PBSS1113 in Combination With Azacitidine to Treat Patients With AML/MDS
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
Acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS) are highly heterogeneous myeloid malignancies where few effective targeted therapies are available. While venetoclax has significantly advanced the treatment landscape, therapeutic resistance remains a critical challenge. Consequently, patients with relapsed or refractory (R/R) AML/MDS face a profound unmet medical need for novel therapeutic options. PBSS1113 has demonstrated robust anti-leukemic activity in both in vitro and in vivo models, alongside an acceptable safety profile in a Phase I study. This Phase Ib/II trial will evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of PBSS1113 in combination with azacitidine for treatment-naive unfit AML, R/R AML, and higher-risk MDS populations.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Wiek co najmniej 18 lat
- •Rozpoznanie ostrą białaczki szpikową (AML), która nie odpowiada na leczenie lub powróciła po leczeniu
- •Nowo rozpoznana białaczka szpikowa u pacjentów niezdolnych do intensywnej chemioterapii
- •Zespół mielodysplastyczny wysokiego ryzyka
- •Wystarczająco dobre funkcjonowanie organizmu (skala ECOG 0-2)
- •Oczekiwana przeżywalność co najmniej 3 miesiące
- •Prawidłowe wyniki testów wątroby, nerek i krwawienia
- •Zdolność do zrozumienia badania i wyrażenia pisemnej zgody
✗ Disqualifies
- •Rozpoznanie białaczki promielocytowej (APL)
- •Aktywny nowotwór w innym miejscu ciała
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Last updated (source)
- August 14, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (1)
The First Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, China
Trial contact
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 8/13/2026.
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