A Phase 2 Study of MAX-40279 Combined With Venetoclax and Azacitidine in Unfit Newly Diagnosed Acute Myeloid Leukemia

NCT07743112 | Recruiting Phase 2

• 2 other identifiers: MAX-40279-010CTR20250827
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective, multicenter, phase Ⅱ study consisting of dose escalation and ex-pansion stages in unfit newly diagnosed AML.

Conditions

Acute Myeloid Leukemia

Keywords

Unfit AML

Outcome Measures

Primary Outcomes (4)

• DLT

  The dose limiting toxicities, Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

  Dose escalation; an average of 6 months.

• Adverse events (AEs), serious adverse events (SAEs)

  Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

  Through study completion; an average of 24 months.

• Maximum Tolerated Dose (MTD) or Recommended Phase 2 Dose (RP2D)

  Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

  Dose escalation; an average of 6 months.

• CRc

  complete remission rate

  Through study completion; an average of 24 months.

Secondary Outcomes (3)

• RFS

  Through study completion; an average of 8 months.

• DoR

  Through study completion; an average of 8 months.

• OS

  Through study completion; an average of 24 months.

Study Arms (1)

MAX-40279 Combined with Venetoclax and Azacitidine in unfit newly diagnosed AML

EXPERIMENTAL

Patients in dose escalation stage received oral MAX-40279 at 40 mg, 50 mg, and 60 mg twice daily (BID), in combination with VEN (100 mg on day 1, 200 mg on day 2, and 400 mg daily thereafter) and AZA (75 mg/m2 days 1-7) in 28-day cycles. Patients in dose expansion stage received RP2D MAX-40279 plus VEN (100 mg on day 1, 200 mg on day 2, and 400 mg daily thereafter) and AZA (75 mg/m2 days 1-7).

Drug: MAX-40279; Drug: Azacitidine; Drug: Venetoclax

Interventions

MAX-40279 DRUG

Dose escalation：MAX-40279: 40 mg, 50 mg, and 60 mg twice daily (BID). Dose expantion: MAX-40279 RP2D. Venetoclax: 100 mg on day 1, 200 mg on day 2, and 400 mg daily thereafter. Azacitidine: 75 mg/m2 days 1-7. 28 days are one cycle.

MAX-40279 Combined with Venetoclax and Azacitidine in unfit newly diagnosed AML

Azacitidine DRUG

Given by IV, 75 mg/m2

Also known as: Vidaza

MAX-40279 Combined with Venetoclax and Azacitidine in unfit newly diagnosed AML

Venetoclax DRUG

100 mg on day 1, 200 mg on day 2, and 400 mg daily thereafter.

Also known as: VENCLEXTA

MAX-40279 Combined with Venetoclax and Azacitidine in unfit newly diagnosed AML

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Patients meeting the World Health Organization (WHO) 2016 diagnostic criteria for newly diagnosed acute myeloid leukemia (AML) patients unfit for intensive chemotherapy:
• Age ≥65 years, or
• Age \>18 years and ineligible for standard-dose chemotherapy, defined by ≥1 of the following:
• ECOG performance status 2 or 3；History of chronic heart failure (CHF) requiring treatment or left ventricular ejection fraction (LVEF) ≤50% DLCO ≤65% or FEV1 ≤65%Creatinine clearance ≥30 mL/min but ≤45 mL/min (Cockcroft-Gault)、Any other condition deemed incompatible with standard chemotherapy (requires PI approval) 2. No prior AML therapy, except:Hydroxyurea. 3. ECOG performance status ≤3 4. Laboratory requirements: WBC≤3×10\*9/L、AST/ALT/ALP ≤3×ULN (except: due to leukemic involvement)、Total bilirubin ≤1.5×ULN、Serum creatinine clearance ≥30 mL/min (measured or calculated) 5. Life expectancy ≥3 months 6. Contraception requirements: Negative pregnancy test for women of childbearing potential；Agreement to use effective contraception during treatment and for 6 months after therapy

You may not qualify if:

• AML with BCR::ABL1 fusion、Acute promyelocytic leukemia (APL).
• Secondary AML, including:Therapy-related AML (per WHO classification)、AML with prior history of myelodysplastic syndrome (MDS) or myeloproliferative neoplasm (MPN).
• Use of strong/moderate CYP3A4 inducers within 3 days prior to treatment initiation.
• Hypersensitivity to any study drugs.
• Active malignancy in other organs (requiring treatment).
• Active cardiac disease, defined as ≥1 of the following:Myocardial infarction within 6 months before enrollment；History of symptomatic arrhythmia requiring medication；Uncontrolled/symptomatic congestive heart failure (NYHA Class \>2)
• Active infections, including:Untreated tuberculosis or any aspergillosis.
• Known HIV, active hepatitis B (HBV), or hepatitis C (HCV).
• Central nervous system (CNS) leukemia at baseline.
• Conditions limiting oral drug absorption (e.g., malabsorption syndrome).
• Medical history of:Epilepsy requiring medication、Dementia or psychiatric disorders impairing protocol compliance.
• Investigator's discretion for ineligibility.

Sponsors & Collaborators

• Maxinovel Pty., Ltd.: lead

Study Sites (1)

Institute of Institute of Hematology & Blood Diseases Hospital ( Chinese Academy of Medical Sciences)

Tianjin, China

RECRUITING

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

Azacitidine; venetoclax

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Aza Compounds; Organic Chemicals; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Study Officials

• Jianxiang Wang, MD

  Institute of Institute of Hematology & Blood Diseases Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jing Wang

CONTACT

8621-61009600; jwang@maxinovel.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a prospective, multicenter, phase Ⅱ study consisting of dose escalation and ex-pansion stages

Study Record Dates

• First Submitted: July 29, 2026
• First Posted: August 3, 2026
• Study Start: September 5, 2025
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: August 3, 2026

Record last verified: 2026-07

Locations

CN (1)