AB8939 for Acute Myeloid Leukemia

Recruiting at 9 trial locations

Overseen By Clinical Study Coordinator

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: AB Science

Disqualifiers: Standard care, HSCT eligible, CNS leukemia, others

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

Compensation: Varies

Number of Visits: Unknown

78 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests AB8939, a new drug, for safety and effectiveness in patients with certain blood cancers that haven't responded to other treatments. The study will determine the best dose and schedule for future trials.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Research Team

Norbert Vey, MD

Principal Investigator

Institut Paoli Calmettes, Marseille, France

Nicholas Short, MD

Principal Investigator

MD Anderson Cancer Center, Houston, Texas

Eligibility Criteria

This trial is for adults with Acute Myeloid Leukemia or high-risk Myelodysplastic Syndromes who've had previous treatments fail. They must be in good physical condition (ECOG ≤ 1), able to consent, and follow study procedures like bone marrow biopsies. It's not for those eligible for standard care, stem cell transplant, have certain leukemia types or CNS involvement, recent transplants, or are pregnant/breastfeeding.

Inclusion Criteria

I have acute myeloid leukemia and need second or third line treatment.

I am fully active and can carry on all my pre-disease activities without restriction.

I have a high-risk myelodysplastic syndrome not responding to first treatments.

Exclusion Criteria

I am eligible for a stem cell transplant.

I am currently pregnant.

I have active leukemia in my brain or spinal cord.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Dose escalation study to determine safety, tolerability, and pharmacokinetic profiles of AB8939

8 weeks

Multiple visits (in-person)

Dose Expansion

Dose expansion study to determine the schedule for Phase 2 and provide early efficacy assessment

8 weeks

Multiple visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• AB8939

Trial Overview The trial tests AB8939's safety and tolerability in patients with AML by finding the highest dose they can take without serious side effects. Participants will also receive Azacitidine as part of the treatment regimen.

Participant Groups

Group I: AB8939 plus azacitidine Experimental Treatment 2 Interventions

AB8939 administered in combination with azacitidine

Group II: AB8939 Experimental Treatment 1 Intervention

AB8939 administered as a single agent

Who Is Running the Clinical Trial?

AB Science

Lead Sponsor

Trials

39

Recruited

15,700+