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AB8939 in Patients With Relapsed/Refractory Acute Myeloid Leukemia

Primary Purpose

Acute Myeloid Leukemia Refractory, Acute Myeloid Leukemia, in Relapse, Myelodysplastic Syndrome Acute Myeloid Leukemia

Status
Recruiting
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
AB8939
Azacitidine
Sponsored by
AB Science
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Myeloid Leukemia Refractory

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • MD Anderson Cancer Center
  • Institut Paoli Calmettes
  • National and Kapodistrian University of Athens NKUA · Department of Hematology and Bone marrow Transplantation UnitRecruiting
  • General University Hospital of Alicantet (Hospital General Universitario Dr. Balmis de Alicante)Recruiting
  • Hospital San Pedro de AlcantaraRecruiting
  • Hospital Universitario 12 de OctubreRecruiting
  • Hospital Universitario QuirónsaludRecruiting
  • MD Anderson Cancer Center MadridRecruiting
  • Clínica Universidad de NavarraRecruiting
  • Virgen del Rocío University Hospital (Hospital Universitario Virgen del Rocío)Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

AB8939

AB8939 plus azacitidine

Arm Description

AB8939 administered as a single agent

AB8939 administered in combination with azacitidine

Outcomes

Primary Outcome Measures

Rate of dose limiting toxicity (DLT)
Identification of the Maximal Tolerated Dose for different dosing schedules

Secondary Outcome Measures

Objective Response Rate
The proportion of patients who have a partial or complete response to therapy

Full Information

First Posted
January 12, 2022
Last Updated
October 6, 2023
Sponsor
AB Science
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1. Study Identification

Unique Protocol Identification Number
NCT05211570
Brief Title
AB8939 in Patients With Relapsed/Refractory Acute Myeloid Leukemia
Official Title
A Phase 1/2 Study to Assess the Safety, Pharmacokinetics, and Efficacy of Daily Intravenous AB8939 in Patients With Relapsed/Refractory Acute Myeloid Leukemia
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2022 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AB Science

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
Detailed Description
This is a Phase 1/2, open-label, multi-center, non-randomized, 2-part study in patients with refractory and relapsed AML and refractory myelodysplastic syndrome. Study AB18001 has a multi-stage design. The first part is a dose escalation study that aims to determine the safety, tolerability and pharmacokinetic profiles of consecutive daily intravenous administration of AB8939 in patients with refractory or relapsed AML or patients with refractory myelodysplastic syndrome, and to determine the recommended dose for the second-stage dose expansion study. This dose expansion study aims to determine the schedule for a Phase 2 trial in patients with relapsed/refractory AML and to also provide an early efficacy assessment of AB8939.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myeloid Leukemia Refractory, Acute Myeloid Leukemia, in Relapse, Myelodysplastic Syndrome Acute Myeloid Leukemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Sequential Assignment
Model Description
Open-label, multi-centre, non-randomized, 2-part study
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
78 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
AB8939
Arm Type
Experimental
Arm Description
AB8939 administered as a single agent
Arm Title
AB8939 plus azacitidine
Arm Type
Experimental
Arm Description
AB8939 administered in combination with azacitidine
Intervention Type
Drug
Intervention Name(s)
AB8939
Intervention Description
Intravenous injection (from an initial dose of 0.9 mg/m²)
Intervention Type
Drug
Intervention Name(s)
Azacitidine
Intervention Description
Subcutaneous injection (75 mg/m²)
Primary Outcome Measure Information:
Title
Rate of dose limiting toxicity (DLT)
Description
Identification of the Maximal Tolerated Dose for different dosing schedules
Time Frame
Up to 56 days
Secondary Outcome Measure Information:
Title
Objective Response Rate
Description
The proportion of patients who have a partial or complete response to therapy
Time Frame
Up to 56 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Clinical Study Coordinator
Phone
+33(0)147200014
Email
clinical@ab-science.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Norbert Vey, MD
Organizational Affiliation
Institut Paoli Calmettes, Marseille, France
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Nicholas Short, MD
Organizational Affiliation
MD Anderson Cancer Center, Houston, Texas
Official's Role
Principal Investigator
Facility Information:
Facility Name
MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Institut Paoli Calmettes
City
Marseille
Country
France
Individual Site Status
Not yet recruiting
Facility Name
National and Kapodistrian University of Athens NKUA · Department of Hematology and Bone marrow Transplantation Unit
City
Athens
Country
Greece
Individual Site Status
Recruiting
Facility Name
General University Hospital of Alicantet (Hospital General Universitario Dr. Balmis de Alicante)
City
Alicante
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital San Pedro de Alcantara
City
Cáceres
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario 12 de Octubre
City
Madrid
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Quirónsalud
City
Madrid
Country
Spain
Individual Site Status
Recruiting
Facility Name
MD Anderson Cancer Center Madrid
City
Madrid
Country
Spain
Individual Site Status
Recruiting
Facility Name
Clínica Universidad de Navarra
City
Pamplona
Country
Spain
Individual Site Status
Recruiting
Facility Name
Virgen del Rocío University Hospital (Hospital Universitario Virgen del Rocío)
City
Sevilla
Country
Spain
Individual Site Status
Recruiting

12. IPD Sharing Statement

Citations:
Citation
Goubard A, Humbert M, Mansfield C, Hermine O, Dubreuil P, et al. In Vivo Assessment of the Next Generation Microtubule-Destabilizing Agent AB8939 in Patient-derived Xenograft Models of Acute Myeloid Leukemia. Blood (2019) 134 (Supplement_1): 5142. doi.org/10.1182/blood-2019-127143
Results Reference
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Citation
Goubard A, Humbert M, Mansfield C, Hermine O, Dubreuil P, et al. AB8939, a Microtubule-Destabilizing Agent with Potential to Overcome Multidrug Resistance, is Active Across the Range (M0-M7) of Acute Myeloid Leukemia Subtypes. Blood (2019) 134 (Supplement_1): 5154. doi.org/10.1182/blood-2019-127021
Results Reference
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Citation
Humbert M, Goubard A, Mansfield C, Hermine O, Dubreuil P, et al. Anticancer Activity of a Highly Potent Small Molecule Tubulin Polymerization Inhibitor, AB8939. Blood (2019) 134 (Supplement_1): 2075. doi.org/10.1182/blood-2019-122540
Results Reference
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AB8939 in Patients With Relapsed/Refractory Acute Myeloid Leukemia

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