RightFit
RecruitingPhase 1 / Phase 2

AB8939 in Patients With Relapsed/Refractory Acute Myeloid Leukemia

A Phase 1/2 Study to Assess the Safety, Pharmacokinetics, and Efficacy of Daily Intravenous AB8939 in Patients With Relapsed/Refractory Acute Myeloid Leukemia

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests the safety of AB8939 and finds the highest dose patients can tolerate and a dose for further testing. It is for people with acute myeloid leukemia (AML), a blood cancer, that has come back or has not responded to treatment. The dose-finding part also includes some people with high-risk myelodysplastic syndrome (MDS), a disease of the bone marrow.

The primary objective is to define the safety and tolerability of AB8939 in patients with AML by determining the dose-limiting toxicities, the maximum tolerated dose, and the recommended dose for dose expansion study.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have confirmed AML and be eligible for a second or third course of treatment.
  • For the dose-finding part, people with high-risk MDS that has not responded to treatment may also join if eligible for a second or third course of treatment.
  • For the dose-finding part, be fully active or able to do light work despite limits on hard physical activity.
  • For the later expansion part, be able to care for yourself and be up and about for more than half of waking hours, even if unable to work.
  • Be able to understand, sign, and date the consent form before any study procedures.
  • Be able and willing to follow study steps, including tests that take samples of bone marrow.
  • Other study rules may apply.

Who can't join

  • Are eligible for standard treatment.
  • Are eligible for a stem cell transplant when joining the study.
  • Have acute promyelocytic leukemia (M3), a type of AML.
  • Have active leukemia in the brain or spinal cord.
  • Had a stem cell transplant within 100 days before the first AB8939 dose.
  • Are breastfeeding or plan to breastfeed during the study.
  • Have a positive pregnancy test.
  • Other study rules may apply.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

DOSE ESCALATION STUDY Key Inclusion Criteria: * Patients with documented diagnosis of acute myeloid leukemia (AML) based on the last version of the World Health Organization classification and eligible to second or third line of treatment. * Patients with documented diagnosis of refractory melyodisplastic syndrome in second or third line of treatment, and with high risk at prognosis based on the IPSS-R scoring system. * ECOG performance status ≤ 1 * Patients are able to understand, sign, and date the written informed consent form at screening visit prior to any protocol-specific procedures * Patients are able and willing to comply with study procedures as per protocol, including bone marrow biopsies Key Exclusion Criteria: * Patients eligible to a standard of care * Patients eligible to hematopoietic stem cell transplantation (HSCT) at the time of inclusion * Patients diagnosed with acute promyelocytic leukemia (M3) * Patients with clinically active CNS leukemia * Patients with HSCT within 100 days prior to the first administration of AB8939 * Women who are lactating/breastfeeding or who plan to breastfeed while on study * Women with a positive pregnancy test Other protocol-defined inclusion/exclusion criteria may apply EXPANSION COHORT STUDY Key Inclusion Criteria: * Patients with documented diagnosis of acute myeloid leukemia (AML) based on the last version of the World Health Organization classification and eligible to second or third line of treatment. * ECOG performance status ≤ 2 * Patients are able to understand, sign, and date the written informed consent form at screening visit prior to any protocol-specific procedures * Patients are able and willing to comply with study procedures as per protocol, including bone marrow biopsies Key Exclusion Criteria: * Patients eligible to a standard of care * Patients eligible to hematopoietic stem cell transplantation (HSCT) at the time of inclusion * Patients diagnosed with acute promyelocytic leukemia (M3) * Patients with clinically active CNS leukemia * Patients with HSCT within 100 days prior to the first administration of AB8939 * Women who are lactating/breastfeeding or who plan to breastfeed while on study * Women with a positive pregnancy test Other protocol-defined inclusion/exclusion criteria may apply

Study sites (1)

TX