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

Recruiting at 9 trial locations

Overseen By Nawazish Khan, MD, MS

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Aptose Biosciences Inc.

Must not be taking: Immunosuppressive, Cytotoxic, Investigational drugs

Disqualifiers: GVHD, Leukostasis, Metabolic disorder, others

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

Compensation: Varies

Number of Visits: Unknown

45 Participants Needed

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

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.

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

CG-806 is given orally in ascending doses to determine the maximum tolerated dose or recommended Phase 2 dose

28 days per cycle

Multiple visits per cycle for dose escalation and monitoring

Cohort Expansion

Up to 50 patients are enrolled at the recommended dose to further evaluate safety and efficacy

28 days per cycle

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• CG-806

Trial Overview The 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

Group I: Dose Escalation and Expansion Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

Aptose Biosciences Inc.

Lead Sponsor

Trials

8

Recruited

850+