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RECRUITING
NCT07743112
PHASE2

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

Sponsor: Maxinovel Pty., Ltd.

View on ClinicalTrials.gov

Summary

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

43

Start Date

2025-09-05

Completion Date

2027-12-01

Last Updated

2026-08-03

Healthy Volunteers

No

Interventions

DRUG

MAX-40279

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.

DRUG

Azacitidine

Given by IV, 75 mg/m2

DRUG

Venetoclax

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

Locations (1)

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

Tianjin, China