Acute Myeloid LeukemiaPhase 2NCT07743112
A Phase 2 Study of MAX-40279 Combined With Venetoclax and Azacitidine in Unfit Newly Diagnosed Acute Myeloid Leukemia
A Phase 2 study testing MAX-40279, Azacitidine and Venetoclax in people with Acute Myeloid Leukemia, run by Maxinovel Pty., Ltd. at 1 site in China.
Trial summary
This is a prospective, multicenter, phase Ⅱ study consisting of dose escalation and ex-pansion stages in unfit newly diagnosed AML. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myeloid Leukemia
- What is being tested?
- MAX-40279, Azacitidine and Venetoclax
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteChina
- Study dates
- 5 Sep 2025to 1 Dec 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. 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≤3×109/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
Who cannot join
- 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)
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Institute of Institute of Hematology & Blood Diseases Hospital ( Chinese Academy of Medical Sciences)
Tianjin
jianxiang Wang, MD, 86-22-23909278, wangjx@ihcams.ac.cn
About this study
This is a prospective, multicenter, phase Ⅱ study consisting of dose escalation and ex-pansion stages in unfit newly diagnosed AML.
Read the detailed description
This is a prospective, multicenter, phase Ⅱ study consisting of dose escalation and ex-pansion stages in unfit newly diagnosed AML. Patients in dose escalation stage received oral MAX-40279 at three doses, in combination with VEN and AZA in 28-day cycles. Three to six patients were enrolled at each dose level. The dose limiting toxicities (DLTs) observation period was 28 days after the first dose. All evaluable patients with ≥1 cycle treatment were included in preliminary efficacy analysis.
- Conditions
- Acute Myeloid Leukemia
- Being tested
- MAX-40279, Azacitidine, Venetoclax
- Keywords
- Unfit AML
- Medical subject headings
- Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MAX-40279Drug
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.
AzacitidineDrug
Also called Vidaza
Given by IV, 75 mg/m2
VenetoclaxDrug
Also called VENCLEXTA
100 mg on day 1, 200 mg on day 2, and 400 mg daily thereafter.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Drug: MAX-40279; Drug: Azacitidine; Drug: Venetoclax |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: Dose escalation; an average of 6 months.
CRc
complete remission rate
Measured: Through study completion; an average of 24 months.
Secondary outcomes (3)
RFS
Recurrence-Free Survival
Measured: Through study completion; an average of 8 months.
DoR
duration of response
Measured: Through study completion; an average of 8 months.
OS
overall survival
Measured: Through study completion; an average of 24 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2026
- Study start5 Sep 2025
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a prospective, multicenter, phase Ⅱ study consisting of dose escalation and ex-pansion stages
- Masking
- None (open label)
- Enrolment
- 43 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maxinovel Pty., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jianxiang Wang, MD, Principal investigator, Institute of Institute of Hematology & Blood Diseases Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07743112
- Sponsor's protocol ID
- MAX-40279-010
- Other IDs
- CTR20250827
- Status last verified
- Jul 2026
- First submitted
- 29 Jul 2026
- Last updated
- 3 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Study of MAX-40279 Combined With Venetoclax and Azacitidine in Unfit Newly Diagnosed Acute Myeloid Leukemia
- ClinicalTrials.gov ID
- NCT07743112
- Acronym / sponsor ID
- MAX-40279-010
- Conditions
- Acute Myeloid Leukemia
- Keywords
- Unfit AML
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 43 participants (estimated)
- Lead sponsor
- Maxinovel Pty., Ltd.Industry (pharma, biotech, devices)
- Study start
- 5 Sep 2025 (actual)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 3 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective, multicenter, phase Ⅱ study consisting of dose escalation and ex-pansion stages in unfit newly diagnosed AML.
Detailed description
This is a prospective, multicenter, phase Ⅱ study consisting of dose escalation and ex-pansion stages in unfit newly diagnosed AML. Patients in dose escalation stage received oral MAX-40279 at three doses, in combination with VEN and AZA in 28-day cycles. Three to six patients were enrolled at each dose level. The dose limiting toxicities (DLTs) observation period was 28 days after the first dose. All evaluable patients with ≥1 cycle treatment were included in preliminary efficacy analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a prospective, multicenter, phase Ⅱ study consisting of dose escalation and ex-pansion stages
| Arm | Type | Receives |
|---|---|---|
| MAX-40279 Combined with Venetoclax and Azacitidine in unfit newly diagnosed AML | Experimental | Drug: MAX-40279, Drug: Azacitidine, Drug: VenetoclaxPatients 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 1. 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≤3×109/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
Key exclusion criteria (12 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MAX-40279Dose 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. | Drug | MAX-40279 Combined with Venetoclax and Azacitidine in unfit newly diagnosed AML |
| AzacitidineAlso: VidazaGiven by IV, 75 mg/m2 | Drug | MAX-40279 Combined with Venetoclax and Azacitidine in unfit newly diagnosed AML |
| VenetoclaxAlso: VENCLEXTA100 mg on day 1, 200 mg on day 2, and 400 mg daily thereafter. | Drug | MAX-40279 Combined with Venetoclax and Azacitidine in unfit newly diagnosed AML |
Primary outcome
DLT
Time frame: Dose escalation; an average of 6 months.
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
Adverse events (AEs), serious adverse events (SAEs)
Time frame: Through study completion; an average of 24 months.
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Maximum Tolerated Dose (MTD) or Recommended Phase 2 Dose (RP2D)
Time frame: Dose escalation; an average of 6 months.
Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
CRc
Time frame: Through study completion; an average of 24 months.
complete remission rate
3 secondary outcomes
RFS
Time frame: Through study completion; an average of 8 months.
DoR
Time frame: Through study completion; an average of 8 months.
OS
Time frame: Through study completion; an average of 24 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jianxiang Wang, MD principal investigator
Institute of Institute of Hematology & Blood Diseases Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MAX-40279, Azacitidine and Venetoclax in people with Acute Myeloid Leukemia, run by Maxinovel Pty., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jing Wang (8621-61009600, jwang@maxinovel.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DLT (time frame: Dose escalation; an average of 6 months.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2026.