Study ASTX030-01 is a multi-phase study comprising of Phases 1-3 Monotherapy arms, and Phase 1 and Phase 2 Combination Therapy arms. Phase 1 Monotherapy consists of an open-label Dose Escalation Stage (Stage A) using multiple cohorts at escalating dose levels of oral cedazuridine and azacitidine (only one study drug will be escalated at a time) followed by a Dose Expansion Stage (Stage B). Phase 2 Monotherapy is a randomized, open-label, crossover study to compare oral ASTX030 to subcutaneous (SC) azacitidine. Phase 3 Monotherapy is a randomized open-label crossover study comparing the final fixed dose of oral ASTX030 to SC azacitidine. Phase 1 Combination Therapy is an open-label, multicenter, randomized, exploratory study comparing ASTX030 and SC azacitidine in combination with venetoclax in participants with treatment-naïve AML. Phase 2 Combination Therapy is an open-label, single arm, study evaluating the efficacy, safety, pharmacokinetics (PK), and drug interactions of ASTX030 in combination with venetoclax in participants with treatment-naïve AML. The duration of this multi-phase study is approximately 8 years.
Evaluate the Safety, Tolerability, Pharmacokinetic Profile, Efficacy of Bl-M11D1
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
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About the trial
The objective of this study to evaluate the safety, tolerability, pharmacokinetic profile, and preliminary efficacy of BL-M11D1 in patients with relapsed/refractory acute myeloid leukemia.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Wiek co najmniej 18 lat
- •Przewidywana długość życia co najmniej 3 miesiące
- •Potwierdzony nawrót lub oporność na leczenie ostrej białaczki szpikowej ze zmianą CD33
- •Dobra funkcja wątroby i nerek
- •Zgoda na stosowanie antykoncepcji podczas badania i przez 7 miesięcy po ostatniej dawce leku
- •Kobiety w wieku rozrodczym muszą mieć ujemny test ciąży
✗ Disqualifies
- •Rzadka postać białaczki zwana białaczką promielocytarną
- •Chemioterapia lub inne leczenie przeciwnowotworowe w ostatnich 2 tygodniach (lub 6 tygodni dla niektórych leków)
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Last updated (source)
- September 24, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (18)
City of Hope
Duarte, United States
UCLA Ronald Reagan Medical Center
Los Angeles, United States
University of Colorado Anschutz Medical Campus
Aurora, United States
Yale Cancer Center, Smilow Cancer Hospital at Yale New Haven
New Haven, United States
Moffitt Cancer Center
Tampa, United States
Northwestern Memorial Hospital
Chicago, United States
The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, United States
START Midwest/The Cancer and Hematology Center
Grand Rapids, United States
John Theurer Cancer Center-Hackensack
Hackensack, United States
Oncology Hematology Care Clinical Trials, LLC
Cincinnati, United States
The Ohio State University Comprehensive Cancer Center
Columbus, United States
WVCI Oncology Associates of Oregon
Eugene, United States
Oregon Health and Science University
Portland, United States
Temple Health Fox Chase Cancer Center
Philadelphia, United States
SCRI -TriStar BMT
Nashville, United States
MD Anderson Cancer Center
Houston, United States
Virginia Cancer Specialists
Fairfax, United States
Fred Hutchinson Cancer Center
Seattle, United States
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/22/2026.
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