45 Participants Needed

CG-806 for Acute Myeloid Leukemia and High-Risk MDS

Recruiting at 9 trial locations
RB
NK
Overseen ByNawazish Khan, MD, MS
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

This study is being done to evaluate the safety, tolerability and antitumor activity of oral CG-806 (luxeptinib) for the treatment of patients with Acute Myeloid Leukemia (except APML), secondary AML, therapy-related AML, or higher-risk MDS, whose disease has relapsed, is refractory or who are ineligible for or intolerant of intensive chemotherapy or transplantation.

Research Team

RB

Rafael Bejar, MD, PhD

Principal Investigator

Aptose Biosciences Inc.

Eligibility Criteria

This trial is for adults over 18 with relapsed or stubborn Acute Myeloid Leukemia (AML) or high-risk Myelodysplastic Syndrome (MDS), who can't have intense chemo or a transplant. They should be fairly active, able to swallow pills, and not on other experimental drugs recently.

Inclusion Criteria

My blood counts are within normal ranges, unless caused by my condition.
You are expected to live for at least 3 more months.
My kidney, liver, and heart are functioning well.
See 3 more

Exclusion Criteria

I haven't received any cell-based immune therapy in the last 4 weeks.
I haven't taken experimental drugs or had chemotherapy in the last 14 days.
I have GVHD and need drugs to suppress my immune system.
See 2 more

Treatment Details

Interventions

  • CG-806
Trial OverviewThe study tests CG-806 (luxeptinib), an oral medication, to see if it's safe and effective against certain types of AML/MDS that haven't responded well to other treatments or when patients can't handle stronger therapies.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Dose Escalation and ExpansionExperimental Treatment1 Intervention
Dose Escalation and Expansion; CG-806 will be given orally in ascending doses in patients with relapsed or refractory AML or higher-risk MDS (escalation cohort), until the maximum tolerated dose or candidate recommended Phase 2 dose is reached. Followed up by up to 50 patients enrolled in the expansion cohort at the recommended dose.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Aptose Biosciences Inc.

Lead Sponsor

Trials
8
Recruited
850+