML, or AML that have come back or didn't respond to treatment. They should have functioning kidneys and liver, no serious heart issues, and a blast count under control. It's not for those who've had recent cancer treatments they haven't recovered from, stem cell transplants within the last 60 days, active brain involvement by leukemia, or are on strong drugs affecting liver enzymes.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Dose Escalation
Participants receive sequentially higher oral doses of LP-108 on a once daily schedule for 28 days per cycle
Dose Expansion
Participants receive LP-108 in combination with azacitidine on a once daily schedule for 28 days per cycle
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- LP-108
- LP-108 and Azacitidine
Find a Clinic Near You
Who Is Running the Clinical Trial?
Newave Pharmaceutical Inc
Lead Sponsor