LP-108 + Azacitidine for Leukemia

Recruiting at 8 trial locations

Overseen By Anna Chen, MD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Newave Pharmaceutical Inc

Must not be taking: CYP3A4 inhibitors, CYP3A4 inducers, Statins, others

Disqualifiers: Promyelocytic leukemia, Recent HSCT, CNS involvement, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

36 Participants Needed

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

My blood cancer cell count is low enough to start the trial treatment.

My blood clotting, kidney, and liver functions are all within normal ranges.

I have a severe type of anemia called RAEB or my MDS is high-risk and not responding to treatment.

Exclusion Criteria

I haven't had a fever over 38.5°C without a known cause during the screening or on the first day of the study drug.

I don't have active brain involvement from my cancer, or if I did, it's now under control.

I do not have active or uncontrolled HIV, hepatitis B, or C.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Participants receive sequentially higher oral doses of LP-108 on a once daily schedule for 28 days per cycle

4 weeks per cycle, up to 13 cycles

Dose Expansion

Participants receive LP-108 in combination with azacitidine on a once daily schedule for 28 days per cycle

4 weeks per cycle, up to 13 cycles

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• LP-108
• LP-108 and Azacitidine

Trial Overview The study tests LP-108 alone and combined with azacitidine in pill form to see how safe it is and how well it works against specific blood cancers. The doses will be increased slowly to find the highest dose patients can take without bad side effects.

Participant Groups

Group I: Dose Expansion Phase: LP-108 in combination with azacitidine Experimental Treatment 1 Intervention

Three to 6 subjects per treatment cohort will be assigned to receive sequentially higher oral doses of LP-108 on a once daily schedule for 28 days (a "Cycle") starting at a dose of 100 mg in combination with azacitidine at 75 mg/m2.

Group II: Dose Escalation Phase: LP-108 monotherapy Experimental Treatment 1 Intervention

Three to 6 subjects per treatment cohort will be assigned to receive sequentially higher oral doses of LP-108 on a once daily schedule for 28 days (a "Cycle") starting at a dose of 100 mg.

Who Is Running the Clinical Trial?

Newave Pharmaceutical Inc

Lead Sponsor

Trials

4

Recruited

270+