OncoMatch/Clinical Trials/NCT07761533
PBSS1113 in Combination With Azacitidine to Treat Patients With AML/MDS
Is NCT07761533 recruiting? Yes, currently enrolling (Sep 2026). This Phase 1/2 trial studies PBSS1113 for acute myeloid leukemia (aml).
Treatment: PBSS1113 — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Acute Myeloid Leukemia
Myelodysplastic Syndrome
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: allogeneic hematopoietic stem cell transplantation
Exception: allowed if no evidence of active GVHD and not requiring systemic immunosuppressive therapy for GVHD
Prior allogeneic hematopoietic stem cell transplantation (HSCT) with evidence of active graft-versus-host disease (GVHD), or requiring systemic immunosuppressive therapy for GVHD
Lab requirements
Blood counts
APTT ≤ 1.5 × ULN; PT ≤ 1.5 × ULN; INR ≤ 1.5 × ULN
Kidney function
Serum creatinine ≤ 1.5 × ULN
Liver function
Total bilirubin (TBIL) ≤ 1.5 × ULN; AST and ALT ≤ 3 × ULN
Cardiac function
QTcF < 450 ms for males and < 470 ms for females
Baseline organ function meeting the following laboratory criteria: Hepatic: TBIL ≤ 1.5 × ULN; AST and ALT ≤ 3 × ULN. Renal: Serum creatinine ≤ 1.5 × ULN. Coagulation: APTT ≤ 1.5 × ULN; PT ≤ 1.5 × ULN; INR ≤ 1.5 × ULN. Cardiac: QTcF < 450 ms for males and < 470 ms for females.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT07761533 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior allogeneic hematopoietic stem cell transplantation disqualifies patients from enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify